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United States · US · US:0480-3237_f259a366-78fc-4919-9bcb-748314a0581c

Lapatinib

Orange BookUNIISPLATC L01EH01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerTeva Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL01EH01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0480323751
    150 TABLET, FILM COATED in 1 BOTTLE (0480-3237-51)

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": "0480-3237_f259a366-78fc-4919-9bcb-748314a0581c",
  "productndc": "0480-3237",
  "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": "20241219",
  "active_numerator_strength": "250"
}

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