Capecitabine

Orange BookUNIISPLATC L01BC06

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeL01BC06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5965120508
120 TABLET in 1 BOTTLE (59651-205-08)
ndc11
5965120510
1 BLISTER PACK in 1 CARTON (59651-205-10) / 10 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

6804DJ8Z9U

CAPECITABINE

RxCUI 194000

Orange Book

A210604

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": "59651-205_aabd86be-2d1e-46dc-a31f-9a3cb28e94f4",
  "productndc": "59651-205",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "210604",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Apr 17, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Apr 17, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CAPECITABINE",
  "proprietary_name": "Capecitabine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210604",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Capecitabine",
  "start_marketing_date": "20180417",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code L01BC06.

Access this data programmatically

Query Capecitabine and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs