Zolpidem
- Product NDC
- 63629-9613
- 11-digit product format
- 636299613
- Labeler code
- 63629
- Product ID
- 63629-9613_e5e05dd8-d19e-4562-9ea1-f02b02ea6407
- 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
- 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
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 |
|---|
| 63629-9613-1 | 63629961301 | 1000 TABLET in 1 BOTTLE (63629-9613-1) | 1000 tablet | 2023-02-03 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Zolpidem | Bryant Ranch Prepack | 2024-04-05 | HUMAN PRESCRIPTION DRUG LABEL | 103 |