Zolpidem Tartrate
- Product NDC
- 80425-0513
- 11-digit product format
- 804250513
- Labeler code
- 80425
- Product ID
- 80425-0513_3310d645-9b5f-16f5-e063-6294a90a9eb5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA077322
- Marketing category
- ANDA
- Marketing start
- 2025-04-15
- 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 |
|---|
| 80425-0513-1 | Zolpidem Tartrate | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 1 |
| 80425-0513-2 | Zolpidem Tartrate | 60 in 1 BOTTLE | TABLET, COATED | 60 | | 1 |
| 80425-0513-3 | Zolpidem Tartrate | 90 in 1 BOTTLE | TABLET, COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0513 | ZOLPIDEM TARTRATE TABLET, COATED [ADVANCED RX OF TENNESSEE, LLC] | 1 | Current NDC, 3 package rows | 20250419_3310d63e-d79a-175d-e063-6394a90a4270.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0513-1 | 80425051301 | 30 TABLET, COATED in 1 BOTTLE (80425-0513-1) | 2025-04-15 | No | No | Historical |
| 80425-0513-2 | 80425051302 | 60 TABLET, COATED in 1 BOTTLE (80425-0513-2) | 2025-04-15 | No | No | Historical |
| 80425-0513-3 | 80425051303 | 90 TABLET, COATED in 1 BOTTLE (80425-0513-3) | 2025-04-15 | No | No | Historical |