FDA NDC Directory · JSON-LD · Markdown
NDC 65162-415 · HUMAN PRESCRIPTION DRUG · TABLET
| Generic name | Buprenorphine and Naloxone |
|---|---|
| Labeler / Manufacturer | Amneal Pharmaceuticals LLC |
| Marketing category | Abbreviated NDA (generic) · App ANDA203136 |
| Dosage form / route | TABLET · SUBLINGUAL |
| Active ingredients | BUPRENORPHINE HYDROCHLORIDE (8 mg/1) NALOXONE HYDROCHLORIDE DIHYDRATE (2 mg/1) |
| Marketing started | 20130222 |
| Package count | 2 |
Source: openFDA. Public-domain (CC0).