NDC product
Promethazine DM
NDC 0121-1070 · PAI Holdings, LLC dba PAI Pharma
Key facts
| Product NDC | 0121-1070 |
|---|---|
| Proprietary name | Promethazine DM |
| Nonproprietary name | Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
| Substances | DEXTROMETHORPHAN HYDROBROMIDE, PROMETHAZINE HYDROCHLORIDE |
| Dosage form | SOLUTION |
| Route | ORAL |
| Labeler | PAI Holdings, LLC dba PAI Pharma |
| Product type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Application number | ANDA040649 |
| Pharmacologic classes | Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
| Marketing start | Jun 4, 2025 |
| Listing certified through | Dec 31, 2026 |
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: