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
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 |
|---|
| 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 | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Zolpidem Tartrate | American Health Packaging | 2024-09-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |