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United States · US · US:71209-082_14d4c334-b49d-4479-a91e-20b7276b4eca
Raloxifene hydrochloride
Orange BookUNIISPLATC G03XC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCadila Pharmaceuticals Limited
CountryUS (United States)
ATC codeG03XC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11712090820130 TABLET, COATED in 1 BOTTLE (71209-082-01)
- ndc117120908205100 TABLET, COATED in 1 BOTTLE (71209-082-05)
- ndc1171209082111000 TABLET, COATED in 1 BOTTLE (71209-082-11)
- ndc1171209082132000 TABLET, COATED in 1 BOTTLE (71209-082-13)
Annotations
UNII (FDA Substance ID)
4F86W47BR6
RALOXIFENE HYDROCHLORIDE
RxCUI 166551
Orange Book
A211324
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": "71209-082_14d4c334-b49d-4479-a91e-20b7276b4eca",
"productndc": "71209-082",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "211324",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "60MG",
"product_no": "001",
"approval_date": "Aug 18, 2020"
}
],
"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": "ANDA211324",
"marketing_category": "ANDA",
"nonproprietary_name": "Raloxifene hydrochloride",
"start_marketing_date": "20171230",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code G03XC01.
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