NDC 47335-613
Niacin 1000 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 #: DNE0788A Exp. 07/31/2025 - 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 #s: DNE0771A Exp. 06/30/2025; DNE0857A, DNE0959A Exp. 07/31/2025.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Niacin: every company that makes it
- Form
- tablet, film coated, extended release, oral
- Strength
- 1000 mg
- Approval
- ANDA ANDA200484
- On the market since
- Jun 27, 2014
- Package NDCs
47335-613-0847335-613-1847335-613-8147335-613-8347335-613-88- Official label
- DailyMed (National Library of Medicine), updated Nov 24, 2023
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