NDC 76420-496
Zolpidem Tartrate 12.5 mg tablet, extended release
On the label: Asclemed USA, Inc.. It's repackaged: Asclemed USA, Inc. rebottles it from Breckenridge Pharmaceutical, Inc.'s NDC 51991-982.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Centaur Pharmaceuticals Private Limited | Pune, India | Makes it | Serious problems, FDA actionFeb 8, 2023 · 5 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 ANDA213592
- On the market since
- Dec 17, 2020
- Package NDCs
76420-496-0176420-496-3076420-496-6076420-496-90- Official label
- DailyMed (National Library of Medicine), updated Oct 5, 2022
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