Home NDC 0069-0980 SUTENT
Product NDC 0069-0980
11-digit product format 000690980
Labeler code 0069
Product ID 0069-0980_530eef58-b5ab-49f1-8d73-a2dae0356f24
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sunitinib malate
Dosage form CAPSULE
Route ORAL
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA021938
Marketing category NDA
Marketing start 2006-01-26
Substance SUNITINIB MALATE
Active strength 50 mg/1
Pharmacologic classes Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 ndc (product): 0069-0980
Additional Listing Data#
Finished product Yes
Brand name base SUTENT
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SUNITINIB MALATE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LVX8N1UT73 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 616279 Internal RxNorm lookup 616283 Internal RxNorm lookup 616285 Internal RxNorm lookup 616287 Internal RxNorm lookup 616289 Internal RxNorm lookup 616292 Internal RxNorm lookup 1541890 Internal RxNorm lookup 1541928 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0069-0980-38 SUTENT 28 in 1 BOTTLE CAPSULE 28 50
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0069-0980 SUTENT (SUNITINIB MALATE) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC] 48 Current NDC, Legacy NDC, 1 package rows 20250402_43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0069-0980-38 00069098038 28 CAPSULE in 1 BOTTLE (0069-0980-38) 28 capsule 2006-01-26 0000-00-00 No No Current