NDC 76420-319
Zolpidem Tartrate 12.5 mg tablet, extended release
On the label: Asclemed USA, Inc.. It's repackaged: Asclemed USA, Inc. rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-780.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Salcette, India | Makes it and packages it | Problems found, fixed voluntarilyNov 21, 2025 · 9 inspections, 1 with FDA action |
Repackaging site
- Asclemed USA Inc. dba Enovachem, Torrance, CA, United States · repackages it and relabels it
Product details
- Generic drug
- Zolpidem: every company that makes it
- Form
- tablet, extended release, oral
- Strength
- 12.5 mg
- Approval
- ANDA ANDA078970
- On the market since
- Apr 11, 2014
- Package NDCs
76420-319-0176420-319-3076420-319-6076420-319-90- Official label
- DailyMed (National Library of Medicine), updated Apr 11, 2025
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