Zolpidem Tartrate
- Product NDC
- 63187-862
- 11-digit product format
- 631870862
- Labeler code
- 63187
- Product ID
- 63187-862_16ffd293-15a1-4014-9b06-6772decd7651
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zolpidem tartrate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- NDA021774
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2010-12-06
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 12.5 mg/1
- Pharmacologic classes
- Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [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 |
|---|
| 63187-862-15 | 63187086215 | 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-862-15) | 2017-06-01 | No | No | Historical |
| 63187-862-30 | 63187086230 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-862-30) | 2017-06-01 | No | No | Historical |
| 63187-862-60 | 63187086260 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-862-60) | 2017-06-01 | No | No | Historical |
| 63187-862-90 | 63187086290 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-862-90) | 2017-06-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Zolpidem Tartrate | Proficient Rx LP | 2019-11-01 | HUMAN PRESCRIPTION DRUG LABEL | 3 |