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United States · US · US:72485-205_dad6f70f-70c9-4152-bd36-9cb3537239da

Capecitabine 500mg

Orange BookUNIISPLATC L01BC06

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

Identification

ManufacturerArmas Pharmaceuticals Inc.
CountryUS (United States)
ATC codeL01BC06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7248520512
    1 BOTTLE in 1 CARTON (72485-205-12) / 120 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
6804DJ8Z9U
CAPECITABINE
RxCUI 194000
Orange Book
A207456
ABAB
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": {
    "3e7d6317-1439-4976-ae00-6f62619ec3dd": {
      "match": "brand_token",
      "title": "CAPECITABINE (CAPECITABINE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]",
      "spl_version": "3",
      "published_date": "2026-05-13"
    }
  },
  "productid": "72485-205_dad6f70f-70c9-4152-bd36-9cb3537239da",
  "productndc": "72485-205",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "207456",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Dec 12, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Dec 12, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CAPECITABINE",
  "proprietary_name": "Capecitabine 500mg",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207456",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Capecitabine",
  "start_marketing_date": "20190301",
  "active_numerator_strength": "500"
}

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