Zolpidem Tartrate
- Product NDC
- 80425-0322
- 11-digit product format
- 804250322
- Labeler code
- 80425
- Product ID
- 80425-0322_2a9bfe6a-6d6f-b262-e063-6294a90a1cf3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA077903
- Marketing category
- ANDA
- Marketing start
- 2007-09-05
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| WY6W63843K | ZOLPIDEM TARTRATE | 99294-93-6 | ZOLPIDEM TARTRATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0322-1 | 80425032201 | 30 TABLET in 1 BOTTLE (80425-0322-1) | 30 tablet | 2023-04-13 | No | No | Historical |
| 80425-0322-2 | 80425032202 | 60 TABLET in 1 BOTTLE (80425-0322-2) | 60 tablet | 2023-04-13 | No | No | Historical |
| 80425-0322-3 | 80425032203 | 90 TABLET in 1 BOTTLE (80425-0322-3) | 90 tablet | 2023-04-13 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Zolpidem Tartrate Tablets | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL | 2 |