Zolpidem Tartrate
- Product NDC
- 68788-8376
- 11-digit product format
- 687888376
- Labeler code
- 68788
- Product ID
- 68788-8376_fa1a688d-f773-4772-bf54-c1aed9ed8db1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA204170
- Marketing category
- ANDA
- Marketing start
- 2023-03-01
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 12.5 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
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 |
|---|
| 68788-8376-2 | Zolpidem Tartrate | 28 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 28 | | 3 |
| 68788-8376-3 | Zolpidem Tartrate | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 3 |
| 68788-8376-6 | Zolpidem Tartrate | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 3 |
| 68788-8376-9 | Zolpidem Tartrate | 90 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8376 | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.] | 2 | Current NDC, 4 package rows | 20240906_625fad5b-8817-4773-a2fc-20b662140e6e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8376-2 | 68788837602 | 28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-2) | 2023-03-01 | No | No | Current |
| 68788-8376-3 | 68788837603 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-3) | 2023-03-01 | No | No | Current |
| 68788-8376-6 | 68788837606 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-6) | 2023-03-01 | No | No | Current |
| 68788-8376-9 | 68788837609 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-9) | 2023-03-01 | No | No | Current |