NDC product
Ambien CR
NDC 0713-5521 · Cosette Pharmaceuticals, Inc.
Key facts
| Product NDC | 0713-5521 |
|---|---|
| Proprietary name | Ambien |
| Nonproprietary name | zolpidem tartrate |
| Substances | ZOLPIDEM TARTRATE |
| Dosage form | TABLET, COATED |
| Route | ORAL |
| Labeler | Cosette Pharmaceuticals, Inc. |
| Product type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Application number | NDA021774 |
| DEA schedule | CIV |
| Pharmacologic classes | Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC] |
| Marketing start | Feb 7, 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: