Zolpidem
- Product NDC
- 71093-155
- 11-digit product format
- 710930155
- Labeler code
- 71093
- Product ID
- 71093-155_69a3d187-578f-4e49-b8b3-109219a7bdf6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ACI Healthcare USA, Inc
- Application
- ANDA077214
- Marketing category
- ANDA
- Marketing start
- 2020-09-24
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 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
- 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 | 854873, 854876 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71093-155-04 | Zolpidem | 100 in 1 BOTTLE | TABLET | 100 | | 7 |
| 71093-155-06 | Zolpidem | 1000 in 1 BOTTLE | TABLET | 1000 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71093-155 | ZOLPIDEM (ZOLPIDEM TARTRATE) TABLET [ACI HEALTHCARE USA, INC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20231217_021153ce-fe27-4ed1-8d88-b4157b0ed734.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 |
|---|
| 71093-155-04 | 71093015504 | 100 TABLET in 1 BOTTLE (71093-155-04) | 100 tablet | 2020-09-24 | 0000-00-00 | No | No | Current |
| 71093-155-06 | 71093015506 | 1000 TABLET in 1 BOTTLE (71093-155-06) | 1000 tablet | 2020-09-24 | 0000-00-00 | No | No | Current |