FDA.reportPublic FDA data

tacrolimus 0.5 MG 24HR Extended Release Oral Capsule

RxCUI
1431971
RxNorm name
tacrolimus 0.5 MG 24HR Extended Release Oral Capsule
Display name
tacrolimus 0.5 MG 24HR Extended Release Oral Capsule
Full name
tacrolimus 0.5 MG 24HR Extended Release Oral Capsule
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:59

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ASTAGRAF XLTACROLIMUS EXTENDED-RELEASE CAPSULESAstellas Pharma US, Inc.550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1431971
TacrolimusTACROLIMUSAmneal Pharmaceuticals NY LLC4eb1b6bd-beec-4dd5-9a48-c93a9fe918b32025-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1431971
tacrolimusTACROLIMUS EXTENDED-RELEASE CAPSULESChengdu Suncadia Medicine Co., Ltd.08cf2861-2483-405d-a872-a88a5c235f9a2024-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1431971

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
550a5cd4-fbf2-4c09-b577-6bde8fcbdf6etacrolimus 0.5 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR tacrolimus 0.5 MG Extended Release Oral Capsule [SCD] · tacrolimus 0.5 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral Capsule [SY]312These highlights do not include all the information needed to use ASTAGRAF XL ® safely and effectively. See full prescribing information for ASTAGRAF XL. ASTAGRAF XL (tacrolimus extended-release capsules), for oral use Initial U.S. Approval: 199420260114
08cf2861-2483-405d-a872-a88a5c235f9atacrolimus 0.5 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR tacrolimus 0.5 MG Extended Release Oral Capsule [SCD] · tacrolimus 0.5 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral Capsule [SY]35These highlights do not include all the information needed to use TACROLIMUS EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for TACROLIMUS EXTENDED-RELEASE CAPSULES. TACROLIMUS extended-release capsules, for oral use Initial U.S. Approval: 199420240207
4eb1b6bd-beec-4dd5-9a48-c93a9fe918b3tacrolimus 0.5 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR tacrolimus 0.5 MG Extended Release Oral Capsule [SCD] · tacrolimus 0.5 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral Capsule [SY]31These highlights do not include all the information needed to use TACROLIMUS EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for TACROLIMUS EXTENDED-RELEASE CAPSULES. TACROLIMUS extended-release capsules, for oral use Initial U.S. Approval: 199420251020