raloxifene hydrochloride

Orange BookUNIISPLATC G03XC01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA

CountryUS (United States)

ATC codeG03XC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6846239301
100 TABLET, FILM COATED in 1 BOTTLE (68462-393-01)
ndc11
6846239310
1000 TABLET, FILM COATED in 1 BOTTLE (68462-393-10)
ndc11
6846239323
2000 TABLET, FILM COATED in 1 BOTTLE (68462-393-23)
ndc11
6846239330
30 TABLET, FILM COATED in 1 BOTTLE (68462-393-30)
ndc11
6846239390
90 TABLET, FILM COATED in 1 BOTTLE (68462-393-90)

Annotations

UNII (FDA Substance ID)

4F86W47BR6

RALOXIFENE HYDROCHLORIDE

RxCUI 166551

Orange Book

A204491

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": "68462-393_3681932a-8ad0-4486-ae11-efc2f4b3ee96",
  "productndc": "68462-393",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204491",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "001",
        "approval_date": "Mar 22, 2016"
      }
    ],
    "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": "ANDA204491",
  "marketing_category": "ANDA",
  "nonproprietary_name": "raloxifene hydrochloride",
  "start_marketing_date": "20160322",
  "active_numerator_strength": "60"
}

Related drugs

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