FDA Orange Book

Generic for Astagraf XL

Astagraf XL contains tacrolimus. 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 Astagraf XL is tacrolimus. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Astagraf XL products in the Orange Book

Astagraf XL products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
capsule, extended release, oral	EQ 0.5MG BASE	Marketed (Rx)	AB	1	AB
capsule, extended release, oral	EQ 1MG BASE	Marketed (Rx)	AB	1	AB
capsule, extended release, oral	EQ 5MG BASE	Marketed (Rx)	AB	1	AB

NDA 204096, held by ASTELLAS PHARMA US INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic tacrolimus

Approved generic versions of Astagraf XL
Company	ANDA	TE code	Approved	Strengths
CHENGDU SUNCADIA MEDICINE CO LTD	215012	AB (A-rated, therapeutically equivalent)	January 25, 2024	EQ 0.5MG BASE, EQ 1MG BASE, EQ 5MG BASE

Astagraf XL NDC codes

Questions

Is there a generic for Astagraf XL?

Yes. The generic name for Astagraf XL is tacrolimus. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Astagraf XL?

The active ingredient in Astagraf XL is tacrolimus, 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.