Zolpidem Tartrate
- Product NDC
- 42291-963
- 11-digit product format
- 422910963
- Labeler code
- 42291
- Product ID
- 42291-963_d5ca211e-def6-d9aa-e053-2995a90a3570
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA076410
- Marketing category
- ANDA
- Marketing start
- 2019-02-21
- Marketing end
- 0000-00-00
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 5 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 Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-963 | ZOLPIDEM TARTRATE TABLET, FILM COATED [AVKARE] | 5 | Legacy NDC | 20240111_8247ff5c-c3da-f800-e053-2991aa0a9c48.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42291-963-01 | 42291096301 | 100 TABLET, FILM COATED in 1 BOTTLE (42291-963-01) | 2019-02-21 | 0000-00-00 | No | No | Current |
| 42291-963-10 | 42291096310 | 1000 TABLET, FILM COATED in 1 BOTTLE (42291-963-10) | 2019-02-21 | 0000-00-00 | No | No | Current |
| 42291-963-30 | 42291096330 | 30 TABLET, FILM COATED in 1 BOTTLE (42291-963-30) | 2020-04-29 | 0000-00-00 | No | No | Current |