Prescription drug · NDA
Ambien (zolpidem tartrate) NDC 0024-5401
Zolpidem tartrate 5 mg/1 · Tablet, Film coated · Oral · Sanofi-Aventis U.S. LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0024-5401-31 | 00024540131 | 100 TABLET, FILM COATED in 1 BOTTLE (0024-5401-31)Marketed from Apr 1, 1993 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Ambien
- Generic name (nonproprietary)
- zolpidem tartrate
- Active ingredients
- Zolpidem tartrate — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Sanofi-Aventis U.S. LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019908
- Marketing start
- Marketing end
- DEA schedule
- CIV
- Other FDA classes
- Central Nervous System Depression (Physiologic effect)GABA A Receptor Positive Modulators (Mechanism)
- Identifiers
- Product ID 0024-5401_3d6feaca-4f30-4ca9-a9c8-d9038744fa2fSPL ID 3d6feaca-4f30-4ca9-a9c8-d9038744fa2fSPL set ID c36cadf4-65a4-4466-b409-c82020b42452RxCUI 854873, 854875, 854876, 854878UNII WY6W63843K
- Pharmacologic class
- gamma-Aminobutyric Acid A Receptor Positive Modulator
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400024540131followed by a unit qualifier and the quantityPackage 00024-5401-31. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under NDA 019908
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ambienzolpidem tartrate | Zolpidem tartrate 10 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-5421 |
| Ambienzolpidem tartrate | Zolpidem tartrate 10 mg/1 | Tablet, Film coatedOral | Sanofi-Aventis U.S. LLC | 0024-5421 |
| Ambienzolpidem tartrate | Zolpidem tartrate 5 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-5401 |