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United States · US · US:0078-0671_940eccaf-92b4-4562-8579-24a53c1bc48d
TYKERB
Orange BookUNIISPLATC L01EH01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeL01EH01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110078067119150 TABLET in 1 BOTTLE (0078-0671-19)
Annotations
UNII (FDA Substance ID)
G873GX646R
LAPATINIB DITOSYLATE
RxCUI 481474
Orange Book
N022059
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "G873GX646R",
"rxcui": "481474",
"inchikey": "XNRVGTHNYCNCFF-UHFFFAOYSA-N",
"display_name": "LAPATINIB DITOSYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"eee37f88-ec6a-4c30-b8aa-e2c71f93088c": {
"match": "brand_token",
"title": "TYKERB (LAPATINIB) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]",
"spl_version": "14",
"published_date": "2026-01-28"
}
},
"productid": "0078-0671_940eccaf-92b4-4562-8579-24a53c1bc48d",
"productndc": "0078-0671",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "022059",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 250MG BASE",
"product_no": "001",
"approval_date": "Mar 13, 2007"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LAPATINIB DITOSYLATE",
"proprietary_name": "TYKERB",
"active_ingred_unit": "mg/1",
"application_number": "NDA022059",
"marketing_category": "NDA",
"nonproprietary_name": "lapatinib",
"start_marketing_date": "20160803",
"active_numerator_strength": "250"
}Related drugs
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- 🇺🇸LapatinibLupin Pharmaceuticals, Inc.
- DKLapatinib "Newbury"Newbury Pharmaceuticals AB
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- NLLapatinib PharOS 250 mg, filmomhulde tablettenPharos Pharmaceutical Oriented Services Ltd
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