Home NDC 16714-678 Sunitinib malate
Product NDC 16714-678
11-digit product format 167140678
Labeler code 16714
Product ID 16714-678_2a3c27a8-20ee-4a18-e063-6294a90acd54
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sunitinib malate
Dosage form CAPSULE
Route ORAL
Labeler NorthStar RxLLC
Application ANDA213914
Marketing category ANDA
Marketing start 2022-02-18
Marketing end 2026-09-30
Substance SUNITINIB MALATE
Active strength 37.5 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 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 A213914-001 SUNITINIB MALATE SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2021-08-16 A213914-002 SUNITINIB MALATE SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2021-08-16 A213914-003 SUNITINIB MALATE SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2021-08-16 A213914-004 SUNITINIB MALATE SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2021-08-16
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 4 · 136 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 A213914-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2021-08-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213914-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2021-08-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213914-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2021-08-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213914-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2021-08-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213914-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2021-08-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213914-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2021-08-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213914-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2021-08-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213914-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2021-08-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213914-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2021-08-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213914-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2021-08-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213914-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2021-08-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213914-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2021-08-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213914-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2021-08-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213914-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2021-08-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213914-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2021-08-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213914-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2021-08-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213914-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2021-08-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213914-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2021-08-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213914-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2021-08-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213914-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2021-08-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213914-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2021-08-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213914-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2021-08-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213914-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2021-08-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213914-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2021-08-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213914-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2021-08-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213914-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2021-08-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213914-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2021-08-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213914-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2021-08-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213914-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2021-08-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213914-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2021-08-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213914-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2021-08-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213914-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2021-08-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213914-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2021-08-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213914-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2021-08-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213914-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2021-08-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213914-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2021-08-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213914-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2021-08-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213914-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2021-08-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213914-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2021-08-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213914-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2021-08-16 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 136 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Sunitinib malate Active Ingredients# Ingredient, Strength table Ingredient Strength SUNITINIB MALATE 37.5 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 616279 Internal RxNorm lookup 616285 Internal RxNorm lookup 616289 Internal RxNorm lookup 1541890 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 16714-678-01 Sunitinib malate 28 in 1 BOTTLE CAPSULE 28 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-678 SUNITINIB MALATE CAPSULE [NORTHSTAR RXLLC] 2 Current NDC, Legacy NDC, 1 package rows 20241228_7579e3d0-2de6-4239-a7a8-118ed92075f5.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 · 2 matching rows.
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 16714-678-01 16714067801 28 CAPSULE in 1 BOTTLE (16714-678-01) 28 capsule 2022-02-18 0000-00-00 No No Current