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United States · US · US:16714-213_145e48c3-0ef5-41f7-adc2-ab0a7ca89d87
Raloxifene Hydrochloride
Orange BookUNIISPLATC G03XC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNorthStar Rx LLC
CountryUS (United States)
ATC codeG03XC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11167142130130 TABLET, FILM COATED in 1 BOTTLE (16714-213-01)
- ndc111671421302100 TABLET, FILM COATED in 1 BOTTLE (16714-213-02)
- ndc1116714213031000 TABLET, FILM COATED in 1 BOTTLE (16714-213-03)
Annotations
UNII (FDA Substance ID)
4F86W47BR6
RALOXIFENE HYDROCHLORIDE
RxCUI 166551
Orange Book
A204310
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": "16714-213_145e48c3-0ef5-41f7-adc2-ab0a7ca89d87",
"productndc": "16714-213",
"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.
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