Zolpidem Tartrate
- Product NDC
- 63187-682
- 11-digit product format
- 631870682
- Labeler code
- 63187
- Product ID
- 63187-682_1d5b9b11-cb94-486d-9780-aca61a75c076
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA076410
- Marketing category
- ANDA
- Marketing start
- 2007-04-23
- 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 |
|---|
| 63187-682-15 | Zolpidem Tartrate | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 3 |
| 63187-682-30 | Zolpidem Tartrate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 63187-682-60 | Zolpidem Tartrate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-682 | ZOLPIDEM TARTRATE TABLET, FILM COATED [PROFICIENT RX LP] | 3 | Current NDC, Legacy NDC, 3 package rows | 20191121_e534b3ac-1110-465f-8692-6ea585996fb6.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 |
|---|
| 63187-682-15 | 63187068215 | 15 TABLET, FILM COATED in 1 BOTTLE (63187-682-15) | 2016-04-01 | 0000-00-00 | No | No | Current |
| 63187-682-30 | 63187068230 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-682-30) | 2016-04-01 | 0000-00-00 | No | No | Current |
| 63187-682-60 | 63187068260 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-682-60) | 2016-04-01 | 0000-00-00 | No | No | Current |