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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
- ndc11690978250230 TABLET in 1 BOTTLE (69097-825-02)
- ndc116909782507100 TABLET in 1 BOTTLE (69097-825-07)
- ndc1169097825151000 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
Other records sharing ATC code G03XC01.
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