Zolpidem Tartrate
- Product NDC
- 71610-913
- 11-digit product format
- 716100913
- Labeler code
- 71610
- Product ID
- 71610-913_8a13a4cc-3230-4119-9b8c-02fde0298d45
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA204170
- Marketing category
- ANDA
- Marketing start
- 2017-05-15
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 6.25 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zolpidem Tartrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZOLPIDEM TARTRATE | 6.25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WY6W63843K |
| Rxcui | 854894 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-913-30 | Zolpidem Tartrate | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 1 |
| 71610-913-53 | Zolpidem Tartrate | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 1 |
| 71610-913-60 | Zolpidem Tartrate | 90 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 90 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-913-30 | 71610091330 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-913-30) | 2025-06-05 | No | No | Current |
| 71610-913-53 | 71610091353 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-913-53) | 2025-06-05 | No | No | Current |
| 71610-913-60 | 71610091360 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-913-60) | 2025-06-05 | No | No | Current |