Zolpidem Tartrate
- Product NDC
- 76420-494
- 11-digit product format
- 764200494
- Labeler code
- 76420
- Product ID
- 76420-494_ea435212-caf8-164b-e053-2a95a90a0bf6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA213592
- Marketing category
- ANDA
- Marketing start
- 2020-12-17
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 6.25 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 | 6.25 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 |
|---|
| 76420-494-01 | Zolpidem Tartrate | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 1 |
| 76420-494-30 | Zolpidem Tartrate | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 1 |
| 76420-494-60 | Zolpidem Tartrate | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 1 |
| 76420-494-90 | Zolpidem Tartrate | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-494 | ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [ASCLEMED USA, INC.] | 1 | Current NDC, Legacy NDC, 4 package rows | 20221006_35f6c1ab-a61c-4625-b932-11a7483f1d84.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 |
|---|
| 76420-494-01 | 76420049401 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-494-01) | 2022-10-05 | 0000-00-00 | No | No | Current |
| 76420-494-30 | 76420049430 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-494-30) | 2022-10-05 | 0000-00-00 | No | No | Current |
| 76420-494-60 | 76420049460 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-494-60) | 2022-10-05 | 0000-00-00 | No | No | Current |
| 76420-494-90 | 76420049490 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-494-90) | 2022-10-05 | 0000-00-00 | No | No | Current |