Home NDC 63539-017-01 SUTENT
Product NDC 63539-017
Requested package NDC 63539-017-01
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021938-001 SUTENT SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB RLD 2006-01-26 N021938-002 SUTENT SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB RLD 2006-01-26 N021938-003 SUTENT SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB RLD, RS 2006-01-26 N021938-004 SUTENT SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB RLD 2009-03-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N021938-001 SUTENT EQ 12.5MG BASE CAPSULE / ORAL AB RLD 2006-01-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N021938-002 SUTENT EQ 25MG BASE CAPSULE / ORAL AB RLD 2006-01-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N021938-003 SUTENT EQ 50MG BASE CAPSULE / ORAL AB RLD, RS 2006-01-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N021938-004 SUTENT EQ 37.5MG BASE CAPSULE / ORAL AB RLD 2009-03-31 a50c72e98297…
Observed Orange Book normalized TE history# 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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SUTENT SUNITINIB MALATE Pfizer Laboratories Div Pfizer Inc 43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c 2026-02-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021938 application number: NDA021938
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63539-017-01 SUTENT 28 in 1 BOTTLE CAPSULE 28 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63539-017 SUTENT (SUNITINIB MALATE) CAPSULE [U.S. PHARMACEUTICALS] 5 Current NDC, Legacy NDC, 1 package rows 20250325_a5d555f5-d66a-4f94-abcf-96fa6d71a32f.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63539-017-01 63539001701 28 CAPSULE in 1 BOTTLE (63539-017-01) 28 capsule 2018-06-05 0000-00-00 Yes No Current