ZOLPIDEM TARTRATE
- Product NDC
- 63187-565
- 11-digit product format
- 631870565
- Labeler code
- 63187
- Product ID
- 63187-565_ae552b3d-c4e7-4abb-9132-0ffc2b477567
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zolpidem tartrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA077903
- Marketing category
- ANDA
- Marketing start
- 2007-09-05
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WY6W63843K |
| Rxcui | 854873 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-565-15 | ZOLPIDEM TARTRATE | 15 in 1 BOTTLE | TABLET | 15 | | 5 |
| 63187-565-30 | ZOLPIDEM TARTRATE | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 63187-565-60 | ZOLPIDEM TARTRATE | 60 in 1 BOTTLE | TABLET | 60 | | 5 |
| 63187-565-90 | ZOLPIDEM TARTRATE | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-565 | ZOLPIDEM TARTRATE TABLET [PROFICIENT RX LP] | 5 | Current NDC, Legacy NDC, 4 package rows | 20220722_eaca34da-2b12-4dd4-91b5-a8446c7bd41e.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 |
|---|
| 63187-565-15 | 63187056515 | 15 TABLET in 1 BOTTLE (63187-565-15) | 15 tablet | 2018-12-01 | 0000-00-00 | No | No | Current |
| 63187-565-30 | 63187056530 | 30 TABLET in 1 BOTTLE (63187-565-30) | 30 tablet | 2018-12-01 | 0000-00-00 | No | No | Current |
| 63187-565-60 | 63187056560 | 60 TABLET in 1 BOTTLE (63187-565-60) | 60 tablet | 2018-12-01 | 0000-00-00 | No | No | Current |
| 63187-565-90 | 63187056590 | 90 TABLET in 1 BOTTLE (63187-565-90) | 90 tablet | 2018-12-01 | 0000-00-00 | No | No | Current |