NDC 68180-481

Simvastatin 80 mg tablet, film coated

On the label: Lupin Pharmaceuticals, Inc..

Where it's made

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.

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.

Product details

Generic drug

Simvastatin: see every company that makes it

Form

tablet, film coated

Strength

80 mg

Approval

ANDA ANDA078103

On the market since

Nov 23, 2015

Package NDCs

68180-481-01 68180-481-02 68180-481-03

Official label

DailyMed (National Library of Medicine), updated Jan 13, 2026

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