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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9csunitinib 12.5 MG Oral Capsule [Sutent]SBD50These 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
43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9cSutent 12.5 MG Oral CapsulePSN50These 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
43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9cSutent 12.5 MG Oral CapsuleSY50These 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
43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9cSutent 12.5 MG (as sunitinib malate 16.7 MG) Oral CapsuleSY50These 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