FDA Orange Book

Generic for Vytorin

Vytorin contains ezetimibe and simvastatin. 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 Vytorin is ezetimibe and simvastatin. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Vytorin products in the Orange Book

Vytorin products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	10MG;10MG	Marketed (Rx)	AB	4	AB
tablet, oral	10MG;20MG	Marketed (Rx)	AB	4	AB
tablet, oral	10MG;40MG	Marketed (Rx)	AB	4	AB
tablet, oral	10MG;80MG	Marketed (Rx)	AB	4	AB

NDA 021687, held by ORGANON LLC A SUB OF ORGANON AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic ezetimibe and simvastatin

Approved generic versions of Vytorin
Company	ANDA	TE code	Approved	Strengths
DR REDDYS LABORATORIES SA	200909	AB (A-rated, therapeutically equivalent)	April 26, 2017	10MG;10MG, 10MG;20MG, 10MG;40MG, 10MG;80MG
ALKEM LABORATORIES LTD	209222	AB (A-rated, therapeutically equivalent)	December 22, 2017	10MG;10MG, 10MG;20MG, 10MG;40MG, 10MG;80MG
GLENMARK PHARMACEUTICALS LTD	208699	AB (A-rated, therapeutically equivalent)	June 27, 2019	10MG;10MG, 10MG;20MG, 10MG;40MG, 10MG;80MG
AUROBINDO PHARMA USA INC	200082	AB (A-rated, therapeutically equivalent)	December 17, 2020	10MG;10MG, 10MG;20MG, 10MG;40MG, 10MG;80MG

Vytorin NDC codes

Questions

Is there a generic for Vytorin?

Yes. The generic name for Vytorin is ezetimibe and simvastatin. 4 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 Vytorin?

The active ingredient in Vytorin is ezetimibe and simvastatin, 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.