Active ingredient
Tacrolimus
106 finished FDA listings contain Tacrolimus as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- TACROLIMUS, TACROLIMUS ANHYDROUS
- Dosage forms
- Capsule, Capsule, Coated, Extended Release, Capsule, Extended Release, Capsule, Gelatin Coated, Granule, For Suspension, Injection, Injection, Solution, Ointment, Tablet, Extended Release
- Routes
- Intravenous, Oral, Topical
- Manufacturers / labelers
- 36
- Strengths listed
- .2 mg/1 · .3 mg/g · .5 mg/1 · .75 mg/1 · 1 mg/1 · 1 mg/g · 4 mg/1 · 5 mg/1 · 5 mg/ml
- Brand names in FDA listings
- Astagraf Xl, Envarsus Xr, Prograf, Tacrolimus
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 42316
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 050709 | ASTELLAS | 1994-04-08 | 1 |
| NDA 050708 | ASTELLAS | 1994-04-08 | 3 |
| NDA 050777 | LEO PHARMA AS | 2000-12-08 | 2 |
| ANDA 065461 | SANDOZ | 2009-08-10 | 10 |
| ANDA 090509 | DR REDDYS LABS LTD | 2010-05-12 | 13 |
| ANDA 090596 | MYLAN | 2010-09-17 | 13 |
| ANDA 091195 | ACCORD HLTHCARE | 2011-08-31 | 5 |
| ANDA 090802 | PANACEA | 2012-09-28 | 6 |
| NDA 204096 | ASTELLAS | 2013-07-19 | 3 |
| ANDA 090687 | STRIDES PHARMA | 2014-07-22 | 5 |
| ANDA 200744 | FOUGERA PHARMS INC | 2014-09-09 | 2 |
| NDA 206406 | VELOXIS PHARMS INC | 2015-07-10 | 3 |
| ANDA 206651 | AJENAT PHARMS | 2017-11-30 | 6 |
| ANDA 210393 | GLENMARK PHARMS LTD | 2018-04-16 | 2 |
| NDA 210115 | ASTELLAS | 2018-05-24 | 2 |
| ANDA 211688 | ACCORD HLTHCARE | 2019-01-31 | 2 |
| ANDA 206662 | GLENMARK PHARMS LTD | 2020-11-10 | 7 |
| ANDA 212297 | BIOCON PHARMA | 2020-11-10 | 4 |
| ANDA 213112 | CONCORD BIOTECH LTD | 2020-11-10 | 6 |
| ANDA 203740 | ALKEM LABS LTD | 2020-11-12 | 3 |
| ANDA 212387 | ENCUBE | 2023-10-10 | 1 |
| ANDA 215012 | CHENGDU | 2024-01-25 | 6 |
| ANDA 217108 | NEXUS | 2025-02-12 | 1 |
Official labeling on DailyMed
- TACROLIMUS CAPSULE [MAJOR PHARMACEUTICALS] · version 5 · 2026-07-28
- TACROLIMUS CAPSULE [STELLON BIOTECH INC.] · version 3 · 2026-07-20
- TACROLIMUS CAPSULE [A-S MEDICATION SOLUTIONS] · version 5 · 2026-06-23
- TACROLIMUS CAPSULE [NORTHSTAR RX LLC] · version 4 · 2026-06-08
- TACROLIMUS CAPSULE [MAJOR PHARMACEUTICALS] · version 7 · 2026-06-08
- TACROLIMUS (TACROLIMUS) CAPSULE [BIOCON PHARMA INC.] · version 12 · 2026-05-26
- TACROLIMUS CAPSULE [STRIDES PHARMA SCIENCE LIMITED] · version 19 · 2026-05-25
- TACROLIMUS OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] · version 8 · 2026-04-16
- TACROLIMUS CAPSULE [SAFECOR HEALTH LLC] · version 3 · 2026-04-09
- TACROLIMUS CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS NY LLC] · version 1 · 2026-03-25
- TACROLIMUS CAPSULE, GELATIN COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] · version 2 · 2026-03-23
- TACROLIMUS OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS, LLC] · version 13 · 2026-02-27
Showing the 12 most recent of 45 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.