FDA.reportPublic FDA data

Envarsus XR 1 MG 24HR Extended Release Oral Tablet

RxCUI
1664463
RxNorm name
Envarsus XR 1 MG 24HR Extended Release Oral Tablet
Display name
Envarsus XR 1 MG 24HR Extended Release Oral Tablet
Full name
Envarsus XR 1 MG 24HR Extended Release Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:24

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Envarsus XRTACROLIMUSVeloxis Pharmaceuticals, Incde2315b0-6344-43ac-9aea-3e3b68d828e72025-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1664463

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

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

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
de2315b0-6344-43ac-9aea-3e3b68d828e7Envarsus XR 1 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR tacrolimus 1 MG Extended Release Oral Tablet [Envarsus] [SBD] · 24 HR Envarsus 1 MG Extended Release Oral Tablet [SY] · Envarsus XR 1 MG 24HR Extended Release Oral Tablet [SY]416These highlights do not include all the information needed to use ENVARSUS XR ® safely and effectively. See full prescribing information for ENVARSUS XR. ENVARSUS XR ® (tacrolimus extended-release tablets), for oral use Initial U.S. Approval: 199420250226