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United States · US · US:42291-035_302a4314-e1d6-3ce6-e063-6394a90a75a1
Lapatinib
Orange BookUNIISPLATC L01EH01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAvKARE
CountryUS (United States)
ATC codeL01EH01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc114229103515150 TABLET, FILM COATED in 1 BOTTLE (42291-035-15)
Annotations
UNII (FDA Substance ID)
G873GX646R
LAPATINIB DITOSYLATE
RxCUI 481474
Orange Book
A217968
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": {
"50d0dd0c-7682-43d0-aa1b-ca26e9181aee": {
"match": "brand_token",
"title": "LAPATINIB TABLET [LUPIN PHARMACEUTICALS, INC. ]",
"spl_version": "4",
"published_date": "2025-06-16"
}
},
"productid": "42291-035_302a4314-e1d6-3ce6-e063-6394a90a75a1",
"productndc": "42291-035",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "217968",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 250MG BASE",
"product_no": "001",
"approval_date": "Aug 16, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LAPATINIB DITOSYLATE",
"proprietary_name": "Lapatinib",
"active_ingred_unit": "mg/1",
"application_number": "ANDA217968",
"marketing_category": "ANDA",
"nonproprietary_name": "Lapatinib",
"start_marketing_date": "20250312",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code L01EH01.
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- 🇺🇸LapatinibLupin Pharmaceuticals, Inc.
- DKLapatinib "Newbury"Newbury Pharmaceuticals AB
- ISLapatinib NewburyNewbury Pharmaceuticals AB
- NLLapatinib PharOS 250 mg, filmomhulde tablettenPharos Pharmaceutical Oriented Services Ltd
- 🇪🇸LAPATINIB STADA 250 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGLaboratorio Stada S.L.
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