Drug company (FDA labeler)
Amici Pharma, Inc.
NDC labeler code: 69292
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
- RisperidoneUzedy, Risperdal, Risperdal M-Tab · 5 products
- Terazosin hydrochlorideTezruly · 4 products
- Captopril4 products
- Pravastatin sodium4 products
- Enalapril maleateVasotec, Epaned · 4 products
- Metolazone3 products
- Butalbital and acetaminophenTencon, Allzital · 3 products
- DiclofenacZipsor, Lofena, Cambia · 3 products
- GabapentinNeurontin, Gralise, Relgaabi · 3 products
- RoflumilastZoryve, Daliresp · 2 products
- MetronidazoleMetronidazole Vaginal, Metronidazole Vaginal Gel, Likmez · 2 products
- BupropionWellbutrin SR, Aplenzin, Wellbutrin XL · 2 products
- AmphetamineAdzenys Xr-Odt, Dyanavel XR, Evekeo · 2 products
- NicardipineCardene IV · 2 products
- Ketorolac tromethamineAcuvail, Sprix, Ketrolac Tromethamine · 1 product
- DigoxinLanoxin · 1 product
- KetoconazoleKetodan · 1 product
- Terbinafine hydrochloride1 product
- Butalbital, acetaminophen and caffeineFioricet · 1 product
- FlurbiprofenLurbiro · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| August 7, 2025 | ANDA219319 | Gabapentin GABAPENTIN | Pharmazone |
| July 17, 2023 | ANDA215377 | Nicardipine NICARDIPINE HYDROCHLORIDE | Pharmazone |
| March 15, 2023 | ANDA215787 | Diclofenac DICLOFENAC POTASSIUM | Pharmazone |
| April 7, 2022 | ANDA214088 | Butalbital and acetaminophen BUTALBITAL AND ACETAMINOPHEN | Pharmazone |
| March 23, 2022 | ANDA215788 | Ketorolac tromethamine KETOROLAC TROMETHAMINE | Pharmazone |
| March 11, 2022 | ANDA215209 | Digoxin DIGOXIN | Pangea |
| August 13, 2021 | ANDA214087 | Butalbital, acetaminophen and caffeine BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Pharmazone |
| March 30, 2021 | ANDA213827 | Metolazone METOLAZONE | Innogenix |
| May 22, 2020 | ANDA212901 | Amphetamine AMPHETAMINE SULFATE | Pharmazone |
| October 3, 2018 | ANDA208236 | Roflumilast ROFLUMILAST | Pharmazone |
| February 24, 2009 | ANDA077328 | Risperidone RISPERIDONE | Pharmazone |
| February 11, 2008 | ANDA077491 | Pravastatin sodium PRAVASTATIN SODIUM | Pharmazone |
| July 2, 2007 | ANDA076390 | Terbinafine hydrochloride TERBINAFINE HYDROCHLORIDE | Pharmazone |
| March 18, 2004 | ANDA076561 | Diclofenac CATAFLAM | Pangea |
| January 10, 2002 | ANDA075912 | Ketoconazole KETOCONAZOLE | Pharmazone |
| August 22, 2000 | ANDA075483 | Enalapril maleate ENALAPRIL MALEATE | Pharmazone |
| February 7, 2000 | ANDA075584 | Bupropion BUPROPION HYDROCHLORIDE | Pharmazone |
| March 30, 1998 | ANDA074823 | Terazosin hydrochloride TERAZOSIN HYDROCHLORIDE | Pharmazone |
| May 30, 1997 | ANDA074677 | Captopril CAPTOPRIL | Andas 5 Holding |
| January 4, 1995 | ANDA074447 | Flurbiprofen FLURBIPROFEN SODIUM | Bausch and Lomb |
| July 16, 1986 | ANDA070772 | Metronidazole METRONIDAZOLE | Innogenix |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
No recall of these products (by NDC code) appears in the FDA enforcement reports.
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