ZOLPIDEM TARTRATE
- Product NDC
- 82868-064
- 11-digit product format
- 828680064
- Labeler code
- 82868
- Product ID
- 82868-064_46dccd28-a51e-7582-e063-6294a90ad34a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zolpidem tartrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA077903
- Marketing category
- ANDA
- Marketing start
- 2024-08-01
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 10 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 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 |
|---|
| 82868-064-30 | ZOLPIDEM TARTRATE | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82868-064 | ZOLPIDEM TARTRATE TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 1 | Current NDC, 1 package rows | 20241116_26e20f53-c042-eac0-e063-6394a90acfca.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 |
|---|
| 82868-064-30 | 82868006430 | 30 TABLET in 1 BOTTLE, PLASTIC (82868-064-30) | 30 tablet | 2024-08-01 | No | No | Historical |