NDC product
Promethazine Hydrochloride and Dextromethorphan Hydrobromide
NDC 0713-0780 · Cosette Pharmaceuticals, Inc.
Key facts
| Product NDC | 0713-0780 |
|---|---|
| Proprietary name | Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
| Nonproprietary name | Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
| Substances | PROMETHAZINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE |
| Dosage form | SOLUTION |
| Route | ORAL |
| Labeler | Cosette Pharmaceuticals, Inc. |
| Product type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Application number | ANDA091687 |
| 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 | Sep 19, 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: