Zolpidem Tartrate
- Product NDC
- 10370-116
- 11-digit product format
- 103700116
- Labeler code
- 10370
- Product ID
- 10370-116_78c500a3-0492-4838-b8d2-c9a59aa43cdd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Par Pharmaceutical, Inc.
- Application
- ANDA078148
- Marketing category
- ANDA
- Marketing start
- 2011-12-06
- Marketing end
- 2023-07-31
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 13 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 10370-116-10 | 10370011610 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-116-10) | 2011-12-06 | 0000-00-00 | No | No | Current |