Drug company (FDA labeler)
PharmPak, Inc.
NDC labeler code: 54348
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
- IbuprofenIbu, Caldolor · 3 products
- EstradiolEstradiol Vaginal, Dotti, Estradiol Transdermal System · 2 products
- MetronidazoleMetronidazole Vaginal, Metronidazole Vaginal Gel, Likmez · 2 products
- CiprofloxacinCiprofloxacin in Dextrose, Cipro, Ciloxan · 2 products
- AcyclovirZovirax, Avaclyr · 2 products
- Ondansetron2 products
- Prednisone1 product
- Medroxyprogesterone acetateProvera, Depo-Provera, Depo-Subq Provera · 1 product
- ProchlorperazineCompro · 1 product
- MisoprostolCytotec · 1 product
- AzithromycinZithromax, Azasite · 1 product
- LorazepamAtivan, Loreev XR · 1 product
- Promethazine hydrochloridePhenergan, Promethegan · 1 product
- Nitrofurantoin (monohydrate/macrocrystals)Macrobid, Nitrofurantoin Monohydrate Macrocrystalline, Nitrofurantoin Mono · 1 product
- SpironolactoneAldactone · 1 product
- Sulfamethoxazole and trimethoprimSulfamethoxazole and Trimethoprim Ds, Sulfatrim, Bactrim Ds · 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 |
|---|---|---|---|
| September 15, 2015 | ANDA091625 | Ibuprofen IBUPROFEN | Granules |
| January 22, 2014 | ANDA203458 | Metronidazole METRONIDAZOLE | Unichem |
| October 29, 2013 | ANDA203834 | Acyclovir ACYCLOVIR | Hetero Labs Ltd V |
| July 25, 2012 | ANDA091667 | Misoprostol MISOPROSTOL | Novel Labs Inc |
| July 2, 2010 | ANDA091426 | Spironolactone SPIRONOLACTONE | Amneal Pharms |
| July 31, 2007 | ANDA078539 | Ondansetron ONDANSETRON HYDROCHLORIDE | Aurobindo Pharma |
| July 30, 2007 | ANDA078203 | Lorazepam LORAZEPAM | Leading |
| July 31, 2006 | ANDA040712 | Promethazine hydrochloride PROMETHAZINE HYDROCHLORIDE | Kvk Tech |
| November 14, 2005 | ANDA065225 | Azithromycin AZITHROMYCIN | Pliva |
| January 27, 2005 | ANDA076899 | Sulfamethoxazole and trimethoprim SULFAMETHOXAZOLE AND TRIMETHOPRIM | Amneal Pharms Ny |
| September 10, 2004 | ANDA076639 | Ciprofloxacin CIPROFLOXACIN HYDROCHLORIDE | Unique |
| February 27, 1998 | ANDA040268 | Prochlorperazine PROCOMP | Jubilant Cadista |
| October 22, 1997 | ANDA040197 | Estradiol ESTRADIOL | Barr Labs Inc |
| August 9, 1996 | ANDA040159 | Medroxyprogesterone acetate MEDROXYPROGESTERONE ACETATE | Barr |
| December 24, 1991 | NDA020064 | Nitrofurantoin (monohydrate/macrocrystals) MACROBID | Almatica |
| January 17, 1972 | ANDA080356 | Prednisone PREDNISONE | Watson Labs |
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