capecitabine

Orange BookUNIISPLATC L01BC06

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

Identification

ManufacturerDr. Reddy's Laboratories Limited

CountryUS (United States)

ATC codeL01BC06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5511149704
120 TABLET in 1 BOTTLE (55111-497-04)
ndc11
5511149705
500 TABLET in 1 BOTTLE (55111-497-05)

Annotations

UNII (FDA Substance ID)

6804DJ8Z9U

CAPECITABINE

RxCUI 194000

Orange Book

A204345

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": "55111-497_25eb47d5-42ca-889b-6798-6f91d7795417",
  "productndc": "55111-497",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204345",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Dec 4, 2020"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Dec 4, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CAPECITABINE",
  "proprietary_name": "capecitabine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204345",
  "marketing_category": "ANDA",
  "nonproprietary_name": "capecitabine",
  "start_marketing_date": "20201210",
  "active_numerator_strength": "500"
}

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