Register entry
- Registered sites
- 4
- Active NDC listings
- 95
- Labeller names
- 3
- Live patents
- 18
- Exclusivities
- 3
- Shortage listings
- 1
- Countries
- 4
- Base
- Netherlands
Authorisation
Registered operations
Analytical testing4Active ingredient (API) manufacture2Labelling4Finished drug manufacture4Packaging4sterilize2
Sites
Registered establishments
4| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Organon HeistRegistrant: Organon LLC | Industriepark 30, Heist-op-den-Berg, 2220, Belgium (BEL) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, sterilize | 3003974846370199689 |
| ORGANON PHARMA (UK) LIMITEDRegistrant: Organon LLC | Shotton Lane, Cramlington, Northumberland, NE23 3JU, United Kingdom (GBR) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3002807653212559095 |
| Organon Pharma Mexico, S.A. de C.V.Registrant: Organon LLC | Av. 16 de Septiembre No. 301, Xaltocan, Xochimilco, Ciudad De Mexico 16090, Mexico (MEX) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3022529610810011890 |
| N.V. OrganonRegistrant: Organon LLC | Vollenhovermeer 2, Oss, 5347 JV, Netherlands (NLD) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, sterilize | 3002806821473511690 |
Alert
Drug shortage listings
1| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Montelukast Sodium Tablet, ChewablePulmonary/Allergy | Singulair, Tablet, Chewable, 4 mg (NDC 78206-170-01) | To Be Discontinued | - | 17 Nov 202517 Nov 2025 |
Catalogue
Drug listings by form and route
9595 active NDC listings: 70 human prescription drug, 25 drug for further processing. By marketing category: NDA 53, DRUG FOR FURTHER PROCESSING 25, BLA 17.
| Dosage form | NDCs |
|---|---|
| tablet, film coated | 28 |
| tablet | 20 |
| injection, solution | 7 |
| aerosol | 6 |
| solution | 5 |
| tablet, chewable | 4 |
| tablet, orally disintegrating | 4 |
| injection | 3 |
| granule | 2 |
| inhalant | 2 |
| injection, powder, lyophilized, for solution | 2 |
| insert, extended release | 2 |
| kit | 2 |
| cream | 1 |
| gel | 1 |
| Route | NDCs |
|---|---|
| oral | 37 |
| subcutaneous | 12 |
| respiratory (inhalation) | 8 |
| intravenous | 6 |
| topical | 2 |
| vaginal | 2 |
| intra-articular | 1 |
| intralesional | 1 |
| intramuscular | 1 |
| intrauterine | 1 |
| soft tissue | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| organon llc | 70 |
| organon pharma (uk) limited | 21 |
| n.v. organon | 4 |
Exclusivity
Patents and exclusivities
18| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 10821277 | NEXPLANONetonogestrel | product | May 2027 |
| 8722037 | NEXPLANONetonogestrel | product | Sept 2027 |
| 9757552 | IMPLANON, NEXPLANONetonogestrel | product | Jul 2030 |
| 10426743 | VTAMAtapinarof | use | May 2036 |
| 11458108 | VTAMAtapinarof | product | May 2036 |
| 11612573 | VTAMAtapinarof | use | May 2036 |
| 11617724 | VTAMAtapinarof | product | May 2036 |
| 11622945 | VTAMAtapinarof | product | May 2036 |
| 10195160 | VTAMAtapinarof | product | May 2036 |
| 11129896 | XACIATOclindamycin phosphate | use | Sept 2036 |
| 12303563 | XACIATOclindamycin phosphate | product | Sept 2036 |
| 10647649 | VTAMAtapinarof | substance | Nov 2038 |
| 11597692 | VTAMAtapinarof | substance, product | Nov 2038 |
| 11497718 | VTAMAtapinarof | use | Nov 2039 |
| 11590088 | VTAMAtapinarof | use | Nov 2039 |
| 11938099 | VTAMAtapinarof | use | Nov 2039 |
| 12569453 | VTAMAtapinarof | use | Dec 2039 |
| Product | Exclusivity | Until |
|---|---|---|
| NEXPLANONETONOGESTREL | D-199 New dosing schedule | Jan 2029 |
| VTAMATAPINAROF | I-956 New indication | Dec 2027 |
| XACIATOCLINDAMYCIN PHOSPHATE | GAIN Qualified infectious disease product (GAIN) | Dec 2029 |
Catalogue
Marketed products
95| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ASMANEX | Mometasone Furoate | inhalant, respiratory (inhalation) | 78206-114NDA |
| ASMANEX | Mometasone Furoate | inhalant, respiratory (inhalation) | 78206-115NDA |
| ASMANEX HFA | MOMETASONE FUROATE | aerosol, respiratory (inhalation) | 78206-111NDA |
| ASMANEX HFA | MOMETASONE FUROATE | aerosol, respiratory (inhalation) | 78206-112NDA |
| ASMANEX HFA | MOMETASONE FUROATE | aerosol, respiratory (inhalation) | 78206-113NDA |
| BILDYOS | Denosumab | injection, solution, subcutaneous | 78206-193BLA |
| Bilprevda | Denosumab | injection, solution, subcutaneous | 78206-195BLA |
| CELESTONE SOLUSPAN | Betamethasone Acetate and Betamethasone Sodium Phosphate | injection, suspension, intra-articular, intralesional, intramuscular, soft tissue | 78206-118NDA |
| CLARINEX-D 12 HOUR | desloratadine and pseudoephedrine sulfate | tablet, extended release, oral | 78206-120NDA |
| COZAAR | losartan potassium | tablet, film coated, oral | 78206-121NDA |
| COZAAR | losartan potassium | tablet, film coated, oral | 78206-122NDA |
| COZAAR | losartan potassium | tablet, film coated, oral | 78206-123NDA |
| Clarinex | Desloratadine | tablet, film coated, oral | 78206-119NDA |
| Clarinex | Desloratadine | tablet, film coated, oral | 78206-188NDA |
| DIPROLENE | betamethasone dipropionate | ointment, topical | 78206-124NDA |
| Dulera | mometasone furoate and formoterol fumarate dihydrate | aerosol, respiratory (inhalation) | 78206-125NDA |
| Dulera | mometasone furoate and formoterol fumarate dihydrate | aerosol, respiratory (inhalation) | 78206-126NDA |
| Dulera | mometasone furoate and formoterol fumarate dihydrate | aerosol, respiratory (inhalation) | 78206-127NDA |
| FOSAMAX | alendronate sodium | tablet, oral | 78206-135NDA |
| FOSAMAX PLUS D | ALENDRONATE SODIUM and CHOLECALCIFEROL | tablet, oral | 78206-136NDA |
| FOSAMAX PLUS D | ALENDRONATE SODIUM and CHOLECALCIFEROL | tablet, oral | 78206-137NDA |
| Follistim AQ | follitropin | injection, solution, subcutaneous | 78206-129BLA |
| Follistim AQ | follitropin | injection, solution, subcutaneous | 78206-130BLA |
| Follistim AQ | follitropin | injection, solution, subcutaneous | 78206-131BLA |
| Ganirelix Acetate | Ganirelix Acetate | injection, solution, subcutaneous | 78206-138NDA |
| HYZAAR | losartan potassium and hydrochlorothiazide | tablet, film coated, oral | 78206-139NDA |
| HYZAAR | losartan potassium and hydrochlorothiazide | tablet, film coated, oral | 78206-140NDA |
| HYZAAR | losartan potassium and hydrochlorothiazide | tablet, film coated, oral | 78206-141NDA |
| Hadlima | adalimumab-bwwd | solution, subcutaneous | 78206-183BLA |
| Hadlima | adalimumab-bwwd | solution, subcutaneous | 78206-184BLA |
| Hadlima | adalimumab-bwwd | solution, subcutaneous | 78206-185BLA |
| Hadlima | adalimumab-bwwd | solution, subcutaneous | 78206-186BLA |
| Hadlima | adalimumab-bwwd | solution, subcutaneous | 78206-187BLA |
| MAXALT | rizatriptan benzoate | tablet, oral | 78206-142NDA |
| MAXALT-MLT | rizatriptan benzoate | tablet, orally disintegrating, oral | 78206-143NDA |
| - | MIRTAZAPINE | tablet, film coated | 60312-0095DRUG FOR FURTHER PROCESSING |
| - | MIRTAZAPINE | tablet, film coated | 60312-0096DRUG FOR FURTHER PROCESSING |
| Miudella | Copper | intrauterine device, intrauterine | 78206-210NDA |
| Nexplanon | etonogestrel | implant, subcutaneous | 78206-145NDA |
| NuvaRing | etonogestrel and ethinyl estradiol | insert, extended release, vaginal | 78206-146NDA |
| Ontruzant | trastuzumab | injection, powder, lyophilized, for solution, intravenous | 78206-147BLA |
| Ontruzant | Ontruzant | kit, intravenous | 78206-148BLA |
| PROPECIA | finasteride | tablet, film coated, oral | 78206-152NDA |
| PROSCAR | FINASTERIDE | tablet, film coated, oral | 78206-153NDA |
| Pregnyl | CHORIOGONADOTROPIN ALFA | kit | 78206-150BLA |
| REMERON | MIRTAZAPINE | tablet, film coated, oral | 78206-160NDA |
| REMERON | MIRTAZAPINE | tablet, film coated, oral | 78206-161NDA |
| REMERONSOLTAB | MIRTAZAPINE | tablet, orally disintegrating, oral | 78206-156NDA |
| REMERONSOLTAB | MIRTAZAPINE | tablet, orally disintegrating, oral | 78206-158NDA |
| REMERONSOLTAB | MIRTAZAPINE | tablet, orally disintegrating, oral | 78206-159NDA |
| Renflexis | infliximab | injection, powder, lyophilized, for solution, intravenous | 78206-162BLA |
| - | SIMVASTATIN | tablet, film coated | 60312-0735DRUG FOR FURTHER PROCESSING |
| - | SIMVASTATIN | tablet, film coated | 60312-0740DRUG FOR FURTHER PROCESSING |
| - | SIMVASTATIN | tablet, film coated | 60312-0749DRUG FOR FURTHER PROCESSING |
| SINEMET | carbidopa and levodopa | tablet, oral | 78206-166NDA |
| SINEMET | carbidopa and levodopa | tablet, oral | 78206-167NDA |
| SINEMET | carbidopa and levodopa | tablet, oral | 78206-168NDA |
| SINEMET | carbidopa and levodopa | tablet, oral | 78206-190NDA |
| SINGULAIR | montelukast sodium | tablet, chewable, oral | 78206-170NDA |
| SINGULAIR | montelukast sodium | granule, oral | 78206-171NDA |
| SINGULAIR | montelukast sodium | tablet, film coated, oral | 78206-172NDA |
| SINGULAIR | montelukast sodium | tablet, chewable, oral | 78206-173NDA |
| - | SUGAMMADEX SODIUM | injection, solution | 12860-0001DRUG FOR FURTHER PROCESSING |
| - | Sitagliptin Phosphate | tablet | 60312-0107DRUG FOR FURTHER PROCESSING |
| - | Sitagliptin Phosphate | tablet | 60312-0108DRUG FOR FURTHER PROCESSING |
| - | Sitagliptin Phosphate | tablet | 60312-0109DRUG FOR FURTHER PROCESSING |
| TOFIDENCE | TOCILIZUMAB | injection, intravenous | 78206-200BLA |
| TOFIDENCE | TOCILIZUMAB | injection, intravenous | 78206-201BLA |
| TOFIDENCE | TOCILIZUMAB | injection, intravenous | 78206-202BLA |
| VTAMA | tapinarof | cream, topical | 81672-5051NDA |
| VYTORIN | ezetimibe and simvastatin | tablet, oral | 78206-174NDA |
| VYTORIN | ezetimibe and simvastatin | tablet, oral | 78206-175NDA |
| VYTORIN | ezetimibe and simvastatin | tablet, oral | 78206-176NDA |
| VYTORIN | ezetimibe and simvastatin | tablet, oral | 78206-177NDA |
| XACIATO | clindamycin phosphate | gel, vaginal | 78206-189NDA |
| ZOCOR | SIMVASTATIN | tablet, film coated, oral | 78206-180NDA |
| ZOCOR | SIMVASTATIN | tablet, film coated, oral | 78206-181NDA |
| ZOCOR | SIMVASTATIN | tablet, film coated, oral | 78206-182NDA |
| Zetia | Ezetimibe | tablet, oral | 78206-178NDA |
| - | etonogestrel and ethinyl estradiol | insert, extended release | 12860-0018DRUG FOR FURTHER PROCESSING |
| - | ezetimibe and simvastatin | tablet | 60312-0311DRUG FOR FURTHER PROCESSING |
| - | ezetimibe and simvastatin | tablet | 60312-0312DRUG FOR FURTHER PROCESSING |
| - | ezetimibe and simvastatin | tablet | 60312-0313DRUG FOR FURTHER PROCESSING |
| - | ezetimibe and simvastatin | tablet | 60312-0314DRUG FOR FURTHER PROCESSING |
| - | losartan potassium | tablet, film coated | 60312-0951DRUG FOR FURTHER PROCESSING |
| - | losartan potassium | tablet, film coated | 60312-0952DRUG FOR FURTHER PROCESSING |
| - | losartan potassium | tablet, film coated | 60312-0960DRUG FOR FURTHER PROCESSING |
| - | losartan potassium and hydrochlorothiazide | tablet, film coated | 60312-0717DRUG FOR FURTHER PROCESSING |
| - | losartan potassium and hydrochlorothiazide | tablet, film coated | 60312-0745DRUG FOR FURTHER PROCESSING |
| - | losartan potassium and hydrochlorothiazide | tablet, film coated | 60312-0747DRUG FOR FURTHER PROCESSING |
| - | montelukast sodium | tablet, film coated | 60312-0117DRUG FOR FURTHER PROCESSING |
| - | montelukast sodium | tablet, chewable | 60312-0275DRUG FOR FURTHER PROCESSING |
| - | montelukast sodium | tablet, chewable | 60312-0711DRUG FOR FURTHER PROCESSING |
| - | posaconazole | tablet, coated | 12860-0041DRUG FOR FURTHER PROCESSING |
| - | posaconazole | granule | 12860-0133DRUG FOR FURTHER PROCESSING |
Neighbours
Registered in the same town
4- Piramal Healthcare (Canada) LimitedNorthumberland, GBR
- Aspen Oss B.V.Oss, NLD
- BioChem Oss B.V.Oss, NLD
- Bioconnection B.V.Oss, NLD
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Enquiry
Common questions
- Is Organon LLC FDA approved?
- Organon LLC holds 4 FDA-registered establishments across 4 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 Organon LLC's drugs manufactured?
- At registered sites in Belgium, the United Kingdom, Mexico, the Netherlands. The FDA register lists Heist-op-den-Berg; Northumberland; Xochimilco; Oss. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, sterilize.
- What drugs does Organon LLC make?
- 95 products are listed under Organon LLC in the openFDA NDC Directory, most often as tablet, film coated; tablet; injection, solution. 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.