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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

  • ndc11
    6818080136
    150 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"
}

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