zolpidem tartrate
- Product NDC
- 52427-775
- 11-digit product format
- 524270775
- Labeler code
- 52427
- Product ID
- 52427-775_1de7823f-3d49-f5ef-f98b-6d34d2419dae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zolpidem tartrate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Almatica Pharma LLC
- Application
- NDA215721
- Marketing category
- NDA
- Marketing start
- 2023-05-09
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 7.5 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 | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WY6W63843K |
| Rxcui | 2637353 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52427-775-30 | zolpidem tartrate | 30 in 1 BOTTLE | CAPSULE | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52427-775 | ZOLPIDEM TARTRATE CAPSULE [ALMATICA PHARMA LLC] | 2 | Current NDC, 1 package rows | 20241016_2f1a3600-9bd6-3651-3ab5-1e4e0b0a3916.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 |
|---|
| 52427-775-30 | 52427077530 | 30 CAPSULE in 1 BOTTLE (52427-775-30) | 30 capsule | 2023-05-24 | No | No | Current |