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United States · US · US:64980-404_6aa927e6-a0b9-4904-aa11-e5a3f52cee47

toremifene citrate

Orange BookUNIISPLATC L02BA02

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

Identification

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

Packs · 1

  • ndc11
    6498040403
    30 TABLET in 1 BOTTLE, PLASTIC (64980-404-03)

Annotations

UNII (FDA Substance ID)
2498Y783QT
TOREMIFENE CITRATE
RxCUI 49953
Orange Book
A208813
AB
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": {
    "e897546b-4136-4cb5-a262-d94cf3fa3298": {
      "match": "brand_token",
      "title": "TOREMIFENE CITRATE TABLET [NOVADOZ PHARMACEUTICALS LLC]",
      "spl_version": "2",
      "published_date": "2025-09-25"
    }
  },
  "productid": "64980-404_6aa927e6-a0b9-4904-aa11-e5a3f52cee47",
  "productndc": "64980-404",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208813",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 60MG BASE",
        "product_no": "001",
        "approval_date": "Dec 4, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TOREMIFENE CITRATE",
  "proprietary_name": "toremifene citrate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208813",
  "marketing_category": "ANDA",
  "nonproprietary_name": "toremifene citrate",
  "start_marketing_date": "20190118",
  "active_numerator_strength": "60"
}

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