NDC 68071-4167
Finasteride 1 mg tablet, film coated
On the label: NuCare Pharmaceuticals.Inc.. It's repackaged: NuCare Pharmaceuticals.Inc. rebottles it from Accord Healthcare Inc.'s NDC 16729-089.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | No problems foundJul 12, 2024 · 10 inspections |
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | Serious problems, FDA actionDec 2, 2022 · 7 inspections, 1 with FDA action |
Repackaging site
- NuCare Pharmaceuticals,Inc., Orange, CA, United States · relabels it
Recalls
- Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a) P2005979, Exp. Date 10/31/2023; P2100252, Exp. Date 12/31/2023; P2101710, Exp. Date 2/29/2024; b) P2100253, Exp. Date 12/31/2023; P2103035, Exp. Date 4/30/2024; P2103036, Exp. Date 4/30/2024;
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Finasteride: every company that makes it
- Form
- tablet, film coated
- Strength
- 1 mg
- Approval
- ANDA ANDA091643
- On the market since
- Nov 8, 2013
- Package NDCs
68071-4167-3- Official label
- DailyMed (National Library of Medicine), updated May 28, 2021
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