Drug company (FDA labeler)
Amphastar Pharmaceuticals, Inc.
NDC labeler code: 0548
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
- Enoxaparin sodiumLovenox · 8 products
- Isoproterenol hydrochloride2 products
- Neostigmine methylsulfateBloxiverz · 2 products
- Medroxyprogesterone acetateProvera, Depo-Provera, Depo-Subq Provera · 2 products
- GlucagonBaqsimi, Gvoke Hypopen 1 Mg Auto-Injector, Gvoke Pfs 1 Mg Pre-Filled Syringe · 2 products
- Vasopressin1 product
- TeriparatideForteo, Bonsity · 1 product
- Ganirelix acetateFyremadel · 1 product
- CosyntropinCortrosyn · 1 product
- HyaluronidaseAmphadase · 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.
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| December 12, 2025 | ANDA213641 | Teriparatide TERIPARATIDE | Amphastar Pharms Inc |
| July 18, 2022 | ANDA211857 | Vasopressin VASOPRESSIN | Amphastar Pharms Inc |
| April 7, 2022 | ANDA212613 | Ganirelix acetate GANIRELIX ACETATE | Amphastar Pharms Inc |
| July 24, 2019 | NDA210134 | Glucagon BAQSIMI | Amphastar Pharms Inc |
| March 14, 2019 | ANDA208600 | Enoxaparin sodium ENOXAPARIN SODIUM | Amphastar Pharms Inc |
| June 18, 2018 | ANDA210106 | Isoproterenol hydrochloride ISOPROTERENOL HYDROCHLORIDE | Amphastar Pharms Inc |
| November 28, 2017 | ANDA077235 | Medroxyprogesterone acetate MEDROXYPROGESTERONE ACETATE | Amphastar Pharms Inc |
| November 28, 2017 | ANDA077334 | Medroxyprogesterone acetate MEDROXYPROGESTERONE ACETATE | Amphastar Pharms Inc |
| September 25, 2017 | ANDA209933 | Neostigmine methylsulfate NEOSTIGMINE METHYLSULFATE | Amphastar Pharms Inc |
| September 19, 2011 | ANDA076684 | Enoxaparin sodium ENOXAPARIN SODIUM (PRESERVATIVE FREE) | Amphastar Pharm |
| October 26, 2004 | BLA021665 | Hyaluronidase AMPHADASE | Amphastar Pharm |
| April 22, 1970 | NDA016750 | Cosyntropin CORTROSYN | Amphastar Pharms Inc |
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
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- 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