NDC 47335-308
Zolpidem Tartrate 12.5 mg tablet, film coated, extended release
On the label: Caraco Pharmaceutical Laboratories, Ltd..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | Dadra, India | Makes it and tests it | Problems found, fixed voluntarilyMar 29, 2019 · 5 inspections |
Recalls
- Jan 18, 2024 · Class II · Sun Pharmaceutical Industries Inc
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lots: Lot #: DNE0892A Exp. 07/31/2026 - Jan 18, 2024 · Class II · Sun Pharmaceutical Industries Inc
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lots: Lot #: DNE0893A Expires 07/31/2026
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Zolpidem: every company that makes it
- Form
- tablet, film coated, extended release, oral
- Strength
- 12.5 mg
- Approval
- ANDA ANDA204170
- On the market since
- May 15, 2017
- Package NDCs
47335-308-1347335-308-88- Official label
- DailyMed (National Library of Medicine), updated Oct 18, 2023
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