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United States · US · US:72205-050_199a7f12-59c6-430f-bc07-a63af2fc7589

toremifene citrate

Orange BookUNIISPLATC L02BA02

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

Identification

ManufacturerNovadoz Pharmaceuticals LLC
CountryUS (United States)
ATC codeL02BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7220505030
    30 TABLET in 1 BOTTLE (72205-050-30)

Annotations

UNII (FDA Substance ID)
2498Y783QT
TOREMIFENE CITRATE
RxCUI 49953
Orange Book
A212818
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": "72205-050_199a7f12-59c6-430f-bc07-a63af2fc7589",
  "productndc": "72205-050",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "212818",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 60MG BASE",
        "product_no": "001",
        "approval_date": "Aug 18, 2020"
      }
    ],
    "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": "ANDA212818",
  "marketing_category": "ANDA",
  "nonproprietary_name": "toremifene citrate",
  "start_marketing_date": "20200902",
  "active_numerator_strength": "60"
}

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