FDA Orange Book
Generic for Mevacor
Mevacor contains lovastatin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Mevacor is lovastatin. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Mevacor products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Discontinued | None | 7 | AB |
| tablet, oral | 20MG | Discontinued | None | 7 | AB |
| tablet, oral | 40MG | Discontinued | None | 7 | AB |
NDA 019643, held by MERCK RESEARCH LABORATORIES DIV MERCK CO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic lovastatin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS ELIZABETH LLC | 075828 | AB (A-rated, therapeutically equivalent) | December 17, 2001 | 10MG, 20MG, 40MG |
| CHARTWELL RX SCIENCES LLC | 075300 | AB (A-rated, therapeutically equivalent) | December 17, 2001 | 10MG, 20MG, 40MG |
| EPIC PHARMA LLC | 075636 | AB (A-rated, therapeutically equivalent) | December 17, 2001 | 10MG, 20MG, 40MG |
| TEVA PHARMACEUTICALS USA INC | 075551 | AB (A-rated, therapeutically equivalent) | December 17, 2001 | 10MG, 20MG, 40MG |
| CARLSBAD TECHNOLOGY INC | 075991 | AB (A-rated, therapeutically equivalent) | June 5, 2002 | 10MG, 20MG, 40MG |
| MACLEODS PHARMACEUTICALS LTD | 077748 | AB (A-rated, therapeutically equivalent) | February 28, 2007 | 10MG, 20MG, 40MG |
| LUPIN LTD | 078296 | AB (A-rated, therapeutically equivalent) | March 14, 2008 | 10MG, 20MG, 40MG |
Questions
Is there a generic for Mevacor?
Yes. The generic name for Mevacor is lovastatin. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Mevacor?
The active ingredient in Mevacor is lovastatin, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.