Zolpidem Tartrate
- Product NDC
- 68788-8376
- 11-digit product format
- 687888376
- Labeler code
- 68788
- Product ID
- 68788-8376_fa1a688d-f773-4772-bf54-c1aed9ed8db1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA204170
- Marketing category
- ANDA
- Marketing start
- 2023-03-01
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 12.5 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8376-2 | 68788837602 | 28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-2) | 2023-03-01 | No | No | Historical |
| 68788-8376-3 | 68788837603 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-3) | 2023-03-01 | No | No | Historical |
| 68788-8376-6 | 68788837606 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-6) | 2023-03-01 | No | No | Historical |
| 68788-8376-9 | 68788837609 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-9) | 2023-03-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Zolpidem Tartrate | Preferred Pharmaceuticals Inc. | 2025-10-08 | HUMAN PRESCRIPTION DRUG LABEL | 3 |
| Zolpidem Tartrate | Preferred Pharmaceuticals Inc. | 2024-09-04 | HUMAN PRESCRIPTION DRUG LABEL | 2 |