Zolpidem Tartrate
- Product NDC
- 71610-254
- 11-digit product format
- 716100254
- Labeler code
- 71610
- Product ID
- 71610-254_3c965d39-7948-4e44-bd0c-62edb4501751
- 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
- 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
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 | 12.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WY6W63843K |
| Rxcui | 854880 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-254-30 | Zolpidem Tartrate | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-254 | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 1 package rows | 20190405_ebd6c66b-b230-48d7-b38f-d610b6cb2b6c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71610-254-30 | 71610025430 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-254-30) | 2019-03-22 | 0000-00-00 | No | No | Current |