Home NDC 63539-019 SUTENT
Product NDC 63539-019
11-digit product format 635390019
Labeler code 63539
Product ID 63539-019_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 50 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 42 .
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.
Product history page 1 of 5 · 168 observed 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 2026-08-18 06:07:40 2026-07 N021938-001 SUTENT EQ 12.5MG BASE CAPSULE / ORAL AB RLD 2006-01-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021938-002 SUTENT EQ 25MG BASE CAPSULE / ORAL AB RLD 2006-01-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021938-003 SUTENT EQ 50MG BASE CAPSULE / ORAL AB RLD, RS 2006-01-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021938-004 SUTENT EQ 37.5MG BASE CAPSULE / ORAL AB RLD 2009-03-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021938-001 SUTENT EQ 12.5MG BASE CAPSULE / ORAL AB RLD 2006-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021938-002 SUTENT EQ 25MG BASE CAPSULE / ORAL AB RLD 2006-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021938-003 SUTENT EQ 50MG BASE CAPSULE / ORAL AB RLD, RS 2006-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021938-004 SUTENT EQ 37.5MG BASE CAPSULE / ORAL AB RLD 2009-03-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021938-001 SUTENT EQ 12.5MG BASE CAPSULE / ORAL AB RLD 2006-01-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021938-002 SUTENT EQ 25MG BASE CAPSULE / ORAL AB RLD 2006-01-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021938-003 SUTENT EQ 50MG BASE CAPSULE / ORAL AB RLD, RS 2006-01-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021938-004 SUTENT EQ 37.5MG BASE CAPSULE / ORAL AB RLD 2009-03-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021938-001 SUTENT EQ 12.5MG BASE CAPSULE / ORAL AB RLD 2006-01-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021938-002 SUTENT EQ 25MG BASE CAPSULE / ORAL AB RLD 2006-01-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021938-003 SUTENT EQ 50MG BASE CAPSULE / ORAL AB RLD, RS 2006-01-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021938-004 SUTENT EQ 37.5MG BASE CAPSULE / ORAL AB RLD 2009-03-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021938-001 SUTENT EQ 12.5MG BASE CAPSULE / ORAL AB RLD 2006-01-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021938-002 SUTENT EQ 25MG BASE CAPSULE / ORAL AB RLD 2006-01-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021938-003 SUTENT EQ 50MG BASE CAPSULE / ORAL AB RLD, RS 2006-01-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021938-004 SUTENT EQ 37.5MG BASE CAPSULE / ORAL AB RLD 2009-03-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021938-001 SUTENT EQ 12.5MG BASE CAPSULE / ORAL AB RLD 2006-01-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021938-002 SUTENT EQ 25MG BASE CAPSULE / ORAL AB RLD 2006-01-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021938-003 SUTENT EQ 50MG BASE CAPSULE / ORAL AB RLD, RS 2006-01-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021938-004 SUTENT EQ 37.5MG BASE CAPSULE / ORAL AB RLD 2009-03-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021938-001 SUTENT EQ 12.5MG BASE CAPSULE / ORAL AB RLD 2006-01-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021938-002 SUTENT EQ 25MG BASE CAPSULE / ORAL AB RLD 2006-01-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021938-003 SUTENT EQ 50MG BASE CAPSULE / ORAL AB RLD, RS 2006-01-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021938-004 SUTENT EQ 37.5MG BASE CAPSULE / ORAL AB RLD 2009-03-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021938-001 SUTENT EQ 12.5MG BASE CAPSULE / ORAL AB RLD 2006-01-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021938-002 SUTENT EQ 25MG BASE CAPSULE / ORAL AB RLD 2006-01-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021938-003 SUTENT EQ 50MG BASE CAPSULE / ORAL AB RLD, RS 2006-01-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021938-004 SUTENT EQ 37.5MG BASE CAPSULE / ORAL AB RLD 2009-03-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021938-001 SUTENT EQ 12.5MG BASE CAPSULE / ORAL AB RLD 2006-01-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021938-002 SUTENT EQ 25MG BASE CAPSULE / ORAL AB RLD 2006-01-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021938-003 SUTENT EQ 50MG BASE CAPSULE / ORAL AB RLD, RS 2006-01-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021938-004 SUTENT EQ 37.5MG BASE CAPSULE / ORAL AB RLD 2009-03-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021938-001 SUTENT EQ 12.5MG BASE CAPSULE / ORAL AB RLD 2006-01-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021938-002 SUTENT EQ 25MG BASE CAPSULE / ORAL AB RLD 2006-01-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021938-003 SUTENT EQ 50MG BASE CAPSULE / ORAL AB RLD, RS 2006-01-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021938-004 SUTENT EQ 37.5MG BASE CAPSULE / ORAL AB RLD 2009-03-31 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 136 observed states.
Observed Orange Book patent history# Patent history page 1 of 6 · 240 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021938-001 7211600 2020-12-22 U-883 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-001 6573293 2021-02-15 U-1154 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-001 6573293 2021-02-15 U-2171 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-001 7125905 2021-02-15 Drug substance, Drug product 2011-06-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-001 7211600*PED 2021-06-22 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-001 6573293*PED 2021-08-15 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-001 7125905*PED 2021-08-15 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-002 7211600 2020-12-22 U-883 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-002 6573293 2021-02-15 U-1154 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-002 6573293 2021-02-15 U-2171 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-002 7125905 2021-02-15 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-002 7211600*PED 2021-06-22 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-002 6573293*PED 2021-08-15 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-002 7125905*PED 2021-08-15 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-003 7211600 2020-12-22 U-883 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-003 6573293 2021-02-15 U-2171 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-003 6573293 2021-02-15 U-1154 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-003 7125905 2021-02-15 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-003 7211600*PED 2021-06-22 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-003 6573293*PED 2021-08-15 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-003 7125905*PED 2021-08-15 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-004 7211600 2020-12-22 U-883 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-004 6573293 2021-02-15 U-1154 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-004 6573293 2021-02-15 U-2171 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-004 7125905 2021-02-15 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-004 7211600*PED 2021-06-22 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-004 6573293*PED 2021-08-15 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021938-004 7125905*PED 2021-08-15 Pediatric extension 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N021938-001 6573293 2021-02-15 U-1154 Drug substance, Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021938-001 6573293 2021-02-15 U-2171 Drug substance, Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021938-001 7125905 2021-02-15 Drug substance, Drug product 2011-06-17 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021938-001 7211600*PED 2021-06-22 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021938-001 6573293*PED 2021-08-15 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021938-001 7125905*PED 2021-08-15 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021938-002 6573293 2021-02-15 U-2171 Drug substance, Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021938-002 6573293 2021-02-15 U-1154 Drug substance, Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021938-002 7125905 2021-02-15 Drug substance, Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021938-002 7211600*PED 2021-06-22 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021938-002 6573293*PED 2021-08-15 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021938-002 7125905*PED 2021-08-15 Pediatric extension 782e0a99824c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 60 observed states.
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 63539-019-01 SUTENT 14 in 1 BOTTLE CAPSULE 14 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63539-019 SUTENT (SUNITINIB MALATE) CAPSULE [U.S. PHARMACEUTICALS] 5 Current NDC, Legacy NDC, 1 package rows 20250325_a5d555f5-d66a-4f94-abcf-96fa6d71a32f.zip
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 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63539-019-01 63539001901 14 CAPSULE in 1 BOTTLE (63539-019-01) 14 capsule 2017-05-02 0000-00-00 Yes No Current