XELODA

Orange BookUNIISPLATC L01BC06

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerH2-Pharma, LLC

CountryUS (United States)

ATC codeL01BC06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6126947512
120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61269-475-12)

Annotations

UNII (FDA Substance ID)

6804DJ8Z9U

CAPECITABINE

RxCUI 194000

Orange Book

N020896

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "6804DJ8Z9U",
    "rxcui": "194000",
    "inchikey": "GAGWJHPBXLXJQN-UORFTKCHSA-N",
    "display_name": "CAPECITABINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e702d84d-7162-4751-bf37-d724cc7e45a5": {
      "match": "brand_token",
      "title": "XELODA (CAPECITABINE) TABLET, FILM COATED [H2-PHARMA, LLC]",
      "spl_version": "32",
      "published_date": "2026-02-06"
    }
  },
  "productid": "61269-475_32dd0155-c5cb-49c2-9b74-74f40df22df7",
  "productndc": "61269-475",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020896",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Apr 30, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Apr 30, 1998"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CAPECITABINE",
  "proprietary_name": "XELODA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020896",
  "marketing_category": "NDA",
  "nonproprietary_name": "capecitabine",
  "start_marketing_date": "19980430",
  "active_numerator_strength": "500"
}

Related drugs

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