Home NDC 0069-0770 SUTENT
Product NDC 0069-0770
11-digit product format 000690770
Labeler code 0069
Product ID 0069-0770_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 25 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 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.
Additional Listing Data#
Finished product Yes
Brand name base SUTENT
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SUNITINIB MALATE 25 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 0069-0770-38 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 0069-0770 SUTENT (SUNITINIB MALATE) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC] 48 Current NDC, Legacy NDC, 1 package rows 20250402_43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c.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 ndc (product): 0069-0770
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 0069-0770-38 00069077038 28 CAPSULE in 1 BOTTLE (0069-0770-38) 28 capsule 2006-01-26 0000-00-00 No No Current