lapatinib

Generic: lapatinib

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lapatinib
Generic Name lapatinib
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lapatinib ditosylate 250 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-801
Product ID 68180-801_d331d11d-21f4-472c-82d9-3b03b582026a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203007
Listing Expiration 2026-12-31
Marketing Start 2020-09-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180801
Hyphenated Format 68180-801

Supplemental Identifiers

RxCUI
672149
UPC
0368180801368
UNII
G873GX646R

Packaging Origin

Original Packager
true

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 ANDA203007 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 150 TABLET in 1 BOTTLE (68180-801-36)
source: ndc

Packages (1)

68180-801-36 150 TABLET in 1 BOTTLE (68180-801-36)

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": "d331d11d-21f4-472c-82d9-3b03b582026a", "openfda": {"upc": ["0368180801368"], "unii": ["G873GX646R"], "rxcui": ["672149"], "spl_set_id": ["50d0dd0c-7682-43d0-aa1b-ca26e9181aee"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "150 TABLET in 1 BOTTLE (68180-801-36)", "package_ndc": "68180-801-36", "marketing_start_date": "20200929"}], "brand_name": "Lapatinib", "product_id": "68180-801_d331d11d-21f4-472c-82d9-3b03b582026a", "dosage_form": "TABLET", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "68180-801", "generic_name": "lapatinib", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lapatinib", "active_ingredients": [{"name": "LAPATINIB DITOSYLATE", "strength": "250 mg/1"}], "application_number": "ANDA203007", "marketing_category": "ANDA", "marketing_start_date": "20200929", "listing_expiration_date": "20261231"}