Home NDC 42291-904 Sunitinib Malate
Product NDC 42291-904
11-digit product format 422910904
Labeler code 42291
Product ID 42291-904_4884360d-03d2-1af6-e063-6294a90aedf6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sunitinib Malate
Dosage form CAPSULE
Route ORAL
Labeler AvKARE
Application ANDA213803
Marketing category ANDA
Marketing start 2023-10-11
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 A213803-001 SUNITINIB MALATE SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2021-11-30 A213803-002 SUNITINIB MALATE SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2021-11-30 A213803-003 SUNITINIB MALATE SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2021-11-30 A213803-004 SUNITINIB MALATE SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2021-11-30
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 A213803-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2021-11-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A213803-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2021-11-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A213803-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2021-11-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A213803-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2021-11-30 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 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Sunitinib Malate
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 · 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 42291-904-28 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 42291-904 SUNITINIB MALATE CAPSULE [AVKARE] 1 Current NDC, 1 package rows 20231012_0772eb61-ca42-39de-e063-6294a90a6632.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42291-904-28 42291090428 28 CAPSULE in 1 BOTTLE (42291-904-28) 28 capsule 2023-10-11 No No Current