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United States · US · US:69097-825_ebab2c47-9350-447a-9372-7ade623d5bb1

Raloxifene Hydrochloride

Orange BookUNIISPLATC G03XC01

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

Identification

ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeG03XC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6909782502
    30 TABLET in 1 BOTTLE (69097-825-02)
  • ndc11
    6909782507
    100 TABLET in 1 BOTTLE (69097-825-07)
  • ndc11
    6909782515
    1000 TABLET in 1 BOTTLE (69097-825-15)

Annotations

UNII (FDA Substance ID)
4F86W47BR6
RALOXIFENE HYDROCHLORIDE
RxCUI 166551
Orange Book
A090842
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": "69097-825_ebab2c47-9350-447a-9372-7ade623d5bb1",
  "productndc": "69097-825",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090842",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "001",
        "approval_date": "Sep 24, 2014"
      }
    ],
    "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": "ANDA090842",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Raloxifene",
  "start_marketing_date": "20160629",
  "active_numerator_strength": "60"
}

Related drugs

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