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Data / Drug companies / Tacrolimus

Tacrolimus: 35 companies and 99 products in the FDA NDC directory

Tacrolimus is listed in the FDA National Drug Code Directory by 35 companies, with 99 products in commercial distribution. 88 of the products (88.9%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are capsule; capsule, gelatin coated; ointment, and the newest product started marketing on September 20, 2026.

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Companies listing it
35
Products
99
Generic (ANDA) products
88 (88.9%)
Application numbers
21
Routes
Oral, Topical, Intravenous
Brand names
Prograf, Envarsus XR
openFDA record search
api.fda.gov

Companies that list tacrolimus

Ranked by number of products. Finished drugs in commercial distribution.

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Astellas Pharma US, Inc.6capsule, gelatin coated; granule, for suspensionNew drug applications (NDA)May 24, 2018
Accord Healthcare Inc.5capsule; ointmentGeneric drugs (ANDA)May 31, 2019
Bryant Ranch Prepack5capsuleGeneric drugs (ANDA)September 30, 2011
Glenmark Pharmaceuticals Inc., USA5capsule; ointmentGeneric drugs (ANDA)August 16, 2023
Ajenat Pharmaceuticals LLC3capsuleGeneric drugs (ANDA)January 31, 2023
American Health Packaging3capsuleGeneric drugs (ANDA)August 3, 2010
Amneal Pharmaceuticals NY LLC3capsule, extended releaseGeneric drugs (ANDA)March 2, 2026
Ascend Laboratories, LLC3capsuleGeneric drugs (ANDA)November 13, 2020
Biocon Pharma Inc.3capsuleGeneric drugs (ANDA)December 23, 2020
Bpi Labs LLC3capsuleGeneric drugs (ANDA)April 8, 2020
Concord Biotech Limited3capsuleGeneric drugs (ANDA)November 23, 2020
Dr. Reddy's Laboratories Limited3capsuleGeneric drugs (ANDA)May 14, 2010
Golden State Medical Supply, Inc.3capsuleGeneric drugs (ANDA)September 17, 2010
Jubilant Cadista Pharmaceuticals Inc.3capsule, gelatin coatedGeneric drugs (ANDA)November 30, 2024
Major Pharmaceuticals3capsuleGeneric drugs (ANDA)August 13, 2014
Mylan Institutional Inc.3capsuleGeneric drugs (ANDA)November 15, 2010
Mylan Pharmaceuticals Inc.3capsuleGeneric drugs (ANDA)September 17, 2010
NorthStar Rx LLC3capsuleGeneric drugs (ANDA)March 31, 2021
Panacea Biotec Limited3capsule, gelatin coatedGeneric drugs (ANDA)February 26, 2016
Quallent Pharmaceuticals Health LLC3capsuleGeneric drugs (ANDA)June 1, 2025
Safecor Health, LLC3capsuleGeneric drugs (ANDA)March 13, 2026
Sandoz Inc3capsuleGeneric drugs (ANDA)August 10, 2009
Stellon Biotech Inc.3capsuleGeneric drugs (ANDA)August 7, 2025
Strides Pharma Science Limited3capsuleGeneric drugs (ANDA)October 5, 2020
Veloxis Pharmaceuticals, Inc3tablet, extended releaseNew drug applications (NDA)September 1, 2015
A-S Medication Solutions2capsuleGeneric drugs (ANDA)November 10, 2020
AvPAK2capsuleGeneric drugs (ANDA)September 20, 2026
Cardinal Health 107, LLC2capsuleGeneric drugs (ANDA)December 23, 2020
E. Fougera & Co. a Division of Fougera Pharmaceuticals, LLC2ointmentGeneric drugs (ANDA)September 9, 2014
Padagis Israel Pharmaceuticals Ltd2ointmentNew drug applications (NDA)November 20, 2014
Aphena Pharma Solutions - Tennessee, LLC1capsuleGeneric drugs (ANDA)November 18, 2015
Bryant Ranch Prepack1capsuleGeneric drugs (ANDA)September 30, 2011
Direct_Rx1capsuleGeneric drugs (ANDA)February 7, 2024
Nexus Pharmaceuticals LLC1injectionGeneric drugs (ANDA)December 1, 2025
Proficient Rx LP1capsuleGeneric drugs (ANDA)August 10, 2009

Dosage forms

Dosage formProductsShare
Capsule7272.7%
Capsule, gelatin coated99.1%
Ointment88.1%
Capsule, extended release33%
Tablet, extended release33%
Granule, for suspension22%
Injection11%
Injection, solution11%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)8888.9%
New drug applications (NDA)1111.1%

Pharmacologic classes

Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.