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United States · US · US:42747-327_11857fbe-6c5e-485e-b5d4-7f091a331928

Fareston

Orange BookUNIISPLATC L02BA02

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

Identification

ManufacturerKyowa Kirin, Inc.
CountryUS (United States)
ATC codeL02BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4274732730
    30 TABLET in 1 BOTTLE (42747-327-30)
  • ndc11
    4274732772
    7 TABLET in 1 BLISTER PACK (42747-327-72)

Annotations

UNII (FDA Substance ID)
2498Y783QT
TOREMIFENE CITRATE
RxCUI 49953
Orange Book
N020497
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2498Y783QT",
    "rxcui": "49953",
    "inchikey": "IWEQQRMGNVVKQW-OQKDUQJOSA-N",
    "display_name": "TOREMIFENE CITRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2cab8dd1-3a10-48e6-86ce-0e5275ed49e5": {
      "match": "brand_token",
      "title": "FARESTON (TOREMIFENE CITRATE) TABLET [KYOWA KIRIN, INC.]",
      "spl_version": "11",
      "published_date": "2024-11-15"
    }
  },
  "productid": "42747-327_11857fbe-6c5e-485e-b5d4-7f091a331928",
  "productndc": "42747-327",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "020497",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 60MG BASE",
        "product_no": "001",
        "approval_date": "May 29, 1997"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TOREMIFENE CITRATE",
  "proprietary_name": "Fareston",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020497",
  "marketing_category": "NDA",
  "nonproprietary_name": "toremifene citrate",
  "start_marketing_date": "19970630",
  "active_numerator_strength": "60"
}

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