Zolpidem Tartrate
- Product NDC
- 68071-3482
- 11-digit product format
- 680713482
- Labeler code
- 68071
- Product ID
- 68071-3482_2ad45778-ef3b-9f3e-e063-6394a90a5255
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA078413
- Marketing category
- ANDA
- Marketing start
- 2007-05-04
- 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
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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WY6W63843K |
| Rxcui | 854876 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3482-2 | Zolpidem Tartrate | 2 in 1 BOTTLE | TABLET, FILM COATED | 2 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3482 | ZOLPIDEM TARTRATE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 2 | Current NDC, 1 package rows | 20250105_03207c75-f680-c18a-e063-6294a90afaa1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3482-2 | 68071348202 | 2 TABLET, FILM COATED in 1 BOTTLE (68071-3482-2) | 2023-08-17 | No | No | Historical |