Zolpidem Tartrate
- Product NDC
- 47335-308
- 11-digit product format
- 473350308
- Labeler code
- 47335
- Product ID
- 47335-308_4a5c474b-e752-4d01-be37-a66e7c9bf62e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- 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, 854894 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47335-308-13 | Zolpidem Tartrate | 500 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 500 | | 13 |
| 47335-308-88 | Zolpidem Tartrate | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-308 | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 13 | Current NDC, Legacy NDC, 2 package rows | 20231026_0c64bc71-2e7f-4b15-a8e1-acb8de04395f.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 |
|---|
| 47335-308-13 | 47335030813 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-308-13) | 2017-05-15 | 0000-00-00 | No | No | Current |
| 47335-308-88 | 47335030888 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-308-88) | 2017-05-15 | 0000-00-00 | No | No | Current |