Zolpidem
- Product NDC
- 63629-8999
- 11-digit product format
- 636298999
- Labeler code
- 63629
- Product ID
- 63629-8999_4157e8f6-e039-4ec4-b619-e787a32dc757
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA077214
- Marketing category
- ANDA
- Marketing start
- 2020-09-24
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 10 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zolpidem
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZOLPIDEM TARTRATE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WY6W63843K |
| Rxcui | 854873 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-8999-1 | 63629899901 | 30 TABLET in 1 BOTTLE (63629-8999-1) | 30 tablet | 2024-04-04 | 0000-00-00 | No | No | Current |
| 63629-8999-2 | 63629899902 | 60 TABLET in 1 BOTTLE (63629-8999-2) | 60 tablet | 2024-04-04 | 0000-00-00 | No | No | Current |
| 63629-8999-3 | 63629899903 | 90 TABLET in 1 BOTTLE (63629-8999-3) | 90 tablet | 2024-04-04 | 0000-00-00 | No | No | Current |