FDA Orange Book

Generic for Lescol

Lescol contains fluvastatin. 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 Lescol is fluvastatin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Lescol products in the Orange Book

Lescol products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
capsule, oral	EQ 20MG BASE	Discontinued	None	2	AB
capsule, oral	EQ 40MG BASE	Discontinued	None	2	AB

NDA 020261, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic fluvastatin

Approved generic versions of Lescol
Company	ANDA	TE code	Approved	Strengths
MYLAN PHARMACEUTICALS INC.	090595	AB (A-rated, therapeutically equivalent)	April 11, 2012	EQ 20MG BASE, EQ 40MG BASE
TEVA PHARMACEUTICALS USA	078407	AB (A-rated, therapeutically equivalent)	June 12, 2012	EQ 20MG BASE, EQ 40MG BASE

Questions

Is there a generic for Lescol?

Yes. The generic name for Lescol is fluvastatin. 2 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 Lescol?

The active ingredient in Lescol is fluvastatin, 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.