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United States · US · US:43598-505_f08636b3-11f2-23f1-e053-2a95a90a12e5
Raloxifene hydrochloride
Orange BookUNIISPLATC G03XC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr.Reddy�s Laboratories Inc
CountryUS (United States)
ATC codeG03XC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc114359850501100 TABLET, FILM COATED in 1 BOTTLE (43598-505-01)
- ndc1143598505101000 TABLET, FILM COATED in 1 BOTTLE (43598-505-10)
- ndc11435985053030 TABLET, FILM COATED in 1 BOTTLE (43598-505-30)
Annotations
UNII (FDA Substance ID)
4F86W47BR6
RALOXIFENE HYDROCHLORIDE
RxCUI 166551
Orange Book
A206384
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": "43598-505_f08636b3-11f2-23f1-e053-2a95a90a12e5",
"productndc": "43598-505",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "206384",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "60MG",
"product_no": "001",
"approval_date": "Oct 12, 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": "ANDA206384",
"marketing_category": "ANDA",
"nonproprietary_name": "Raloxifene hydrochloride",
"start_marketing_date": "20161012",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code G03XC01.
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