Zolpidem Tartrate
- Product NDC
- 47335-307
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA204170
- Marketing category
- ANDA
- Substance
- ZOLPIDEM TARTRATE
- Current FDA listing
- Yes
Related Records
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|---|---|---|---|---|
| 47335-307-13 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-307-13) | 2017-05-15 | No | Historical | |
| 47335-307-88 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-307-88) | 2017-05-15 | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|---|---|---|---|
| These highlights do not include all the information needed to use ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS. ZOLPIDEM TARTRATE extended-release tablets, for oral use, C-IV Initial U.S. Approval: 1992 | Aphena Pharma Solutions - Tennessee, LLC | 2025-06-09 | Human Prescription Drug Label | 1 |
| These highlights do not include all the information needed to use ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS. ZOLPIDEM TARTRATE extended-release tablets, for oral use, C-IV Initial U.S. Approval: 1992 | Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited | 2023-10-18 | Human Prescription Drug Label | 13 |