Capecitabine

Orange BookUNIISPLATC L01BC06

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeL01BC06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6275623918
1000 TABLET, FILM COATED in 1 BOTTLE (62756-239-18)
ndc11
6275623920
120 TABLET, FILM COATED in 1 BOTTLE (62756-239-20)
ndc11
6275623983
30 TABLET, FILM COATED in 1 BOTTLE (62756-239-83)

Annotations

UNII (FDA Substance ID)

6804DJ8Z9U

CAPECITABINE

RxCUI 194000

Orange Book

A204668

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": "62756-239_8a24ef3b-b59a-4051-bf0d-a98eb6187ef2",
  "productndc": "62756-239",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204668",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Jun 21, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Jun 21, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CAPECITABINE",
  "proprietary_name": "Capecitabine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204668",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Capecitabine",
  "start_marketing_date": "20190901",
  "active_numerator_strength": "500"
}

Related drugs

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