Organon LLC
NDC labeler codes: 78206, 81672
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- MirtazapineRemeronsoltab, Remeron · 5 products
- Adalimumab-attoAmjevita, Hyrimoz, Hadlima · 5 products
- Mometasone furoateAsmanex HFA, Asmanex, Sinuva · 5 products
- MontelukastSingulair · 4 products
- Ezetimibe and simvastatinVytorin · 4 products
- Losartan potassium and hydrochlorothiazideHyzaar · 3 products
- Mometasone furoate and formoterol fumarate dihydrateDulera · 3 products
- Losartan potassiumLosortan Potassium, Cozaar, Arbli · 3 products
- SimvastatinZocor · 3 products
- TocilizumabTyenne, Tofidence, Actemra · 3 products
- FollitropinGonal-F Rff Redi-Ject, Follistim Aq · 3 products
- Carbidopa and levodopaCrexont, Rytary, Sinemet · 2 products
- DenosumabBomyntra, Bildyos, Xtrenbo · 2 products
- Rizatriptan benzoateRizafilm, Maxalt-Mlt, Maxalt · 2 products
- FinasteridePropecia, Proscar · 2 products
- Alendronate sodium and cholecalciferolFosamax Plus D · 2 products
- DesloratadineClarinex · 2 products
- Desloratadine and pseudoephedrine sulfateClarinex-D 12 Hour · 1 product
- Betamethasone dipropionateDiprolene, Sernivo · 1 product
- EzetimibeZetia · 1 product
- Betamethasone sodium phosphate and betamethasone acetateCelestone Soluspan · 1 product
- InfliximabRemicade, Renflexis, Inflectra · 1 product
- ClindamycinCleocin Phosphate, Cleocin Hydrochloride, Clindamycin Phoaphate Topical Solution Usp, 1% · 1 product
- TapinarofVtama · 1 product
- CopperParagard T 380a, Miudella · 1 product
- Alendronate sodiumBinosto, Fosamax · 1 product
- EtonogestrelNexplanon · 1 product
- TrastuzumabOgivri, Kanjinti, Herzuma · 1 product
- Ganirelix acetateFyremadel · 1 product
- Etonogestrel and ethinyl estradiolNuvaring, Enilloring, Eluryng · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| August 29, 2025 | BLA761444 | Denosumab BILDYOS, BILPREVDA | Shanghai Henlius Biotech |
| February 24, 2025 | NDA218201 | Copper MIUDELLA | Sebela Womens Hlth |
| September 29, 2023 | BLA761354 | Tocilizumab TOFIDENCE | Biogen Ma |
| May 23, 2022 | NDA215272 | Tapinarof VTAMA | Organon LLC |
| December 7, 2021 | NDA215650 | Clindamycin XACIATO | Organon LLC |
| July 23, 2019 | BLA761059 | Adalimumab-atto HADLIMA | Samsung Bioepis Co Ltd |
| January 18, 2019 | BLA761100 | Trastuzumab ONTRUZANT | Samsung Bioepis Co Ltd |
| April 21, 2017 | BLA761054 | Infliximab RENFLEXIS | Samsung Bioepis Co Ltd |
| April 25, 2014 | NDA205641 | Mometasone furoate ASMANEX HFA | Organon LLC |
| June 22, 2010 | NDA022518 | Mometasone furoate and formoterol fumarate dihydrate DULERA | Organon LLC |
| July 17, 2006 | NDA021529 | Etonogestrel IMPLANON, NEXPLANON | Organon |
| February 1, 2006 | NDA021313 | Desloratadine and pseudoephedrine sulfate CLARINEX-D 12 HOUR | Organon LLC |
| April 7, 2005 | NDA021762 | Alendronate sodium and cholecalciferol FOSAMAX PLUS D | Organon LLC |
| March 30, 2005 | NDA021067 | Mometasone furoate ASMANEX TWISTHALER | Organon LLC |
| July 23, 2004 | NDA021687 | Ezetimibe and simvastatin VYTORIN | Organon |
| March 23, 2004 | BLA021211 | Follitropin FOLLISTIM AQ | Organon USA LLC |
| October 25, 2002 | NDA021445 | Ezetimibe ZETIA | Organon |
| July 26, 2002 | NDA021409 | Montelukast SINGULAIR | Organon |
| December 21, 2001 | NDA021165 | Desloratadine CLARINEX | Organon |
| October 3, 2001 | NDA021187 | Etonogestrel and ethinyl estradiol NUVARING | Organon USA Organon |
| January 12, 2001 | NDA021208 | Mirtazapine REMERON SOLTAB | Organon USA Organon |
| July 29, 1999 | NDA021057 | Ganirelix acetate GANIRELIX ACETATE | Organon USA Organon |
| June 29, 1998 | NDA020864 | Rizatriptan benzoate MAXALT | Organon LLC |
| June 29, 1998 | NDA020865 | Rizatriptan benzoate MAXALT-MLT | Organon |
| February 20, 1998 | NDA020829 | Montelukast SINGULAIR | Organon |
Show the other 11 applications
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| February 20, 1998 | NDA020830 | Montelukast SINGULAIR | Organon |
| December 19, 1997 | NDA020788 | Finasteride PROPECIA | Organon |
| June 14, 1996 | NDA020415 | Mirtazapine REMERON | Organon |
| September 29, 1995 | NDA020560 | Alendronate sodium FOSAMAX | Organon |
| April 28, 1995 | NDA020387 | Losartan potassium and hydrochlorothiazide HYZAAR | Organon |
| April 14, 1995 | NDA020386 | Losartan potassium COZAAR | Organon |
| June 19, 1992 | NDA020180 | Finasteride PROSCAR | Organon |
| December 23, 1991 | NDA019766 | Simvastatin ZOCOR | Organon |
| July 27, 1983 | NDA018741 | Betamethasone dipropionate DIPROLENE | Organon |
| May 2, 1975 | NDA017555 | Carbidopa and levodopa SINEMET | Organon |
| March 3, 1965 | NDA014602 | Betamethasone sodium phosphate and betamethasone acetate CELESTONE SOLUSPAN | Organon |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2025
-
October 10, 2025 · Class II · Ongoing · D-0099-2026 · Adalimumab-atto
Lack of Assurance of Sterility.
HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured by: SAMSUN BIOEPIS
2024
-
May 28, 2024 · Class III · Ongoing · D-0550-2024 · Mometasone furoate
Defective Container
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-02
-
May 28, 2024 · Class III · Ongoing · D-0551-2024 · Mometasone furoate
Defective Container
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 14 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-03
2022
-
January 26, 2022 · Class II · Terminated · D-0169-2024 · Mometasone furoate
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation), 120 Metered Doses, Rx only, Manufactured for: Organon LLC, a subsidiary of Organon & Co., Jersey City, NJ 07302; Manufactured by: MSD Inte
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
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- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026