ZOLPIDEM TARTRATE
- Product NDC
- 71610-904
- 11-digit product format
- 716100904
- Labeler code
- 71610
- Product ID
- 71610-904_35d0e953-2920-f36b-e063-6294a90a7d52
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zolpidem tartrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA077214
- Marketing category
- ANDA
- Marketing start
- 2007-04-23
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-904-10 | 71610090410 | 10 TABLET, FILM COATED in 1 BOTTLE (71610-904-10) | 2025-05-06 | No | No | Historical |
| 71610-904-14 | 71610090414 | 14 TABLET, FILM COATED in 1 BOTTLE (71610-904-14) | 2025-05-06 | No | No | Historical |
| 71610-904-15 | 71610090415 | 15 TABLET, FILM COATED in 1 BOTTLE (71610-904-15) | 2025-05-06 | No | No | Historical |
| 71610-904-20 | 71610090420 | 20 TABLET, FILM COATED in 1 BOTTLE (71610-904-20) | 2025-05-13 | No | No | Historical |
| 71610-904-28 | 71610090428 | 28 TABLET, FILM COATED in 1 BOTTLE (71610-904-28) | 2025-05-06 | No | No | Historical |
| 71610-904-30 | 71610090430 | 30 TABLET, FILM COATED in 1 BOTTLE (71610-904-30) | 2025-05-06 | No | No | Historical |
| 71610-904-45 | 71610090445 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-904-45) | 2025-05-06 | No | No | Historical |
| 71610-904-53 | 71610090453 | 60 TABLET, FILM COATED in 1 BOTTLE (71610-904-53) | 2025-05-06 | No | No | Historical |
| 71610-904-60 | 71610090460 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-904-60) | 2025-05-06 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| ZOLPIDEM TARTRATE | Aphena Pharma Solutions - Tennessee, LLC | 2025-05-23 | HUMAN PRESCRIPTION DRUG LABEL | 3 |