ZOLPIDEM TARTRATE
- Product NDC
- 68788-8654
- 11-digit product format
- 687888654
- Labeler code
- 68788
- Product ID
- 68788-8654_542b2687-71b1-4b46-bf3c-c3f28bfaa724
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA078970
- Marketing category
- ANDA
- Marketing start
- 2024-05-09
- 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
openFDA Listing Details
- Product ID
- 68788-8654_542b2687-71b1-4b46-bf3c-c3f28bfaa724
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- ZOLPIDEM TARTRATE
- Generic name
- Zolpidem Tartrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing start
- 2024-05-09
- Marketing category
- ANDA
- Application number
- ANDA078970
- Pharmacologic classes
- Central Nervous System Depression [PE]; GABA A Receptor Positive Modulators [MoA]; gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
- DEA schedule
- CIV
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| ZOLPIDEM TARTRATE | 6.25 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | WY6W63843K |
| Rxcui | 854894 |
| Spl Set Id | 76ff87e4-3aa2-439d-8436-d9e6affb33c8 |
| Manufacturer Name | Preferred Pharmaceuticals Inc. |
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 |
|---|
| 68788-8654-3 | 68788865403 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8654-3) | 2024-05-09 | No | No | Current |
| 68788-8654-6 | 68788865406 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8654-6) | 2024-05-09 | No | No | Current |
| 68788-8654-9 | 68788865409 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8654-9) | 2024-05-09 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| ZOLPIDEM TARTRATE | Preferred Pharmaceuticals Inc. | 2025-10-08 | HUMAN PRESCRIPTION DRUG LABEL | 2 |