Zolpidem
- Product NDC
- 63629-9613
- 11-digit product format
- 636299613
- Labeler code
- 63629
- Product ID
- 63629-9613_e5e05dd8-d19e-4562-9ea1-f02b02ea6407
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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 Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [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 | 854876 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-9613-1 | Zolpidem | 1000 in 1 BOTTLE | TABLET | 1000 | | 103 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-9613 | ZOLPIDEM (ZOLPIDEM TARTRATE) TABLET [BRYANT RANCH PREPACK] | 103 | Current NDC, 1 package rows | 20240511_70d7cfc3-7e54-4cd8-8911-7cf115d5c820.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 63629-9613-1 | 63629961301 | 1000 TABLET in 1 BOTTLE (63629-9613-1) | 1000 tablet | 2023-02-03 | No | No | Current |