Zolpidem Tartrate
- Product NDC
- 60687-838
- 11-digit product format
- 606870838
- Labeler code
- 60687
- Product ID
- 60687-838_2035bfab-4917-0e91-e063-6294a90a7b22
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA078413
- Marketing category
- ANDA
- Marketing start
- 2024-09-01
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 5 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
- Zolpidem Tartrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZOLPIDEM TARTRATE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WY6W63843K |
| Rxcui | 854876 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60687-838-01 | Zolpidem Tartrate | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 1 |
| 60687-838-11 | Zolpidem Tartrate | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-838 | ZOLPIDEM TARTRATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | Current NDC, 2 package rows | 20240906_eb850154-4b4b-4d9a-8476-aea1a93fe8d7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60687-838-01 | 60687083801 | 100 BLISTER PACK in 1 CARTON (60687-838-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-838-11) | 100 blister pack | 2024-09-01 | No | No | Current |
| 60687-838-11 | 60687083811 | 1 in 1 BLISTER PACK | | | | | Historical |