FDA.reportPublic FDA data

tacrolimus 5 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral Capsule

RxCUI
1431985
RxNorm name
tacrolimus 5 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral Capsule
Display name
tacrolimus 5 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral Capsule
Full name
tacrolimus 5 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral Capsule
Term type
SY
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: 1431985
TacrolimusTACROLIMUSAmneal Pharmaceuticals NY LLC4eb1b6bd-beec-4dd5-9a48-c93a9fe918b32025-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1431985
tacrolimusTACROLIMUS EXTENDED-RELEASE CAPSULESChengdu Suncadia Medicine Co., Ltd.08cf2861-2483-405d-a872-a88a5c235f9a2024-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1431985

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
550a5cd4-fbf2-4c09-b577-6bde8fcbdf6etacrolimus 5 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral CapsuleSY12These 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
550a5cd4-fbf2-4c09-b577-6bde8fcbdf6etacrolimus 5 MG 24HR Extended Release Oral CapsulePSN12These 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
550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e24 HR tacrolimus 5 MG Extended Release Oral CapsuleSCD12These 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-a88a5c235f9a24 HR tacrolimus 5 MG Extended Release Oral CapsuleSCD5These 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
08cf2861-2483-405d-a872-a88a5c235f9atacrolimus 5 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral CapsuleSY5These 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
08cf2861-2483-405d-a872-a88a5c235f9atacrolimus 5 MG 24HR Extended Release Oral CapsulePSN5These 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 5 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral CapsuleSY1These 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
4eb1b6bd-beec-4dd5-9a48-c93a9fe918b324 HR tacrolimus 5 MG Extended Release Oral CapsuleSCD1These 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
4eb1b6bd-beec-4dd5-9a48-c93a9fe918b3tacrolimus 5 MG 24HR Extended Release Oral CapsulePSN1These 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