FDA Orange Book

Generic for Pentasa

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

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Pentasa products in the Orange Book

Pentasa products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
capsule, extended release, oral	250MG	Marketed (Rx)	AB	1	AB
capsule, extended release, oral	500MG	Marketed (Rx)	AB	2	AB

NDA 020049, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic mesalamine

Approved generic versions of Pentasa
Company	ANDA	TE code	Approved	Strengths
SUN PHARMACEUTICAL INDUSTRIES LTD	214585	AB (A-rated, therapeutically equivalent)	May 11, 2022	500MG
SANDOZ INC	219997	AB (A-rated, therapeutically equivalent)	March 10, 2026	250MG, 500MG

Pentasa NDC codes

Questions

Is there a generic for Pentasa?

Yes. The generic name for Pentasa is mesalamine. 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 Pentasa?

The active ingredient in Pentasa is mesalamine, 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.