Zolpidem Tartrate
- Product NDC
- 68788-8118
- 11-digit product format
- 687888118
- Labeler code
- 68788
- Product ID
- 68788-8118_be2188b1-36f4-4ffe-b291-e732d21ac4cf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA213592
- Marketing category
- ANDA
- Marketing start
- 2021-12-10
- Marketing end
- 0000-00-00
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 6 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8118 | ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.] | 4 | Legacy NDC | 20240906_a34198bc-69f9-4dbe-afec-7e99bfe379d1.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-8118-3 | 68788811803 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8118-3) | 2021-12-10 | 0000-00-00 | No | No | Current |
| 68788-8118-6 | 68788811806 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8118-6) | 2021-12-10 | 0000-00-00 | No | No | Current |
| 68788-8118-9 | 68788811809 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8118-9) | 2021-12-10 | 0000-00-00 | No | No | Current |