Drug

Who makes tacrolimus extended-release capsules?

2 companies list tacrolimus extended-release capsules as a human prescription drug, including under the names ASTAGRAF XL. Forms: capsule, coated, extended release. Routes: oral.

Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology

Companies listing tacrolimus extended-release capsules

CompanyFormsApplicationNDCsRegistered sites
Astellas Pharma US, Inc.Japancapsule, coated, extended releaseNDANDA20409638
Chengdu Suncadia Medicine Co., Ltd.Chinacapsule, coated, extended releaseANDAANDA21501231
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Common questions

Who makes tacrolimus extended-release capsules?
2 companies list tacrolimus extended-release capsules as a human prescription drug in the openFDA NDC Directory, led by Astellas Pharma US, Inc., Chengdu Suncadia Medicine Co., Ltd.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
Is there a generic ASTAGRAF XL?
1 company lists tacrolimus extended-release capsules under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.