FDA.reportPublic FDA data

SUTENT

Product NDC
63539-017
11-digit product format
635390017
Labeler code
63539
Product ID
63539-017_21cadbc0-3f0e-4789-80ee-bf1e3982d85f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sunitinib malate
Dosage form
CAPSULE
Route
ORAL
Labeler
U.S. Pharmaceuticals
Application
NDA021938
Marketing category
NDA
Marketing start
2006-01-26
Substance
SUNITINIB MALATE
Active strength
12.5 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63539-017DDiscontinued by firm2026-07-31
excluded packagepackage63539-01763539-017-01DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021938-001SUTENTSUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALABRLD2006-01-26
N021938-002SUTENTSUNITINIB MALATEEQ 25MG BASECAPSULE / ORALABRLD2006-01-26
N021938-003SUTENTSUNITINIB MALATEEQ 50MG BASECAPSULE / ORALABRLD, RS2006-01-26
N021938-004SUTENTSUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALABRLD2009-03-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N021938-001AB
N021938-002AB
N021938-003AB
N021938-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021938-001SUTENTEQ 12.5MG BASECAPSULE / ORALABRLD2006-01-26a50c72e98297…
2026-08-01 22:54:322026-06N021938-002SUTENTEQ 25MG BASECAPSULE / ORALABRLD2006-01-26a50c72e98297…
2026-08-01 22:54:322026-06N021938-003SUTENTEQ 50MG BASECAPSULE / ORALABRLD, RS2006-01-26a50c72e98297…
2026-08-01 22:54:322026-06N021938-004SUTENTEQ 37.5MG BASECAPSULE / ORALABRLD2009-03-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021938-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N021938-002AB1a50c72e98297…
2026-08-01 22:54:322026-06N021938-003AB1a50c72e98297…
2026-08-01 22:54:322026-06N021938-004AB1a50c72e98297…

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
application applno (NDA): 021938
application number: NDA021938

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c71c27c5-81ab-f132-824f-21f56518b6f9Product name320250516

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63539-017-012021-08-14C16284748780-1c7ccaba7-18e4-fd44-e053-dadaa90aa01bThese 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: 2006
63539-017-012021-07-23C16284748780-1c7ccaba7-18e4-fd44-e053-dadaa90aa01bThese 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: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63539-017-01SUTENT28 in 1 BOTTLECAPSULE286

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63539-017SUTENT (SUNITINIB MALATE) CAPSULE [U.S. PHARMACEUTICALS]5Current NDC, Legacy NDC, 1 package rows20250325_a5d555f5-d66a-4f94-abcf-96fa6d71a32f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63539-017-016353900170128 CAPSULE in 1 BOTTLE (63539-017-01) 28 capsule2018-06-050000-00-00YesNoCurrent