NDC product
Buprenorphine and Naloxone
NDC 0121-1018 · PAI Holdings, LLC dba PAI Pharma
Key facts
| Product NDC | 0121-1018 |
|---|---|
| Proprietary name | Buprenorphine and Naloxone |
| Nonproprietary name | buprenorphine hydrochloride and naloxone hydrochloride |
| Substances | BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE |
| Dosage form | TABLET |
| Route | SUBLINGUAL |
| Labeler | PAI Holdings, LLC dba PAI Pharma |
| Product type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Application number | ANDA204431 |
| DEA schedule | CIII |
| Pharmacologic classes | Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA] |
| Marketing start | Sep 5, 2023 |
| Listing certified through | Dec 31, 2027 |
At a glance
- 1–9 Package NDCs
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About National Drug Codes (NDC)
The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.
Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date: