Lupin Limited
Salcette, India · makes it and packages it
Problems found, fixed voluntarily Last FDA inspection Nov 21, 2025. 9 inspections on record, 1 with serious problems.
NDC 68084-511
Simvastatin 10 mg tablet, film coated
On the label: American Health Packaging.
It's a repackaged product: American Health Packaging rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-478.
Where the pills inside were made
Lupin Limited
Pithampur, India · makes it and packages it
Serious problems, FDA action Last FDA inspection Jul 17, 2025. 6 inspections on record, 4 with serious problems.
Repackaging site
- American Health Packaging, Columbus, OH, United States · repackages it
Product details
- Generic drug
- Simvastatin: see every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 10 mg
- Approval
- ANDA ANDA078103
- On the market since
- Aug 19, 2011
- Package NDCs
68084-511-0168084-511-11- Official label
- DailyMed (National Library of Medicine), updated Aug 25, 2025
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