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United States · US · US:72241-010_f0db29f5-28da-4165-94f8-24727b6b71e5

Raloxifene hydrochloride

Orange BookUNIISPLATC G03XC01

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

Identification

ManufacturerModavar Pharmaceuticals LLC
CountryUS (United States)
ATC codeG03XC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7224101005
    100 TABLET, COATED in 1 BOTTLE (72241-010-05)
  • ndc11
    7224101011
    1000 TABLET, COATED in 1 BOTTLE (72241-010-11)
  • ndc11
    7224101013
    2000 TABLET, COATED in 1 BOTTLE (72241-010-13)
  • ndc11
    7224101022
    30 TABLET, COATED in 1 BOTTLE (72241-010-22)

Annotations

UNII (FDA Substance ID)
4F86W47BR6
RALOXIFENE HYDROCHLORIDE
RxCUI 166551
Orange Book
A211324
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4F86W47BR6",
    "rxcui": "166551",
    "inchikey": "BKXVVCILCIUCLG-UHFFFAOYSA-N",
    "display_name": "RALOXIFENE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "3798c70b-a4b0-4811-9788-e4c9cff47ebe": {
      "match": "brand_token",
      "title": "RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC]",
      "spl_version": "16",
      "published_date": "2026-04-29"
    }
  },
  "productid": "72241-010_f0db29f5-28da-4165-94f8-24727b6b71e5",
  "productndc": "72241-010",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "211324",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "001",
        "approval_date": "Aug 18, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RALOXIFENE HYDROCHLORIDE",
  "proprietary_name": "Raloxifene hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211324",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Raloxifene hydrochloride",
  "start_marketing_date": "20171230",
  "active_numerator_strength": "60"
}

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