Register entryShortage reported
- Registered sites
- 0
- Active NDC listings
- 60
- Labeller names
- 3
- Live patents
- 200
- Exclusivities
- 1
- Shortage listings
- 4
- Countries
- 0
Alert
Drug shortage listings
4| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Dexmedetomidine Hydrochloride InjectionAnesthesia | Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (4 ug/1 mL) (NDC 72572-127-10) | Current | Available | 10 Apr 202016 Sept 2026 |
| Dexmedetomidine Hydrochloride InjectionAnesthesia | Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 72572-128-08) | Current | Available | 10 Apr 202016 Sept 2026 |
| Dexmedetomidine Hydrochloride InjectionAnesthesia | Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (4 ug/1 mL) (NDC 52536-125-10) | Current | Available | 10 Apr 202016 Sept 2026 |
| Dexmedetomidine Hydrochloride InjectionAnesthesia | Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 52536-126-08) | Current | Available | 10 Apr 202016 Sept 2026 |
Catalogue
Drug listings by form and route
6060 active NDC listings: 56 human prescription drug, 2 bulk ingredient, 2 human otc drug. By marketing category: NDA 48, ANDA 10, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 2.
| Dosage form | NDCs |
|---|---|
| tablet | 17 |
| solution | 14 |
| kit | 9 |
| injection | 4 |
| suspension | 4 |
| capsule, gelatin coated | 3 |
| injection, solution | 2 |
| lotion | 2 |
| solution, concentrate | 2 |
| powder, for solution | 1 |
| tablet, film coated | 1 |
| wafer | 1 |
| Route | NDCs |
|---|---|
| oral | 42 |
| intravenous | 4 |
| intramuscular | 2 |
| topical | 2 |
| intracavitary | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| azurity pharmaceuticals, inc. | 55 |
| azurity pharmaceuticals, inc | 4 |
| azurity pharmaceuticals | 1 |
Exclusivity
Patents and exclusivities
200| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 8026279 | HORIZANTgabapentin enacarbil | substance, product | Nov 2026 |
| 10124132 | ONZETRA XSAILsumatriptan succinate | product | Mar 2027 |
| 9107837 | CONTRAVEbupropion hydrochloride; naltrexone hydrochloride | use | Jun 2027 |
| 10307376 | CONTRAVEbupropion hydrochloride; naltrexone hydrochloride | use | Nov 2027 |
| 12048769 | CONTRAVEbupropion hydrochloride; naltrexone hydrochloride | use | Nov 2027 |
| 8318788 | CONTRAVEbupropion hydrochloride; naltrexone hydrochloride | use | Nov 2027 |
| 8722085 | CONTRAVEbupropion hydrochloride; naltrexone hydrochloride | use | Nov 2027 |
| 9125868 | CONTRAVEbupropion hydrochloride; naltrexone hydrochloride | use | Nov 2027 |
| 10398859 | ONZETRA XSAILsumatriptan succinate | product | Dec 2027 |
| 8371292 | ALVESCO, OMNARIS, ZETONNAciclesonide | use | Feb 2028 |
| 9066936 | EDARBI, EDARBYCLORazilsartan kamedoxomil; azilsartan kamedoxomil; chlorthalidone | product | Mar 2028 |
| 8875704 | ONZETRA XSAILsumatriptan succinate | product | Apr 2028 |
| 10722667 | ONZETRA XSAILsumatriptan succinate | product | Dec 2028 |
| 8088786 | CONTRAVEbupropion hydrochloride; naltrexone hydrochloride | product | Feb 2029 |
| 10085974 | DUAKLIR PRESSAIR, TUDORZA PRESSAIRaclidinium bromide; aclidinium bromide; formoterol fumarate | product | Mar 2029 |
| 11000517 | DUAKLIR PRESSAIR, TUDORZA PRESSAIRaclidinium bromide; aclidinium bromide; formoterol fumarate | product | Mar 2029 |
| 11324741 | CONTRAVEbupropion hydrochloride; naltrexone hydrochloride | use | May 2029 |
| 8795725 | HORIZANTgabapentin enacarbil | product | Jun 2029 |
| 10166181 | TRIPTODUR KITtriptorelin pamoate | product | Jun 2029 |
| 10076615 | ONZETRA XSAILsumatriptan succinate | use | Jul 2029 |
| 8550073 | ONZETRA XSAILsumatriptan succinate | product | Oct 2029 |
| 8916195 | CONTRAVEbupropion hydrochloride; naltrexone hydrochloride | use | Feb 2030 |
| 9169238 | EDARBYCLORazilsartan kamedoxomil; chlorthalidone | product | Feb 2030 |
| 8899229 | ONZETRA XSAILsumatriptan succinate | product | Aug 2030 |
| 9649456 | ONZETRA XSAILsumatriptan succinate | product | Oct 2030 |
| 8978647 | ONZETRA XSAILsumatriptan succinate | product | Dec 2030 |
| 11033543 | CONTRAVEbupropion hydrochloride; naltrexone hydrochloride | use | Jan 2031 |
| 9387249 | EDARBYCLORazilsartan kamedoxomil; chlorthalidone | use | Jul 2031 |
| 9248123 | CONTRAVEbupropion hydrochloride; naltrexone hydrochloride | use | Jan 2032 |
| 8568747 | EPANED KITenalapril maleate | product | Nov 2032 |
| 8778366 | EPANED KITenalapril maleate | use | Nov 2032 |
| 9855214 | EPANED KITenalapril maleate | product | Nov 2032 |
| 9968553 | EPANED KITenalapril maleate | use | Nov 2032 |
| 10231927 | XATMEPmethotrexate sodium | use | Jan 2033 |
| 10610485 | XATMEPmethotrexate sodium | product | Jan 2033 |
| 11116724 | XATMEPmethotrexate sodium | use | Jan 2033 |
| 11969503 | XATMEPmethotrexate sodium | product | Jan 2033 |
| 12396947 | XATMEPmethotrexate sodium | product | Jan 2033 |
| 9259427 | XATMEPmethotrexate sodium | product | Jan 2033 |
| 9855215 | XATMEPmethotrexate sodium | product | Jan 2033 |
| 10403170 | CONTRAVEbupropion hydrochloride; naltrexone hydrochloride | use | Jun 2033 |
| 11139056 | CONTRAVEbupropion hydrochloride; naltrexone hydrochloride | use | Jun 2033 |
| 9633575 | CONTRAVEbupropion hydrochloride; naltrexone hydrochloride | use | Jun 2033 |
| 10478574 | ONZETRA XSAILsumatriptan succinate | use | Nov 2033 |
| 10206895 | SOTYLIZEsotalol hydrochloride | product | Apr 2034 |
| 11013703 | SOTYLIZEsotalol hydrochloride | product | Apr 2034 |
| 12290495 | SOTYLIZEsotalol hydrochloride | use | Apr 2034 |
| 10231964 | CONTRAVEbupropion hydrochloride; naltrexone hydrochloride | use | Jul 2034 |
| 10828294 | CONTRAVEbupropion hydrochloride; naltrexone hydrochloride | use | Jul 2034 |
| 10835527 | CONTRAVEbupropion hydrochloride; naltrexone hydrochloride | use | Jul 2034 |
| 11998542 | CONTRAVEbupropion hydrochloride; naltrexone hydrochloride | use | Jul 2034 |
| 10076614 | ONZETRA XSAILsumatriptan succinate | product | Oct 2034 |
| 11850222 | SOTYLIZEsotalol hydrochloride | use | Nov 2034 |
| 10493028 | FIRVANQ KITvancomycin hydrochloride | product | Mar 2035 |
| 10688046 | FIRVANQ KITvancomycin hydrochloride | product | Mar 2035 |
| 10959946 | FIRVANQ KITvancomycin hydrochloride | product | Mar 2035 |
| 10959947 | FIRVANQ KITvancomycin hydrochloride | product | Mar 2035 |
| 10959948 | FIRVANQ KITvancomycin hydrochloride | product | Mar 2035 |
| 10959949 | FIRVANQ KITvancomycin hydrochloride | product | Mar 2035 |
| 11638692 | FIRVANQ KITvancomycin hydrochloride | product | Mar 2035 |
| Product | Exclusivity | Until |
|---|---|---|
| WIDAPLIKAMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN | NP New product | Jun 2028 |
Catalogue
Marketed products
61Showing 60 of 61.
| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ARYNTA | lisdexamfetamine dimesylate oral | solution, oral | 24338-019NDA |
| ARYNTA | lisdexamfetamine dimesylate oral | solution, oral | 24338-103NDA |
| ARYNTA | lisdexamfetamine dimesylate oral | solution, oral | 24338-109NDA |
| ARYNTA | lisdexamfetamine dimesylate oral | solution, oral | 24338-160NDA |
| ARYNTA | lisdexamfetamine dimesylate oral | solution, oral | 24338-162NDA |
| AZMIRO | TESTOSTERONE CYPIONATE | injection, solution, intramuscular | 24338-055NDA |
| AZMIRO | TESTOSTERONE CYPIONATE | injection, solution, intramuscular | 24338-056NDA |
| BRYNOVIN | Sitagliptin Hydrochloride Oral | solution, oral | 24338-017NDA |
| BiDil | Hydralazine hydrochloride and Isosorbide dinitrate | tablet, film coated, oral | 24338-010NDA |
| DANZITEN | nilotinib | tablet, oral | 24338-154NDA |
| DANZITEN | nilotinib | tablet, oral | 24338-155NDA |
| - | Diphenhydramine Hydrochloride and Lidocaine Hydrochloride and Aluminum Hydroxide and Magnesium Hydro | kit | 65628-050BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| Edarbi | Azilsartan kamedoxomil | tablet, oral | 60631-040NDA |
| Edarbi | Azilsartan kamedoxomil | tablet, oral | 60631-080NDA |
| Epaned | enalapril maleate | solution, oral | 52652-4001NDA |
| Eprontia | Topiramate | solution, oral | 52652-9001NDA |
| Evekeo | Amphetamine Sulfate | tablet, oral | 24338-022ANDA |
| Evekeo | Amphetamine Sulfate | tablet, oral | 24338-026ANDA |
| FIRVANQ | vancomycin hydrochloride | kit | 65628-204NDA |
| FIRVANQ | vancomycin hydrochloride | kit | 65628-205NDA |
| FIRVANQ | vancomycin hydrochloride | kit | 65628-206NDA |
| FIRVANQ | vancomycin hydrochloride | kit | 65628-208NDA |
| FLEQSUVY | baclofen | suspension, oral | 52652-6001NDA |
| FeraBright | Ferumoxytol | injection, intravenous | 24338-310NDA |
| FeraBright | Ferumoxytol | injection, intravenous | 24338-510NDA |
| Gleostine | lomustine | capsule, gelatin coated, oral | 24338-340NDA |
| Gleostine | lomustine | capsule, gelatin coated, oral | 24338-341NDA |
| Gleostine | lomustine | capsule, gelatin coated, oral | 24338-342NDA |
| Gliadel | carmustine | wafer, intracavitary | 24338-050NDA |
| GoLYTELY | Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride | powder, for solution, oral | 24338-236NDA |
| Ivermectin | Ivermectin | lotion, topical | 24338-119ANDA |
| JAVADIN | clonidine hydrochloride oral | solution, oral | 24338-115NDA |
| Katerzia | Amlodipine | suspension, oral | 52652-5001NDA |
| Konvomep | omeprazole and sodium bicarbonate | kit | 65628-272NDA |
| MYHIBBIN | MYCOPHENOLATE MOFETIL | suspension, oral | 24338-018NDA |
| - | Metronidazole Benzoate | kit | 65628-202BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| Nymalize | nimodipine | solution, oral | 24338-230NDA |
| Nymalize | nimodipine | solution, oral | 24338-260NDA |
| Qbrelis | lisinopril | solution, oral | 52652-3001NDA |
| SOTYLIZE | SOTALOL HYDROCHLORIDE | solution, oral | 24338-530NDA |
| SUFLAVE | polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution | kit | 24338-550NDA |
| SUPREP Bowel Prep | sodium sulfate, potassium sulfate, magnesium sulfate | solution, concentrate, oral | 24338-175NDA |
| SUPREP Bowel Prep | sodium sulfate, potassium sulfate, magnesium sulfate | solution, concentrate, oral | 24338-177NDA |
| SUTAB | sodium sulfate, magnesium sulfate, and potassium chloride | tablet, oral | 24338-201NDA |
| Sklice | ivermectin | lotion, topical | 24338-185NDA |
| TRIPTODUR | triptorelin | kit | 24338-150NDA |
| VIVIMUSTA | BENDAMUSTINE HYDROCHLORIDE | injection, intravenous | 24338-270NDA |
| WIDAPLIK | telmisartan, amlodipine and indapamide | tablet, oral | 24338-001NDA |
| WIDAPLIK | telmisartan, amlodipine and indapamide | tablet, oral | 24338-002NDA |
| WIDAPLIK | telmisartan, amlodipine and indapamide | tablet, oral | 24338-003NDA |
| XIFYRM | meloxicam | injection, intravenous | 24338-153NDA |
| Xatmep | Methotrexate | solution, oral | 52652-2001NDA |
| ZONISADE | ZONISAMIDE | suspension, oral | 52652-8001NDA |
| Zenzedi | Dextroamphetamine Sulfate | tablet, oral | 24338-850ANDA |
| Zenzedi | Dextroamphetamine Sulfate | tablet, oral | 24338-851ANDA |
| Zenzedi | Dextroamphetamine Sulfate | tablet, oral | 24338-852ANDA |
| Zenzedi | Dextroamphetamine Sulfate | tablet, oral | 24338-853ANDA |
| Zenzedi | Dextroamphetamine Sulfate | tablet, oral | 24338-854ANDA |
| Zenzedi | Dextroamphetamine Sulfate | tablet, oral | 24338-855ANDA |
| Zenzedi | Dextroamphetamine Sulfate | tablet, oral | 24338-856ANDA |
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Enquiry
Common questions
- Is Azurity Pharmaceuticals, Inc. FDA approved?
- Azurity Pharmaceuticals, Inc. holds no registered establishment of its own; 61 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
- What drugs does Azurity Pharmaceuticals, Inc. make?
- 61 products are listed under Azurity Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as tablet; solution; kit. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
- Are any Azurity Pharmaceuticals, Inc. products in shortage?
- 4 presentations are currently listed in the FDA drug shortage database under Azurity Pharmaceuticals, Inc., covering Dexmedetomidine Hydrochloride Injection.
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.