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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.

ApplicationSponsorOriginal approvalListings
NDA 050709ASTELLAS1994-04-081
NDA 050708ASTELLAS1994-04-083
NDA 050777LEO PHARMA AS2000-12-082
ANDA 065461SANDOZ2009-08-1010
ANDA 090509DR REDDYS LABS LTD2010-05-1213
ANDA 090596MYLAN2010-09-1713
ANDA 091195ACCORD HLTHCARE2011-08-315
ANDA 090802PANACEA2012-09-286
NDA 204096ASTELLAS2013-07-193
ANDA 090687STRIDES PHARMA2014-07-225
ANDA 200744FOUGERA PHARMS INC2014-09-092
NDA 206406VELOXIS PHARMS INC2015-07-103
ANDA 206651AJENAT PHARMS2017-11-306
ANDA 210393GLENMARK PHARMS LTD2018-04-162
NDA 210115ASTELLAS2018-05-242
ANDA 211688ACCORD HLTHCARE2019-01-312
ANDA 206662GLENMARK PHARMS LTD2020-11-107
ANDA 212297BIOCON PHARMA2020-11-104
ANDA 213112CONCORD BIOTECH LTD2020-11-106
ANDA 203740ALKEM LABS LTD2020-11-123
ANDA 212387ENCUBE2023-10-101
ANDA 215012CHENGDU2024-01-256
ANDA 217108NEXUS2025-02-121

Official labeling on DailyMed

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.