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United States · US · US:68180-801_d331d11d-21f4-472c-82d9-3b03b582026a
Lapatinib
Orange BookUNIISPLATC L01EH01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL01EH01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116818080136150 TABLET in 1 BOTTLE (68180-801-36)
Annotations
UNII (FDA Substance ID)
G873GX646R
LAPATINIB DITOSYLATE
RxCUI 481474
Orange Book
A203007
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": "68180-801_d331d11d-21f4-472c-82d9-3b03b582026a",
"productndc": "68180-801",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "203007",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 250MG BASE",
"product_no": "001",
"approval_date": "Sep 29, 2020"
}
],
"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": "ANDA203007",
"marketing_category": "ANDA",
"nonproprietary_name": "lapatinib",
"start_marketing_date": "20200929",
"active_numerator_strength": "250"
}Related drugs
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