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United States · US · US:71335-2059_7a2ab3a6-eba9-4ac6-ba53-3940b614102d

Raloxifene Hydrochloride

Orange BookUNIISPLATC G03XC01

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeG03XC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7133520591
    60 TABLET, FILM COATED in 1 BOTTLE (71335-2059-1)
  • ndc11
    7133520592
    30 TABLET, FILM COATED in 1 BOTTLE (71335-2059-2)

Annotations

UNII (FDA Substance ID)
4F86W47BR6
RALOXIFENE HYDROCHLORIDE
RxCUI 166551
Orange Book
A204310
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": "71335-2059_7a2ab3a6-eba9-4ac6-ba53-3940b614102d",
  "productndc": "71335-2059",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204310",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "001",
        "approval_date": "Aug 28, 2015"
      }
    ],
    "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": "ANDA204310",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Raloxifene Hydrochloride",
  "start_marketing_date": "20150828",
  "active_numerator_strength": "60"
}

Related drugs

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