Zolpidem
- Product NDC
- 71610-670
- 11-digit product format
- 716100670
- Labeler code
- 71610
- Product ID
- 71610-670_3613ad67-3a05-4718-8c94-ef4c72a58f12
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA077214
- Marketing category
- ANDA
- Marketing start
- 2020-09-24
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-670-30 | 71610067030 | 30 TABLET in 1 BOTTLE (71610-670-30) | 30 tablet | 2022-10-18 | No | No | Historical |
| 71610-670-53 | 71610067053 | 60 TABLET in 1 BOTTLE (71610-670-53) | 60 tablet | 2022-10-18 | No | No | Historical |
| 71610-670-60 | 71610067060 | 90 TABLET in 1 BOTTLE (71610-670-60) | 90 tablet | 2022-10-18 | No | No | Historical |
| 71610-670-70 | 71610067070 | 120 TABLET in 1 BOTTLE (71610-670-70) | 120 tablet | 2022-10-18 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Zolpidem | Aphena Pharma Solutions - Tennessee, LLC | 2022-10-18 | HUMAN PRESCRIPTION DRUG LABEL | 2 |