ZOLPIDEM TARTRATE
- Product NDC
- 71610-839
- 11-digit product format
- 716100839
- Labeler code
- 71610
- Product ID
- 71610-839_1a8a808c-982f-49a8-e063-6294a90aa348
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA078970
- Marketing category
- ANDA
- Marketing start
- 2014-04-11
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 6.25 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-839-30 | 71610083930 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-839-30) | 2024-06-04 | No | No | Historical |
| 71610-839-53 | 71610083953 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-839-53) | 2024-06-04 | No | No | Historical |
| 71610-839-60 | 71610083960 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-839-60) | 2024-06-04 | No | No | Historical |
| 71610-839-80 | 71610083980 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-839-80) | 2024-06-04 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| ZOLPIDEM TARTRATE | Aphena Pharma Solutions - Tennessee, LLC | 2024-06-10 | HUMAN PRESCRIPTION DRUG LABEL | 1 |