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.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Astellas Pharma US, Inc. | 6 | capsule, gelatin coated; granule, for suspension | New drug applications (NDA) | May 24, 2018 |
| Accord Healthcare Inc. | 5 | capsule; ointment | Generic drugs (ANDA) | May 31, 2019 |
| Bryant Ranch Prepack | 5 | capsule | Generic drugs (ANDA) | September 30, 2011 |
| Glenmark Pharmaceuticals Inc., USA | 5 | capsule; ointment | Generic drugs (ANDA) | August 16, 2023 |
| Ajenat Pharmaceuticals LLC | 3 | capsule | Generic drugs (ANDA) | January 31, 2023 |
| American Health Packaging | 3 | capsule | Generic drugs (ANDA) | August 3, 2010 |
| Amneal Pharmaceuticals NY LLC | 3 | capsule, extended release | Generic drugs (ANDA) | March 2, 2026 |
| Ascend Laboratories, LLC | 3 | capsule | Generic drugs (ANDA) | November 13, 2020 |
| Biocon Pharma Inc. | 3 | capsule | Generic drugs (ANDA) | December 23, 2020 |
| Bpi Labs LLC | 3 | capsule | Generic drugs (ANDA) | April 8, 2020 |
| Concord Biotech Limited | 3 | capsule | Generic drugs (ANDA) | November 23, 2020 |
| Dr. Reddy's Laboratories Limited | 3 | capsule | Generic drugs (ANDA) | May 14, 2010 |
| Golden State Medical Supply, Inc. | 3 | capsule | Generic drugs (ANDA) | September 17, 2010 |
| Jubilant Cadista Pharmaceuticals Inc. | 3 | capsule, gelatin coated | Generic drugs (ANDA) | November 30, 2024 |
| Major Pharmaceuticals | 3 | capsule | Generic drugs (ANDA) | August 13, 2014 |
| Mylan Institutional Inc. | 3 | capsule | Generic drugs (ANDA) | November 15, 2010 |
| Mylan Pharmaceuticals Inc. | 3 | capsule | Generic drugs (ANDA) | September 17, 2010 |
| NorthStar Rx LLC | 3 | capsule | Generic drugs (ANDA) | March 31, 2021 |
| Panacea Biotec Limited | 3 | capsule, gelatin coated | Generic drugs (ANDA) | February 26, 2016 |
| Quallent Pharmaceuticals Health LLC | 3 | capsule | Generic drugs (ANDA) | June 1, 2025 |
| Safecor Health, LLC | 3 | capsule | Generic drugs (ANDA) | March 13, 2026 |
| Sandoz Inc | 3 | capsule | Generic drugs (ANDA) | August 10, 2009 |
| Stellon Biotech Inc. | 3 | capsule | Generic drugs (ANDA) | August 7, 2025 |
| Strides Pharma Science Limited | 3 | capsule | Generic drugs (ANDA) | October 5, 2020 |
| Veloxis Pharmaceuticals, Inc | 3 | tablet, extended release | New drug applications (NDA) | September 1, 2015 |
| A-S Medication Solutions | 2 | capsule | Generic drugs (ANDA) | November 10, 2020 |
| AvPAK | 2 | capsule | Generic drugs (ANDA) | September 20, 2026 |
| Cardinal Health 107, LLC | 2 | capsule | Generic drugs (ANDA) | December 23, 2020 |
| E. Fougera & Co. a Division of Fougera Pharmaceuticals, LLC | 2 | ointment | Generic drugs (ANDA) | September 9, 2014 |
| Padagis Israel Pharmaceuticals Ltd | 2 | ointment | New drug applications (NDA) | November 20, 2014 |
| Aphena Pharma Solutions - Tennessee, LLC | 1 | capsule | Generic drugs (ANDA) | November 18, 2015 |
| Bryant Ranch Prepack | 1 | capsule | Generic drugs (ANDA) | September 30, 2011 |
| Direct_Rx | 1 | capsule | Generic drugs (ANDA) | February 7, 2024 |
| Nexus Pharmaceuticals LLC | 1 | injection | Generic drugs (ANDA) | December 1, 2025 |
| Proficient Rx LP | 1 | capsule | Generic drugs (ANDA) | August 10, 2009 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Capsule | 72 | 72.7% |
| Capsule, gelatin coated | 9 | 9.1% |
| Ointment | 8 | 8.1% |
| Capsule, extended release | 3 | 3% |
| Tablet, extended release | 3 | 3% |
| Granule, for suspension | 2 | 2% |
| Injection | 1 | 1% |
| Injection, solution | 1 | 1% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 88 | 88.9% |
| New drug applications (NDA) | 11 | 11.1% |
Pharmacologic classes
| Class | Products |
|---|---|
| Calcineurin Inhibitor Immunosuppressant | 99 |
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.