Raloxifene Hydrochloride

Orange BookUNIISPLATC G03XC01

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeG03XC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6586270901
100 TABLET, FILM COATED in 1 BOTTLE (65862-709-01)
ndc11
6586270903
3 BLISTER PACK in 1 CARTON (65862-709-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-709-10)
ndc11
6586270922
2000 TABLET, FILM COATED in 1 BOTTLE (65862-709-22)
ndc11
6586270930
30 TABLET, FILM COATED in 1 BOTTLE (65862-709-30)
ndc11
6586270999
1000 TABLET, FILM COATED in 1 BOTTLE (65862-709-99)

Annotations

UNII (FDA Substance ID)

4F86W47BR6

RALOXIFENE HYDROCHLORIDE

RxCUI 166551

Orange Book

A204310

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": "65862-709_161df518-c043-4476-968b-d0268ae03fd5",
  "productndc": "65862-709",
  "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

Other records sharing ATC code G03XC01.

Access this data programmatically

Query Raloxifene Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs