NDC product
buprenorphine hydrochloride
NDC 0121-2038 · PAI Holdings, LLC dba PAI Pharma
Key facts
| Product NDC | 0121-2038 |
|---|---|
| Proprietary name | buprenorphine hydrochloride |
| Nonproprietary name | buprenorphine hydrochloride |
| Substances | BUPRENORPHINE HYDROCHLORIDE |
| Dosage form | TABLET |
| Route | SUBLINGUAL |
| Labeler | PAI Holdings, LLC dba PAI Pharma |
| Product type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Application number | ANDA090622 |
| DEA schedule | CIII |
| Pharmacologic classes | Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA] |
| Marketing start | Oct 12, 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: