Drug company (FDA labeler)
Alvogen Inc.
NDC labeler code: 47781
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
- LevothyroxineTirosint, Tirosint Sol, Synthroid · 14 products
- Hydrocodone bitartrateHysingla ER · 13 products
- Lisdexamfetamine dimesylateVyvanse, Arynta · 7 products
- LenalidomideRevlimid · 6 products
- Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfateAdderall, Mixed Salts of a Single Entity Amphetamine Product XR, Adderall XR · 5 products
- Oseltamivir phosphateTamiflu · 4 products
- Buprenorphine and naloxoneZubsolv, Buprenorphine and Naloxone Sublingual Film, Suboxone · 4 products
- BuprenorphineBelbuca, Brixadi, Buprenorphine Transdermal System · 4 products
- Oxycodone and acetaminophenEndocet, Prolate, Percocet · 3 products
- Oxycodone hydrochlorideOxycontin, Roxybond, Roxicodone · 3 products
- NaproxenNaprelan, Rugby All Day Relief · 2 products
- RasagilineAzilect · 2 products
- TeriparatideForteo, Bonsity · 2 products
- Sertraline hydrochlorideZoloft · 2 products
- Testosterone cypionateDepo-Testosterone, Azmiro · 2 products
- DexamethasoneTaperdex 6-Day, Hemady, Taperdex 12-Day · 2 products
- Pyridostigmine bromideMestinon, Pryidostigmine Bromide, Regonol · 1 product
- Nitrofurantoin (monohydrate/macrocrystals)Macrobid, Nitrofurantoin Monohydrate Macrocrystalline, Nitrofurantoin Mono · 1 product
- Methenamine hippurate1 product
- Disulfiram1 product
- EstradiolEstradiol Vaginal, Dotti, Estradiol Transdermal System · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| August 25, 2023 | ANDA214547 | Lisdexamfetamine dimesylate LISDEXAMFETAMINE DIMESYLATE | Norwich |
| August 31, 2022 | ANDA210480 | Lenalidomide LENALIDOMIDE | Alvogen |
| May 17, 2022 | ANDA207490 | Buprenorphine BUPRENORPHINE | Strides Pharma Intl |
| October 4, 2021 | NDA215133 | Sertraline hydrochloride SERTRALINE HYDROCHLORIDE | Almatica |
| March 1, 2021 | ANDA208269 | Hydrocodone bitartrate HYDROCODONE BITARTRATE | Alvogen |
| January 21, 2020 | ANDA206986 | Hydrocodone bitartrate HYDROCODONE BITARTRATE | Alvogen |
| October 4, 2019 | NDA211939 | Teriparatide BONSITY | Alvogen |
| January 24, 2019 | ANDA205954 | Buprenorphine and naloxone BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | Alvogen |
| March 5, 2018 | ANDA209767 | Estradiol ESTRADIOL | Encube |
| October 31, 2017 | ANDA208823 | Oseltamivir phosphate OSELTAMIVIR PHOSPHATE | Alvogen |
| July 28, 2017 | ANDA207388 | Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | Alvogen |
| June 16, 2017 | ANDA207742 | Testosterone cypionate TESTOSTERONE CYPIONATE | Am Regent |
| August 3, 2016 | ANDA202595 | Oseltamivir phosphate OSELTAMIVIR PHOSPHATE | Natco |
| March 15, 2016 | ANDA201970 | Rasagiline RASAGILINE MESYLATE | Orbion Pharms |
| June 26, 2015 | ANDA204737 | Pyridostigmine bromide PYRIDOSTIGMINE BROMIDE | Alvogen |
| August 8, 2013 | ANDA091681 | Disulfiram DISULFIRAM | Alvogen |
| July 26, 2012 | ANDA202677 | Oxycodone and acetaminophen OXYCODONE AND ACETAMINOPHEN | Alvogen |
| December 30, 2011 | ANDA202116 | Oxycodone hydrochloride OXYCODONE HYDROCHLORIDE | Alvogen |
| October 24, 2002 | NDA021116 | Levothyroxine THYRO-TABS | Alvogen |
| January 5, 1996 | NDA020353 | Naproxen NAPRELAN | Twi Pharms |
| December 24, 1991 | NDA020064 | Nitrofurantoin (monohydrate/macrocrystals) MACROBID | Almatica |
| December 15, 1983 | ANDA088481 | Dexamethasone DEXAMETHASONE | Alvogen |
| July 5, 1967 | NDA016151 | Methenamine hippurate UREX | Quagen |
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.
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
- All drug companiesA to Z
- 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