Zolpidem Tartrate
- Product NDC
- 72162-2441
- 11-digit product format
- 721622441
- Labeler code
- 72162
- Product ID
- 72162-2441_5648ce94-ab6e-40c5-a40e-fa90d79e3c89
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA204170
- Marketing category
- ANDA
- Marketing start
- 2017-05-15
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zolpidem Tartrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZOLPIDEM TARTRATE | 12.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WY6W63843K |
| Rxcui | 854880 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72162-2441-1 | 72162244101 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72162-2441-1) | 2025-01-15 | No | No | Historical |
| 72162-2441-3 | 72162244103 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72162-2441-3) | 2025-01-15 | No | No | Historical |