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 42 .
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 2026-08-18 06:07:40 2026-07 A217968-001 LAPATINIB DITOSYLATE EQ 250MG BASE TABLET / ORAL AB 2024-08-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217968-001 LAPATINIB DITOSYLATE EQ 250MG BASE TABLET / ORAL AB 2024-08-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217968-001 LAPATINIB DITOSYLATE EQ 250MG BASE TABLET / ORAL AB 2024-08-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217968-001 LAPATINIB DITOSYLATE EQ 250MG BASE TABLET / ORAL AB 2024-08-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217968-001 LAPATINIB DITOSYLATE EQ 250MG BASE TABLET / ORAL AB 2024-08-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217968-001 LAPATINIB DITOSYLATE EQ 250MG BASE TABLET / ORAL AB 2024-08-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217968-001 LAPATINIB DITOSYLATE EQ 250MG BASE TABLET / ORAL AB 2024-08-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217968-001 LAPATINIB DITOSYLATE EQ 250MG BASE TABLET / ORAL AB 2024-08-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217968-001 LAPATINIB DITOSYLATE EQ 250MG BASE TABLET / ORAL AB 2024-08-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217968-001 LAPATINIB DITOSYLATE EQ 250MG BASE TABLET / ORAL AB 2024-08-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217968-001 LAPATINIB DITOSYLATE EQ 250MG BASE TABLET / ORAL AB 2024-08-16 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217968-001 LAPATINIB DITOSYLATE EQ 250MG BASE TABLET / ORAL AB 2024-08-16 a50c72e98297…
Observed Orange Book normalized TE history# 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
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 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