Zolpidem Tartrate
- Product NDC
- 80425-0061
- 11-digit product format
- 804250061
- Labeler code
- 80425
- Product ID
- 80425-0061_2a98ff70-0363-7169-e063-6394a90adc74
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA078413
- Marketing category
- ANDA
- Marketing start
- 2007-05-04
- 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
- Zolpidem Tartrate
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0061-1 | Zolpidem Tartrate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 7 |
| 80425-0061-2 | Zolpidem Tartrate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 7 |
| 80425-0061-3 | Zolpidem Tartrate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0061 | ZOLPIDEM TARTRATE TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC] | 7 | Current NDC, Legacy NDC, 3 package rows | 20250101_af87df4e-2c97-e23e-e053-2a95a90ab354.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 80425-0061-1 | 80425006101 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0061-1) | 2007-05-04 | 0000-00-00 | No | No | Current |
| 80425-0061-2 | 80425006102 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0061-2) | 2007-05-04 | 0000-00-00 | No | No | Current |
| 80425-0061-3 | 80425006103 | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0061-3) | 2007-05-04 | 0000-00-00 | No | No | Current |