Raloxifene Hydrochloride

Orange BookUNIISPLATC G03XC01

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

Identification

ManufacturerAmneal Pharmaceuticals LLC

CountryUS (United States)

ATC codeG03XC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6516205703
30 TABLET, FILM COATED in 1 BOTTLE (65162-057-03)
ndc11
6516205709
90 TABLET, FILM COATED in 1 BOTTLE (65162-057-09)
ndc11
6516205710
100 TABLET, FILM COATED in 1 BOTTLE (65162-057-10)
ndc11
6516205711
1000 TABLET, FILM COATED in 1 BOTTLE (65162-057-11)
ndc11
6516205733
2000 TABLET, FILM COATED in 1 BOTTLE (65162-057-33)
ndc11
6516205750
500 TABLET, FILM COATED in 1 BOTTLE (65162-057-50)

Annotations

UNII (FDA Substance ID)

4F86W47BR6

RALOXIFENE HYDROCHLORIDE

RxCUI 166551

Orange Book

A208206

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": "65162-057_6c80d57b-e265-43cb-a781-6299ea73dccf",
  "productndc": "65162-057",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208206",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "001",
        "approval_date": "Apr 8, 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": "ANDA208206",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Raloxifene Hydrochloride",
  "start_marketing_date": "20160120",
  "active_numerator_strength": "60"
}

Related drugs

Other records sharing ATC code G03XC01.

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