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United States · US · US:0093-7290_3641edbc-4bae-45d0-8afb-8db02f401f66
Raloxifene Hydrochloride
Orange BookUNIISPLATC G03XC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeG03XC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc110093729001100 TABLET, FILM COATED in 1 BOTTLE (0093-7290-01)
- ndc11009372905630 TABLET, FILM COATED in 1 BOTTLE (0093-7290-56)
Annotations
UNII (FDA Substance ID)
4F86W47BR6
RALOXIFENE HYDROCHLORIDE
RxCUI 166551
Orange Book
A078193
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": "0093-7290_3641edbc-4bae-45d0-8afb-8db02f401f66",
"productndc": "0093-7290",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078193",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "60MG",
"product_no": "001",
"approval_date": "Mar 4, 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": "ANDA078193",
"marketing_category": "ANDA",
"nonproprietary_name": "Raloxifene Hydrochloride",
"start_marketing_date": "20140328",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code G03XC01.
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