tykerb

Generic: lapatinib

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tykerb
Generic Name lapatinib
Labeler novartis pharmaceuticals corporation
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lapatinib ditosylate 250 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0671
Product ID 0078-0671_940eccaf-92b4-4562-8579-24a53c1bc48d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022059
Listing Expiration 2027-12-31
Marketing Start 2016-08-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00780671
Hyphenated Format 0078-0671

Supplemental Identifiers

RxCUI
672149 672152
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 tykerb (source: ndc)
Generic Name lapatinib (source: ndc)
Application Number NDA022059 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 150 TABLET in 1 BOTTLE (0078-0671-19)
source: ndc

Packages (1)

0078-0671-19 150 TABLET in 1 BOTTLE (0078-0671-19)

Ingredients (1)

lapatinib ditosylate (250 mg/1)

Linked Drug Pages (1)

TYKERB ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "940eccaf-92b4-4562-8579-24a53c1bc48d", "openfda": {"unii": ["G873GX646R"], "rxcui": ["672149", "672152"], "spl_set_id": ["eee37f88-ec6a-4c30-b8aa-e2c71f93088c"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "150 TABLET in 1 BOTTLE (0078-0671-19)", "package_ndc": "0078-0671-19", "marketing_start_date": "20160803"}], "brand_name": "TYKERB", "product_id": "0078-0671_940eccaf-92b4-4562-8579-24a53c1bc48d", "dosage_form": "TABLET", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "0078-0671", "generic_name": "lapatinib", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TYKERB", "active_ingredients": [{"name": "LAPATINIB DITOSYLATE", "strength": "250 mg/1"}], "application_number": "NDA022059", "marketing_category": "NDA", "marketing_start_date": "20160803", "listing_expiration_date": "20271231"}