Zolpidem Tartrate
- Product NDC
- 71610-254
- 11-digit product format
- 716100254
- Labeler code
- 71610
- Product ID
- 71610-254_3c965d39-7948-4e44-bd0c-62edb4501751
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA204170
- Marketing category
- ANDA
- Marketing start
- 2017-05-15
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 12.5 mg/1
- Pharmacologic classes
- Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-254-30 | 71610025430 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-254-30) | 2019-03-22 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Zolpidem Tartrate | Aphena Pharma Solutions - Tennessee, LLC | 2019-03-02 | Human Prescription Drug Label | 1 |