Ambien
- Product NDC
- 0713-5421
- 11-digit product format
- 007135421
- Labeler code
- 0713
- Product ID
- 0713-5421_2d934208-e709-2948-e063-6294a90aa9b6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zolpidem tartrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- NDA019908
- Marketing category
- NDA
- Marketing start
- 2025-02-07
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ambien
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZOLPIDEM TARTRATE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WY6W63843K |
| Rxcui | 854873, 854875, 854876, 854878 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0713-5421-01 | Ambien | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0713-5421 | AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [COSETTE PHARMACEUTICALS, INC.] | 1 | Current NDC, 1 package rows | 20250210_747949c5-2c91-4909-8a07-71b6826f8e97.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0713-5421-01 | 00713542101 | 100 TABLET, FILM COATED in 1 BOTTLE (0713-5421-01) | 2025-02-07 | No | No | Current |