Drug company (FDA labeler)
Medsource Pharmaceuticals
NDC labeler code: 45865
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
- Trazodone hydrochlorideRaldesy Tm · 2 products
- GabapentinNeurontin, Gralise, Relgaabi · 2 products
- Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)Augmentin Es-600, Augmentin · 2 products
- Tramadol hydrochlorideConzip · 1 product
- CelecoxibCelebrex, Vyscoxa, Elyxyb - Celecoxib · 1 product
- Hydroxyzine1 product
- EsomeprazoleNexium · 1 product
- FluoxetineProzac · 1 product
- Etodolac1 product
- CarisoprodolSoma · 1 product
- Cyclobenzaprine hydrochlorideAmrix, Tonmya, Fexmid · 1 product
- Prednisone1 product
- Tramadol hydrochloride and acetaminophen1 product
- MethocarbamolRobaxin, Atmeksi, Tanlor · 1 product
- DiclofenacZipsor, Lofena, Cambia · 1 product
- NaproxenNaprelan, Rugby All Day Relief · 1 product
- AlprazolamXanax, Xanax XR · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| July 27, 2022 | ANDA212351 | Diclofenac DICLOFENAC SODIUM | Alembic |
| February 11, 2021 | ANDA208412 | Prednisone PREDNISONE | Strides Pharma |
| December 3, 2020 | ANDA205129 | Celecoxib CELECOXIB | Sciegen Pharms |
| February 21, 2020 | ANDA212517 | Naproxen NAPROXEN | Sciegen Pharms |
| May 14, 2018 | ANDA206943 | Gabapentin GABAPENTIN | Strides Pharma |
| October 10, 2017 | ANDA205253 | Trazodone hydrochloride TRAZODONE HYDROCHLORIDE | Zydus Pharms |
| March 22, 2017 | ANDA207152 | Tramadol hydrochloride and acetaminophen TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | Aurobindo Pharma |
| December 30, 2016 | ANDA204755 | Amoxicillin and clavulanate potassium (amoxicillin / clavulanate) AMOXICILLIN AND CLAVULANATE POTASSIUM | Micro Labs Ltd India |
| December 30, 2016 | ANDA205707 | Amoxicillin and clavulanate potassium (amoxicillin / clavulanate) AMOXICILLIN AND CLAVULANATE POTASSIUM | Micro Labs Ltd India |
| February 18, 2016 | ANDA204989 | Gabapentin RELGAABI | Sciegen Pharms |
| September 25, 2015 | ANDA078279 | Esomeprazole ESOMEPRAZOLE MAGNESIUM | DR Reddys |
| July 31, 2015 | ANDA203346 | Alprazolam ALPRAZOLAM | Aurobindo Pharma |
| March 16, 2015 | ANDA204597 | Fluoxetine FLUOXETINE HYDROCHLORIDE | Sciegen Pharms |
| August 20, 2014 | ANDA204279 | Hydroxyzine HYDROXYZINE HYDROCHLORIDE | Heritage |
| November 27, 2013 | ANDA202180 | Trazodone hydrochloride TRAZODONE HYDROCHLORIDE | Torrent |
| August 29, 2011 | ANDA200503 | Tramadol hydrochloride TRAMADOL HYDROCHLORIDE | Lupin Ltd |
| September 26, 2008 | ANDA078643 | Cyclobenzaprine hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE | Aurobindo Pharma |
| January 29, 2003 | ANDA040489 | Methocarbamol METHOCARBAMOL | Oxford Pharms |
| December 3, 2002 | ANDA076004 | Etodolac ETODOLAC | Apotex |
| March 7, 1997 | ANDA040188 | Carisoprodol CARISOPRODOL | Oxford Pharms |
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