Register entry
Bayer Healthcare Manufacturing Srl
Data as of · How to read this entry
- Registered sites
- 13
- Active NDC listings
- 360
- Labeller names
- 8
- Live patents
- 156
- Exclusivities
- 6
- Countries
- 6
- Base
- Germany
Authorisation
Registered operations
Analytical testing11Active ingredient (API) manufacture7Labelling8Finished drug manufacture9Packaging10particle size reduction2Repackaging1sterilize2
Sites
Registered establishments
13| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Bayer AG | Ernst-Schering-Str. 14, Bergkamen, 59192, Germany (DEU) | Analytical testing, Active ingredient (API) manufacture | 3002808084314398484 |
| Bayer AG | Mullerstr. 178, Berlin, 13353, Germany (DEU) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, sterilize | 3002808086315097875 |
| Bayer AktiengesellschaftRegistrant: Bayer AG | Max-Dohrn-Str. 8, Berlin, 10589, Germany (DEU) | Analytical testing, Packaging, particle size reduction | 3002808063342872971 |
| Bayer Bitterfeld GmbHRegistrant: Bayer HealthCare LLC | Salegaster Chaussee 1, Bitterfeld-Wolfen, Saxony-Anhalt 06803, Germany (DEU) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3003882513330908898 |
| Bayer AG | Kaiser-Wilhelm-Allee 101-103, Leverkusen, NW 51368, Germany (DEU) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, particle size reduction | 3002806462314947622 |
| Bayer AG | Friedrich-Ebert-Str. 217-333, Wuppertal, 42117, Germany (DEU) | Analytical testing, Active ingredient (API) manufacture, Packaging | 3003229486323208116 |
| Bayer Hispania, S.L.Registrant: Bayer HealthCare LLC | CALLE SABINO ALONSO FUEYO 77, LANGREO/LLANGREU, Asturias 33934, Spain (ESP) | Active ingredient (API) manufacture | 3002988759462205374 |
| Bayer Oy | Pansiontie 47, Turku, 20210, Finland (FIN) | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 1000350927369758383 |
| Bayer Healthcare Manufacturing Srl | Via Delle Groane 126, Garbagnate-Milanese, 20024, Italy (ITA) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3002806461630762938 |
| Bayer de Mexico, S.A. de C.V.Registrant: Bayer HealthCare LLC | Mexico-Toluca Km. 52.5, Lerma, 52000, Mexico (MEX) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3002806479588165709 |
| Bayer HealthCare LLC | 800 Dwight Way, Berkeley, California (CA) 94710, United States (USA) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 2910913127769128 |
| Bayer HealthCare LLC | 36 Columbia Rd, Morristown, New Jersey (NJ) 07960, United States (USA) | Finished drug manufacture | 2243252785159372 |
| BAYER HEALTHCARE LLCRegistrant: Bayer HealthCare LLC | 400 W Stoever Ave, Myerstown, Pennsylvania (PA) 17067-1418, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging, Repackaging | 2510692072827066 |
Catalogue
Drug listings by form and route
360360 active NDC listings: 216 human otc drug, 61 human prescription drug, 55 drug for further processing, 18 bulk ingredient, 10 plasma derivative. By marketing category: OTC MONOGRAPH DRUG 160, NDA 104, DRUG FOR FURTHER PROCESSING 57, BULK INGREDIENT 18, BLA 11.
| Dosage form | NDCs |
|---|---|
| kit | 47 |
| tablet, effervescent | 41 |
| tablet | 39 |
| tablet, film coated | 37 |
| capsule, liquid filled | 32 |
| powder | 24 |
| capsule | 20 |
| tablet, chewable | 19 |
| injection | 18 |
| aerosol, powder | 9 |
| cream | 9 |
| spray, metered | 9 |
| patch | 8 |
| powder, for solution | 7 |
| spray | 6 |
| Route | NDCs |
|---|---|
| oral | 187 |
| topical | 27 |
| intravenous | 18 |
| nasal | 15 |
| transdermal | 8 |
| intra-arterial | 4 |
| intrauterine | 3 |
| oropharyngeal | 2 |
| Labeller name on the listing | NDCs |
|---|---|
| bayer healthcare llc. | 223 |
| bayer healthcare pharmaceuticals inc. | 62 |
| bayer ag | 34 |
| bayer healthcare llc | 24 |
| bayer healthcare llc. | 11 |
| bayer healthcare llc | 3 |
| bayer healthcare, llc. | 2 |
| bayer healthcare manufacturing srl | 1 |
Exclusivity
Patents and exclusivities
156| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 7173037 | ADEMPASriociguat | substance, product | Dec 2026 |
| 11628088 | KYLEENA, SKYLAlevonorgestrel | product | Feb 2027 |
| 8273876 | LEVITRAvardenafil hydrochloride | use | Jul 2027 |
| 7683056 | LYNKUETelinzanetant | substance, product | Sept 2027 |
| 8877933 | NEXAVARsorafenib tosylate | substance, product | Dec 2027 |
| 8153616 | NATAZIAdienogest; estradiol valerate | use | Jan 2028 |
| 9737488 | NEXAVARsorafenib tosylate | product | Sept 2028 |
| 8613950 | STAXYNvardenafil hydrochloride | product | Dec 2028 |
| 11850182 | KYLEENA, MIRENA, SKYLAlevonorgestrel | product | Sept 2029 |
| 10561524 | KYLEENA, MIRENA, SKYLAlevonorgestrel | use | Sept 2029 |
| 10005783 | VITRAKVIlarotrectinib sulfate | use | Oct 2029 |
| 10047097 | VITRAKVIlarotrectinib sulfate | use | Oct 2029 |
| 10774085 | VITRAKVIlarotrectinib sulfate | use | Oct 2029 |
| 8865698 | VITRAKVIlarotrectinib sulfate | use | Oct 2029 |
| 9127013 | VITRAKVIlarotrectinib sulfate | substance, product | Oct 2029 |
| 9447104 | VITRAKVIlarotrectinib sulfate | use | Oct 2029 |
| 9676783 | VITRAKVIlarotrectinib sulfate | use | Oct 2029 |
| RE46856 | ALIQOPAcopanlisib dihydrochloride | substance, product | Oct 2029 |
| 8513263 | VITRAKVIlarotrectinib sulfate | substance, product | Dec 2029 |
| 8617597 | BEYAZ, SAFYRALdrospirenone; ethinyl estradiol; levomefolate calcium | product | Feb 2030 |
| 8680124 | STIVARGAregorafenib | use | Jun 2030 |
| 11617751 | BEYAZ, SAFYRALdrospirenone; ethinyl estradiol; levomefolate calcium | product | Jul 2030 |
| 10711013 | NUBEQAdarolutamide | substance, product | Oct 2030 |
| 11046713 | NUBEQAdarolutamide | substance | Oct 2030 |
| 9657003 | NUBEQAdarolutamide | substance, product | Oct 2030 |
| 8637553 | STIVARGAregorafenib | substance, product | Feb 2031 |
| 9458107 | STIVARGAregorafenib | product | Apr 2031 |
| 8906890 | ANGELIQdrospirenone; estradiol | product | Oct 2031 |
| 10383876 | ALIQOPAcopanlisib dihydrochloride | substance, product | Mar 2032 |
| 9636344 | ALIQOPAcopanlisib dihydrochloride | use | Mar 2032 |
| 9957232 | STIVARGAregorafenib | substance | Jul 2032 |
| 8975254 | NUBEQAdarolutamide | substance, product | Mar 2033 |
| 8436180 | KERENDIAfinerenone | substance, product | Aug 2033 |
| 10662188 | ADEMPASriociguat | substance, product | Feb 2034 |
| 11203593 | ADEMPASriociguat | substance, product | Feb 2034 |
| 12503469 | ADEMPASriociguat | product | Feb 2034 |
| RE49826 | KERENDIAfinerenone | substance | Jul 2035 |
| 10428063 | HYRNUOsevabertinib | substance, product | Oct 2035 |
| 10172861 | VITRAKVIlarotrectinib sulfate | substance, product | Nov 2035 |
| 10285993 | VITRAKVIlarotrectinib sulfate | use | Nov 2035 |
| 10813936 | VITRAKVIlarotrectinib sulfate | use | Nov 2035 |
| 9782414 | VITRAKVIlarotrectinib sulfate | use | Nov 2035 |
| 10010530 | NUBEQAdarolutamide | substance | Jan 2036 |
| 10383853 | NUBEQAdarolutamide | substance | Jan 2036 |
| 10835515 | NUBEQAdarolutamide | product | Jan 2036 |
| 10195205 | LYNKUETelinzanetant | use | May 2036 |
| 10137209 | AMBELVISTgadoquatrane | substance | May 2036 |
| 10722601 | AMBELVISTgadoquatrane | substance | May 2036 |
| 11491245 | AMBELVISTgadoquatrane | substance | May 2036 |
| 12478696 | AMBELVISTgadoquatrane | substance | May 2036 |
| 10799505 | VITRAKVIlarotrectinib sulfate | substance, product | Aug 2036 |
| 10045991 | VITRAKVIlarotrectinib sulfate | use | Apr 2037 |
| 10137127 | VITRAKVIlarotrectinib sulfate | product | Apr 2037 |
| 10668072 | VITRAKVIlarotrectinib sulfate | product | Apr 2037 |
| 11191766 | VITRAKVIlarotrectinib sulfate | use | Apr 2037 |
| 11484535 | VITRAKVIlarotrectinib sulfate | use | Apr 2037 |
| 11337967 | VITRAKVIlarotrectinib sulfate | use | May 2037 |
| 11974998 | VITRAKVIlarotrectinib sulfate | use | May 2037 |
| 11168058 | NUBEQAdarolutamide | substance, product | Feb 2038 |
| 10774091 | LYNKUETelinzanetant | product | Mar 2039 |
| Product | Exclusivity | Until |
|---|---|---|
| AMBELVISTGADOQUATRANE | NCE New chemical entity | Jun 2031 |
| HYRNUOSEVABERTINIB | NCE New chemical entity | Nov 2030 |
| KERENDIAFINERENONE | I-970 New indication | Jul 2028 |
| KERENDIAFINERENONE | NS New strength | Jul 2028 |
| LYNKUETELINZANETANT | NCE New chemical entity | Oct 2030 |
| NUBEQADAROLUTAMIDE | I-971 New indication | Jun 2028 |
Catalogue
Marketed products
360Showing 150 of 360.
| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ALKA SELTZER COLD Cold Congestion Severe Day Night Fast Dissolve | aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate | kit, oral | 0280-8285OTC MONOGRAPH DRUG |
| ALKA SELTZER COLD Cold Cough Maximum Strength Fast Gels | acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride | capsule, liquid filled, oral | 0280-8275OTC MONOGRAPH DRUG |
| ALKA SELTZER COLD Cold Flu And Congestion Severe Fast Hot Liquid Day | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE | powder, for solution, oral | 0280-8273OTC MONOGRAPH DRUG |
| ALKA SELTZER COLD Cold Flu Congestion Severe Fast Hot Liquid Day Night | Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride, and Doxylamine succinate | kit | 0280-8284OTC MONOGRAPH DRUG |
| ALKA SELTZER COLD Cold Flu Severe Fast Dissolve | chlorpheniramine maleate, acetaminophen, dextromethorphan hydrobromide | tablet, effervescent, oral | 0280-8280OTC MONOGRAPH DRUG |
| ALKA SELTZER COLD Cold Flu and Congestion Fast Dissolve | chlorpheniramine maleate, dextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride | tablet, effervescent, oral | 0280-8274OTC MONOGRAPH DRUG |
| ALKA SELTZER COLD Cold Flu and Congestion Maximum Strength Day Night Fast Gels | Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride, Doxylamine succinate | kit | 0280-8288OTC MONOGRAPH DRUG |
| ALKA SELTZER COLD Cold Flu and Congestion Severe Fast Dissolve | chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide | tablet, effervescent, oral | 0280-8268OTC MONOGRAPH DRUG |
| ALKA SELTZER COLD Cold Flu and Congestion Severe Fast Dissolve | chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide | tablet, effervescent, oral | 0280-8271OTC MONOGRAPH DRUG |
| ALKA SELTZER COLD Cold Flu and Congestion Severe Night Fast Gels | acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride | capsule, liquid filled, oral | 0280-8282OTC MONOGRAPH DRUG |
| ALKA SELTZER COLD Cold Mucus and Congestion Maximum Strength Day Night Fast Gels | acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride | kit, oral | 0280-8286OTC MONOGRAPH DRUG |
| ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast Gels | Acetaminophen, Dextromethorphan hydrobromide , Doxylamine Succinate, Phenylephrine hydrochloride | capsule, liquid filled, oral | 0280-8276OTC MONOGRAPH DRUG |
| ALKA SELTZER COLD Cold and Cough Fast | acetaminophen, dextromethorphan hydrobromide | tablet, chewable, oral | 0280-8279OTC MONOGRAPH DRUG |
| ALKA SELTZER COLD Cold and Cough Maximum Strength Fast Dissolve | aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate | tablet, effervescent, oral | 0280-8267OTC MONOGRAPH DRUG |
| ALKA SELTZER COLD Cold and Flu Severe Day Night Fast Dissolve | Aspirin, Dextromethorphan hydrobromide, Phenylephrine bitartrate, Doxylamine succinate | kit, oral | 0280-8287OTC MONOGRAPH DRUG |
| ALKA SELTZER COLD Cold and Flu Severe Fast Chewables | chlorpheniramine maleate, acetaminophen, dextromethorphan hydrobromide | tablet, chewable, oral | 0280-8269OTC MONOGRAPH DRUG |
| ALKA SELTZER COLD Cold and Flu plus Congestion Severe Fast Hot Liquid Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE | powder, for solution, oral | 0280-8272OTC MONOGRAPH DRUG |
| ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve | aspirin, chlorpheniramine maleate, phenylephrine bitartrate | tablet, effervescent, oral | 0280-8270OTC MONOGRAPH DRUG |
| ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve Orange | aspirin, chlorpheniramine maleate, phenylephrine bitartrate | tablet, effervescent, oral | 0280-8266OTC MONOGRAPH DRUG |
| ALKA SELTZER COLD Cold and Sinus Maximum Strength Day Night Fast Gels | Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride, Doxylamine succinate | kit | 0280-8283OTC MONOGRAPH DRUG |
| ALKA SELTZER COLD Cold and Sinus Maximum Strength Fast Gels | Acetaminophen, Dextromethorphan hydrobromide , Phenylephrine hydrochloride | capsule, liquid filled, oral | 0280-8281OTC MONOGRAPH DRUG |
| - | ASP Free Cold and Flu Ni.LF. BLM | capsule | 0280-1210DRUG FOR FURTHER PROCESSING |
| - | ASP SS CA C LG BLM | capsule | 0280-1220DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, Guaifenesin | capsule, liquid filled | 0280-1104DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen, Dextromethorphan hydrobromide, Doxylamine hydrogen succinate | capsule, liquid filled | 11523-0524DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen, Guafenesin | capsule | 11523-0085DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen, Guafenesin | capsule | 11523-0163DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen, Phenylephrine, Dextromethorphan Hydrobromide, Doxylamine Succinate | capsule | 0280-1201DRUG FOR FURTHER PROCESSING |
| Adempas | riociguat | tablet, film coated, oral | 50419-250NDA |
| Adempas | riociguat | tablet, film coated, oral | 50419-251NDA |
| Adempas | riociguat | tablet, film coated, oral | 50419-252NDA |
| Adempas | riociguat | tablet, film coated, oral | 50419-253NDA |
| Adempas | riociguat | tablet, film coated, oral | 50419-254NDA |
| Afrin Allergy Sinus Nasal | oxymetazoline hydrochloride | spray, nasal | 11523-0073OTC MONOGRAPH DRUG |
| Afrin No Drip Extra Moisturizing | Oxymetazoline hydrochloride | spray, metered, nasal | 11523-1783OTC MONOGRAPH DRUG |
| Afrin No Drip Original Pump Mist | Oxymetazoline hydrochloride | spray, metered, nasal | 11523-3142OTC MONOGRAPH DRUG |
| Afrin No Drip Pump Mist Bundle Pack | Oxymetazoline hydrochloride | kit, nasal | 11523-0147OTC MONOGRAPH DRUG |
| Afrin No Drip Severe Congestion | Oxymetazoline hydrochloride | spray, metered, nasal | 11523-1350OTC MONOGRAPH DRUG |
| Afrin No-Drip Allergy Sinus | Oxymetazoline hydrochloride | spray, metered, nasal | 11523-3220OTC MONOGRAPH DRUG |
| Afrin NoDrip Allergy Sinus Night | oxymetazoline hydrochloride | spray, nasal | 11523-0034OTC MONOGRAPH DRUG |
| Afrin Original | Oxymetazoline hydrochloride | spray, nasal | 11523-1167OTC MONOGRAPH DRUG |
| Afrin Original Nasal | OXYMETAZOLINE HYDROCHLORIDE | spray, nasal | 11523-1168OTC MONOGRAPH DRUG |
| Afrin Original Pump Mist | Oxymetazoline hydrochloride | spray, metered, nasal | 11523-1159OTC MONOGRAPH DRUG |
| Afrin Severe Congestion | Oxymetazoline hydrochloride | spray, nasal | 11523-7020OTC MONOGRAPH DRUG |
| Aleve | NAPROXEN SODIUM | tablet, oral | 0280-0113NDA |
| Aleve | NAPROXEN SODIUM | tablet, oral | 0280-6010NDA |
| Aleve | Naproxen Sodium | capsule, liquid filled, oral | 0280-6080NDA |
| Aleve Arthritis Pain Gel | Diclofenac Sodium | gel, topical | 0280-0039ANDA |
| Aleve Back and Muscle Pain | NAPROXEN SODIUM | tablet, oral | 0280-0111NDA |
| Aleve Back and Muscle Pain | Naproxen Sodium | tablet, oral | 0280-6092NDA |
| Aleve Caplets | NAPROXEN SODIUM | tablet, oral | 0280-0114NDA |
| Aleve Caplets | NAPROXEN SODIUM | tablet, oral | 0280-6000NDA |
| Aleve Caplets - Easy Open Arthritis Cap | NAPROXEN SODIUM | tablet, oral | 0280-6050NDA |
| Aleve Caplets Easy Open Arthritis | NAPROXEN SODIUM | tablet, oral | 0280-0130NDA |
| Aleve Caplets Soft Grip Arthritis | NAPROXEN SODIUM | tablet, oral | 0280-0115NDA |
| Aleve Easy Open Arthritis | NAPROXEN SODIUM | tablet, oral | 0280-0131NDA |
| Aleve Easy Open Arthritis Cap | NAPROXEN SODIUM | tablet, oral | 0280-6060NDA |
| Aleve Easy Open Arthritis Cap | Naproxen Sodium | capsule, liquid filled, oral | 0280-6091NDA |
| Aleve Gelcaps | NAPROXEN SODIUM | tablet, coated, oral | 0280-6020NDA |
| Aleve Gelcaps | NAPROXEN SODIUM | tablet, coated, oral | 0280-6070NDA |
| Aleve Headache Pain | Naproxen Sodium | tablet, oral | 0280-0041NDA |
| Aleve Headache Pain | NAPROXEN SODIUM | tablet, oral | 0280-0112NDA |
| Aleve Headache Pain | NAPROXEN SODIUM | tablet, oral | 0280-8252NDA |
| Aleve PM | DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM | tablet, film coated, oral | 0280-1200NDA |
| Aleve liquid gels | Naproxen Sodium | capsule, liquid filled, oral | 0280-0105ANDA |
| Aleve-D Sinus and Cold | naproxen sodium, pseudeoephedrine hydrochloride | tablet, oral | 0280-6090ANDA |
| Aleve-D Sinus and Headache | naproxen sodium, pseudoephedrine hydrochloride | tablet, oral | 0280-6045ANDA |
| AleveX | camphor and menthol | spray, topical | 0280-0049OTC MONOGRAPH DRUG |
| AleveX | camphor and menthol | lotion, topical | 0280-0050OTC MONOGRAPH DRUG |
| AleveX | camphor and menthol | lotion, topical | 0280-0063OTC MONOGRAPH DRUG |
| Alka Seltzer COLD Cold Mucus Congestion Maximum Strength Fast Gels | acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride | capsule, liquid filled, oral | 0280-8294OTC MONOGRAPH DRUG |
| Alka Seltzer Cold Cold and Congestion Severe Night Fast Dissolve | aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate | tablet, effervescent, oral | 0280-8265OTC MONOGRAPH DRUG |
| - | Alka Seltzer Plus Free Cold and Flu Day Liqui-Gels | capsule | 0280-1205DRUG FOR FURTHER PROCESSING |
| Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizz | dextromethorphan hydrobromide, guaifenesin | tablet, effervescent, oral | 0280-0089OTC MONOGRAPH DRUG |
| Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max Gels | Acetaminophen, Dextromethorphan hydrobromide , Doxylamine Succinate, Phenylephrine hydrochloride | capsule, liquid filled, oral | 0280-0097OTC MONOGRAPH DRUG |
| Alka-Seltzer Cool Action Extra Strength ReliefChews Mint | Calcium Carbonate | tablet, chewable, oral | 0280-0058OTC MONOGRAPH DRUG |
| Alka-Seltzer Cool Action Heartburn Relief Mint | Calcium Carbonate | gum, chewing, oral | 0280-0001OTC MONOGRAPH DRUG |
| Alka-Seltzer Extra Strength | Anhydrous Citric Acid, Sodium Bicarbonate, and Aspirin | granule, effervescent, oral | 0280-0211OTC MONOGRAPH DRUG |
| Alka-Seltzer Extra Strength Heartburn ReliefChews | Calcium carbonate | tablet, chewable, oral | 0280-0042OTC MONOGRAPH DRUG |
| Alka-Seltzer Extra Strength Pain Relief | ANHYDROUS CITRIC ACID, ASPIRIN | tablet, effervescent, oral | 0280-8260OTC MONOGRAPH DRUG |
| Alka-Seltzer Gold | Alka-Seltzer Gold | tablet, effervescent, oral | 0280-4100OTC MONOGRAPH DRUG |
| Alka-Seltzer Hangover Relief | ANHYDROUS CITRIC ACID, ASPIRIN, and SODIUM BICARBONATE | tablet, effervescent, oral | 0280-0084OTC MONOGRAPH DRUG |
| Alka-Seltzer Heartburn | Anhydrous citric acid, Sodium bicarbonate (heat-treated) | tablet, effervescent, oral | 0280-0047OTC MONOGRAPH DRUG |
| Alka-Seltzer Heartburn Plus Gas ReliefChews Tropical Punch | CALCIUM CARBONATE AND SIMETHICONE | tablet, chewable, oral | 0280-0225OTC MONOGRAPH DRUG |
| Alka-Seltzer Heartburn Relief Extra Strength | Anhydrous citric acid, Sodium bicarbonate (heat-treated) | tablet, effervescent, oral | 0280-0079OTC MONOGRAPH DRUG |
| Alka-Seltzer Heartburn Relief Lemon Lime | Anhydrous citric acid, Sodium bicarbonate (heat-treated) | tablet, effervescent, oral | 0280-0083OTC MONOGRAPH DRUG |
| Alka-Seltzer Heartburn Relief Peppermint | calcium carbonate | gum, chewing, oral | 0280-0002OTC MONOGRAPH DRUG |
| Alka-Seltzer Heartburn ReliefChews | CALCIUM CARBONATE | tablet, chewable, oral | 0280-0221OTC MONOGRAPH DRUG |
| Alka-Seltzer Heartburn ReliefChews Strawberry and Orange | CALCIUM CARBONATE | tablet, chewable, oral | 0280-0224OTC MONOGRAPH DRUG |
| Alka-Seltzer Heartburn and Pain | ANHYDROUS CITRIC ACID, ASPIRIN, and SODIUM BICARBONATE | tablet, effervescent, oral | 0280-0160OTC MONOGRAPH DRUG |
| Alka-Seltzer Kids Tummy ReliefChews | calcium carbonate and dimethicone | tablet, chewable, oral | 0280-0051OTC MONOGRAPH DRUG |
| Alka-Seltzer Original | ANHYDROUS CITRIC ACID, ASPIRIN, and SODIUM BICARBONATE | tablet, effervescent, oral | 0280-4000OTC MONOGRAPH DRUG |
| Alka-Seltzer Original Flavor | Alka-Seltzer Original Flavor | tablet, effervescent, oral | 0280-0087OTC MONOGRAPH DRUG |
| Alka-Seltzer Pain Relief | Alka-Seltzer Pain Relief | tablet, effervescent, oral | 0280-8251OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Cold Day and Night | Aspirin, Dextromethorphan hydrobromide, Phenylephrine bitartrate, Doxylamine succinate | kit, oral | 0280-1550OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Cold Day and Night PowerMax gels | Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine bitartrate, Doxylamine succinate | kit, oral | 0280-0098OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Cold Day and Night PowerMax gels | Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine bitartrate, Doxylamine succinate | kit, oral | 0280-0099OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Cold Medicine Sparkling Original | ASPIRIN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE BITARTRATE | tablet, effervescent, oral | 0280-1400OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Cold Night | Aspirin, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine bitartrate | tablet, effervescent, oral | 0280-1545OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Cold Orange Zest | Aspirin, Chlorpheniramine Maleate, Phenylephrine bitartrate | tablet, effervescent, oral | 0280-1510OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Cold Sparkling Original | Aspirin, Chlorpheniramine maleate, Phenylephrine bitartrate | tablet, effervescent, oral | 0280-1520OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz | aspirin, chlorpheniramine maleate, phenylephrine bitartrate | tablet, effervescent, oral | 0280-0060OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Cold and Cough | Aspirin, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine bitartrate | tablet, effervescent, oral | 0280-1555OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Cold and Flu FizzyChews | chlorpheniramine maleate, acetaminophen, dextromethorphan hydrobromide | tablet, chewable, oral | 0280-0151OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Cough and Sore Throat FizzyChews | acetaminophen, dextromethorphan hydrobromide | tablet, chewable, oral | 0280-0152OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Cough, Mucus and Congestion Day and Night Powermax | acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride | kit, oral | 0280-0035OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Day Severe Cold Plus Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE | powder, for solution, oral | 0280-0921OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels | Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride | capsule, liquid filled, oral | 0280-1570OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Maximum Strength Cold and Cough Power Max Gels | Acetaminophen, Chlorpheniramine malaeate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride | capsule, liquid filled, oral | 0280-0092OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Day and Night | acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride | kit, oral | 0280-0062OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Powermax | acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride | capsule, liquid filled, oral | 0280-0061OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Maximum Strength Day Cold and Flu | Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride | capsule, liquid filled, oral | 0280-1590OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Maximum Strength Day Cold and Flu PowerMax Gels | acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride | capsule, liquid filled, oral | 0280-1630OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu | dextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride, doxylamine succinate | kit, oral | 0280-0040OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu | Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride | kit, oral | 0280-1580OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu | Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride | kit, oral | 0280-1581OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels | Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride, Doxylamine succinate | kit | 0280-0125OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels | Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride, Doxylamine succinate | kit | 0280-1650OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels | acetaminophen, dextrmethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride | kit | 0280-1680OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Maximum Strength Night Cold and Flu | Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride | capsule, liquid filled, oral | 0280-1600OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax Gels | acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride | capsule, liquid filled, oral | 0280-1640OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and Night | Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride | kit, oral | 0280-1610OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and Cough | Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride | capsule, liquid filled, oral | 0280-1620OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz | chlorpheniramine maleate, dextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride | tablet, effervescent, oral | 0280-0055OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels | Acetaminophen, Dextromethorphan hydrobromide , Phenylephrine hydrochloride | capsule, liquid filled, oral | 0280-0095OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and Night Liquid Gels | Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl | kit, oral | 0280-1138OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Night Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE | powder, for solution, oral | 0280-0922OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Severe Cold Night PowerFast Fizz | aspirin, doxylamine succinate, dextromethorphan hydrobromide, phenylephrine bitartrate | tablet, effervescent, oral | 0280-0068OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Severe Cold Night PowerFast Fizz | aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate | tablet, effervescent, oral | 0280-0121OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz | aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate, doxylamine succinate | kit, oral | 0280-0025OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night | aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate | kit, oral | 0280-0069OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night | aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate | kit, oral | 0280-0086OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night | aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate | kit, oral | 0280-0109OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night | aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate | kit | 0280-0110OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy | asprin, dextromethorphan hydrobromide, phenylephrine bitartrate | tablet, effervescent, oral | 0280-0024OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Orange Zest | aspirin, chlorpheniramine maleate, phenylephrine bitartrate | tablet, effervescent, oral | 0280-0020OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Severe Cold Powerfast Fizz Night | aspirin, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrate | tablet, effervescent, oral | 0280-0021OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz | aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate | tablet, effervescent, oral | 0280-0023OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz | chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide | tablet, effervescent, oral | 0280-0088OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Severe Cough Mucus and Congestion Day and Night | Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride, Guaifenesin | kit, oral | 0280-0506OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid Gels | Alka-Seltzer Plus Severe Cough Mucus and Congestion | capsule, liquid filled, oral | 0280-0505OTC MONOGRAPH DRUG |
| Alka-Seltzer Plus Severe Sinus Cold and Cough Liquid Gels | Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride | capsule, liquid filled, oral | 0280-0507OTC MONOGRAPH DRUG |
| Alka-Seltzer Ultra Strength Heartburn ReliefChews | Calcium carbonate | tablet, chewable, oral | 0280-0245OTC MONOGRAPH DRUG |
| Alka-Seltzer Ultra Strength Heartburn ReliefChews Strawberry and Orange | Calcium Carbonate | tablet, chewable, oral | 0280-0059OTC MONOGRAPH DRUG |
| Ambelvist | Gadoquatrane | injection, intravenous | 50419-321NDA |
| Ambelvist | Gadoquatrane | injection, intravenous | 50419-322NDA |
| Ambelvist | Gadoquatrane | injection, intravenous | 50419-323NDA |
| Ambelvist | Gadoquatrane | injection, intravenous | 50419-324NDA |
| Ambelvist | Gadoquatrane | injection, intravenous | 50419-326NDA |
| Ambelvist | Gadoquatrane | injection, intravenous | 50419-327NDA |
Neighbours
Registered in the same town
12- SGS North America Inc.Berlin, DEU
- WuXi Biologics Co., Ltd.Wuppertal, DEU
- Terumo Pharmaceutical Services GmbHLeverkusen, DEU
- Orion Corporation, Orion PharmaTurku, FIN
- Currenta GmbH & Co. OHGLeverkusen, DEU
- Novatech SABerlin, DEU
- Biofrontera Bioscience GmbHLeverkusen, DEU
- Chemische Fabrik Berg GmbHBitterfeld-Wolfen, DEU
- Dynamit Nobel GmbH Explosivstoff- und SystemtechnikLeverkusen, DEU
- Eckert & Ziegler Radiopharma GmbHBerlin, DEU
- Grimann SA de CVLerma, MEX
- Iron Lab SA de CVLerma, MEX
Compare
Comparable companies in Germany
- Evonik Operations GmbH11 sites · 18 NDC
- Ferring Pharmaceuticals Inc.9 sites · 17 NDC
- Takeda Pharmaceuticals U.S.A., Inc.7 sites · 226 NDC
- SGS North America Inc.19 sites · 0 NDC
- Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.5 sites · 0 NDC
- Corden Pharma International GmbH4 sites · 14 NDC
- Vetter Pharma Fertigung GmbH & Co. KG4 sites · 1 NDC
- Wacker Biotech GmbH4 sites · 1 NDC
- Boehringer Ingelheim Biopharmaceuticals China Ltd3 sites · 127 NDC
- Beiersdorf AG3 sites · 107 NDC
Enquiry
Common questions
- Is Bayer Healthcare Manufacturing Srl FDA approved?
- Bayer Healthcare Manufacturing Srl holds 13 FDA-registered establishments across 6 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are Bayer Healthcare Manufacturing Srl's drugs manufactured?
- At registered sites in Germany, Spain, Finland, Italy, Mexico, the United States. The FDA register lists Bergkamen; Berlin; Bitterfeld-Wolfen; Leverkusen; Wuppertal; LANGREO/LLANGREU, and 6 more. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, particle size reduction, repackaging, sterilize.
- What drugs does Bayer Healthcare Manufacturing Srl make?
- 360 products are listed under Bayer Healthcare Manufacturing Srl in the openFDA NDC Directory, most often as kit; tablet, effervescent; tablet. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.