FDA.reportPublic FDA data

sunitinib 12.5 MG Oral Capsule [Sutent]

RxCUI
616283
RxNorm name
sunitinib 12.5 MG Oral Capsule [Sutent]
Display name
sunitinib 12.5 MG Oral Capsule [Sutent]
Full name
sunitinib 12.5 MG Oral Capsule [Sutent]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:56

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUTENTSUNITINIB MALATEPfizer Laboratories Div Pfizer Inc43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c2026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616283

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
43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9cSutent 12.5 MG Oral Capsule [PSN] · sunitinib 12.5 MG Oral Capsule [Sutent] [SBD] · Sutent 12.5 MG (as sunitinib malate 16.7 MG) Oral Capsule [SY] · Sutent 12.5 MG Oral Capsule [SY]450These highlights do not include all the information needed to use SUTENT safely and effectively. See full prescribing information for SUTENT. SUTENT ® (sunitinib malate) capsules, for oral use Initial U.S. Approval: 200620260220