NDC product
Hydrocodone Bitartrate and Homatropine Methylbromide
NDC 0121-1036 · PAI Holdings, LLC dba PAI Pharma
Key facts
| Product NDC | 0121-1036 |
|---|---|
| Proprietary name | Hydrocodone Bitartrate and Homatropine Methylbromide |
| Nonproprietary name | Hydrocodone Bitartrate and Homatropine Methylbromide |
| Substances | HYDROCODONE BITARTRATE, HOMATROPINE METHYLBROMIDE |
| Dosage form | SOLUTION |
| Route | ORAL |
| Labeler | PAI Holdings, LLC dba PAI Pharma |
| Product type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Application number | NDA005213 |
| DEA schedule | CII |
| Pharmacologic classes | Opioid Agonist [EPC], Opioid Agonists [MoA] |
| Marketing start | Aug 5, 2024 |
| 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: