ZOLPIDEM TARTRATE
- Product NDC
- 43386-762
- 11-digit product format
- 433860762
- Labeler code
- 43386
- Product ID
- 43386-762_b4684db4-fae2-5bc4-e053-2995a90a9cd1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zolpidem tartrate
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA204299
- Marketing category
- ANDA
- Marketing start
- 2016-03-22
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 1.75 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 | 1.75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WY6W63843K |
| Rxcui | 1232194, 1232202 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43386-762-01 | ZOLPIDEM TARTRATE | 1 in 1 BLISTER PACK | TABLET | 1 | | 6 |
| 43386-762-01 | ZOLPIDEM TARTRATE | 1 in 1 POUCH | TABLET | 1 | | 6 |
| 43386-762-30 | ZOLPIDEM TARTRATE | 30 in 1 CARTON | TABLET | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-762 | ZOLPIDEM TARTRATE TABLET [LUPIN PHARMACEUTICALS,INC.] | 6 | Current NDC, Legacy NDC, 3 package rows | 20201119_6db679f6-b1f8-4fbf-9e87-9cef4650c45a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43386-762-01 | 43386076201 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 43386-762-30 | 43386076230 | 30 POUCH in 1 CARTON (43386-762-30) / 1 BLISTER PACK in 1 POUCH (43386-762-01) / 1 TABLET in 1 BLISTER PACK | 30 pouch | 2016-03-22 | 0000-00-00 | No | No | Current |