Home NDC 42291-035 Lapatinib
Product NDC 42291-035
11-digit product format 422910035
Labeler code 42291
Product ID 42291-035_302a4314-e1d6-3ce6-e063-6394a90a75a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lapatinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AvKARE
Application ANDA217968
Marketing category ANDA
Marketing start 2025-03-12
Substance LAPATINIB DITOSYLATE
Active strength 250 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 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217968-001 LAPATINIB DITOSYLATE LAPATINIB DITOSYLATE EQ 250MG BASE TABLET / ORAL AB 2024-08-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217968-001 AB
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 A217968-001 LAPATINIB DITOSYLATE EQ 250MG BASE TABLET / ORAL AB 2024-08-16 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A217968-001 AB 1 a50c72e98297…
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 Lapatinib
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LAPATINIB DITOSYLATE 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G873GX646R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 672149 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 42291-035-15 Lapatinib 150 in 1 BOTTLE TABLET, FILM COATED 150 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-035 LAPATINIB TABLET, FILM COATED [AVKARE] 1 Current NDC, 1 package rows 20250315_302a4346-a68d-af3e-e063-6294a90a4a6f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 42291-035-15 42291003515 150 TABLET, FILM COATED in 1 BOTTLE (42291-035-15) 2025-03-12 No No Current