Drug company (FDA labeler)
Doc Rx
NDC labeler code: 69306
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
- DexamethasoneTaperdex 6-Day, Hemady, Taperdex 12-Day · 3 products
- Cyclobenzaprine hydrochlorideAmrix, Tonmya, Fexmid · 2 products
- Metaxalone2 products
- MethocarbamolRobaxin, Atmeksi, Tanlor · 2 products
- DiclofenacZipsor, Lofena, Cambia · 1 product
- AzithromycinZithromax, Azasite · 1 product
- Etodolac1 product
- Ibuprofen and famotidine1 product
- MethylprednisoloneSolu-Medrol, Medrol · 1 product
- Naproxen and esomeprazole magnesium1 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 |
|---|---|---|---|
| March 15, 2023 | ANDA215787 | Diclofenac DICLOFENAC POTASSIUM | Pharmazone |
| August 3, 2021 | ANDA211890 | Ibuprofen and famotidine IBUPROFEN AND FAMOTIDINE | Alkem Labs Ltd |
| February 18, 2020 | ANDA204206 | Naproxen and esomeprazole magnesium NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | DR Reddys |
| February 26, 2019 | ANDA210000 | Azithromycin AZITHROMYCIN | Bionpharma |
| June 7, 2018 | ANDA208834 | Etodolac ETODOLAC | Amneal Pharms Co |
| May 14, 2018 | ANDA204072 | Methylprednisolone METHYLPREDNISOLONE | Tianjin Tianyao |
| June 15, 2017 | ANDA203695 | Metaxalone METAXALONE | Actavis Labs Fl Inc |
| November 22, 2016 | ANDA204770 | Metaxalone METAXALONE | Lannett Co Inc |
| February 1, 2007 | NDA021777 | Cyclobenzaprine hydrochloride AMRIX | Teva Pharms Intl |
| April 19, 2006 | ANDA077563 | Cyclobenzaprine hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE | Jubilant Cadista |
| January 29, 2003 | ANDA040489 | Methocarbamol METHOCARBAMOL | Oxford Pharms |
| July 19, 1978 | ANDA084612 | Dexamethasone DEXAMETHASONE | Hikma |
| — | ANDA087916 | Dexamethasone | — |
| — | ANDA088306 | Dexamethasone | — |
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