lapatinib

Generic: lapatinib

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lapatinib
Generic Name lapatinib
Labeler avkare
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lapatinib ditosylate 250 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-035
Product ID 42291-035_302a4314-e1d6-3ce6-e063-6394a90a75a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217968
Listing Expiration 2026-12-31
Marketing Start 2025-03-12

Pharmacologic Class

Classes
kinase inhibitor [epc] protein kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291035
Hyphenated Format 42291-035

Supplemental Identifiers

RxCUI
672149
UPC
0342291035157
UNII
G873GX646R

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lapatinib (source: ndc)
Generic Name lapatinib (source: ndc)
Application Number ANDA217968 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 150 TABLET, FILM COATED in 1 BOTTLE (42291-035-15)
source: ndc

Packages (1)

42291-035-15 150 TABLET, FILM COATED in 1 BOTTLE (42291-035-15)

Ingredients (1)

lapatinib ditosylate (250 mg/1)

Linked Drug Pages (1)

Lapatinib ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "302a4314-e1d6-3ce6-e063-6394a90a75a1", "openfda": {"upc": ["0342291035157"], "unii": ["G873GX646R"], "rxcui": ["672149"], "spl_set_id": ["302a4346-a68d-af3e-e063-6294a90a4a6f"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "150 TABLET, FILM COATED in 1 BOTTLE (42291-035-15)", "package_ndc": "42291-035-15", "marketing_start_date": "20250312"}], "brand_name": "Lapatinib", "product_id": "42291-035_302a4314-e1d6-3ce6-e063-6394a90a75a1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "42291-035", "generic_name": "Lapatinib", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lapatinib", "active_ingredients": [{"name": "LAPATINIB DITOSYLATE", "strength": "250 mg/1"}], "application_number": "ANDA217968", "marketing_category": "ANDA", "marketing_start_date": "20250312", "listing_expiration_date": "20261231"}