Home NDC 43598-045 SUNITINIB MALATE
Product NDC 43598-045
11-digit product format 435980045
Labeler code 43598
Product ID 43598-045_664e6a61-82ff-5756-1fc1-9266090d901e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SUNITINIB MALATE
Dosage form CAPSULE
Route ORAL
Labeler Dr.Reddys Laboratories Inc
Application ANDA215843
Marketing category ANDA
Marketing start 2022-11-30
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 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 A215843-001 SUNITINIB MALATE SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2022-04-11 A215843-002 SUNITINIB MALATE SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2022-04-11 A215843-003 SUNITINIB MALATE SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2022-04-11 A215843-004 SUNITINIB MALATE SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2022-04-11
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 3 · 120 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 A215843-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2022-04-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215843-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2022-04-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215843-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2022-04-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215843-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2022-04-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215843-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2022-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215843-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2022-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215843-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2022-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215843-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2022-04-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215843-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2022-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215843-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2022-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215843-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2022-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215843-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2022-04-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215843-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2022-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215843-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2022-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215843-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2022-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215843-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2022-04-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215843-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2022-04-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215843-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2022-04-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215843-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2022-04-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215843-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2022-04-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215843-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2022-04-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215843-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2022-04-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215843-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2022-04-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215843-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2022-04-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215843-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2022-04-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215843-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2022-04-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215843-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2022-04-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215843-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2022-04-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215843-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2022-04-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215843-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2022-04-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215843-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2022-04-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215843-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2022-04-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215843-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2022-04-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215843-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2022-04-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215843-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2022-04-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215843-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2022-04-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215843-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2022-04-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215843-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2022-04-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215843-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2022-04-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215843-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2022-04-11 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 observed states.
Additional Listing Data#
Finished product Yes
Brand name base SUNITINIB MALATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SUNITINIB MALATE 12.5 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 43598-045-28 SUNITINIB MALATE 4 in 1 CARTON CAPSULE 4 5 43598-045-63 SUNITINIB MALATE 28 in 1 BOTTLE CAPSULE 28 5 43598-045-70 SUNITINIB MALATE 7 in 1 BLISTER PACK CAPSULE 7 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-045 SUNITINIB MALATE CAPSULE [DR.REDDYS LABORATORIES INC] 5 Current NDC, Legacy NDC, 3 package rows 20221230_96ce8850-b5ae-382b-8433-04949533af44.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.
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 43598-045-28 43598004528 4 BLISTER PACK in 1 CARTON (43598-045-28) / 7 CAPSULE in 1 BLISTER PACK (43598-045-70) 4 blister pack 2022-11-30 0000-00-00 No No Current 43598-045-63 43598004563 28 CAPSULE in 1 BOTTLE (43598-045-63) 28 capsule 2022-11-30 0000-00-00 No No Current 43598-045-70 43598004570 7 in 1 BLISTER PACK Historical