Prescription drug · NDA
Ambien (zolpidem tartrate) NDC 0713-5401
Zolpidem tartrate 5 mg/1 · Tablet, Film coated · Oral · Cosette Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0713-5401-01 | 00713540101 | 100 TABLET, FILM COATED in 1 BOTTLE (0713-5401-01)Marketed from Feb 7, 2025 |
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
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019908
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Central Nervous System Depression (Physiologic effect)GABA A Receptor Positive Modulators (Mechanism)
- Identifiers
- Product ID 0713-5401_2d934208-e709-2948-e063-6294a90aa9b6SPL ID 2d934208-e709-2948-e063-6294a90aa9b6SPL set ID 747949c5-2c91-4909-8a07-71b6826f8e97RxCUI 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
N400713540101followed by a unit qualifier and the quantityPackage 00713-5401-01. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
AMBIEN (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. AMBIEN has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14) ] . The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. AMBIEN, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. ( 1 )
Excerpt only. Read the full label for complete information.
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 5 mg/1 | Tablet, Film coatedOral | Sanofi-Aventis U.S. LLC | 0024-5401 |
| Ambienzolpidem tartrate | Zolpidem tartrate 10 mg/1 | Tablet, Film coatedOral | Sanofi-Aventis U.S. LLC | 0024-5421 |