ZOLPIDEM TARTRATE
- Product NDC
- 71205-286
- 11-digit product format
- 712050286
- Labeler code
- 71205
- Product ID
- 71205-286_bde02c60-5382-4505-b806-ddb2f5f9deab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA078970
- Marketing category
- ANDA
- Marketing start
- 2014-04-11
- 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 |
|---|
| 71205-286-30 | 71205028630 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-286-30) | 2019-06-21 | No | No | Historical |
| 71205-286-60 | 71205028660 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-286-60) | 2019-06-21 | No | No | Historical |
| 71205-286-90 | 71205028690 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-286-90) | 2019-06-21 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| ZOLPIDEM TARTRATE | Proficient Rx LP | 2022-11-01 | HUMAN PRESCRIPTION DRUG LABEL | 2 |