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United States · US · US:55494-580_2e1f0dd2-9e5b-413e-e063-6294a90a636a
Osphena
Orange BookUNIISPLATC G03XC05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDuchesnay USA, Inc.
CountryUS (United States)
ATC codeG03XC05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1155494580181 BLISTER PACK in 1 PACKAGE (55494-580-18) / 15 TABLET, FILM COATED in 1 BLISTER PACK
- ndc11554945803030 TABLET, FILM COATED in 1 BOTTLE (55494-580-30)
- ndc1155494580551 BLISTER PACK in 1 PACKAGE (55494-580-55) / 5 TABLET, FILM COATED in 1 BLISTER PACK
- ndc11554945809090 TABLET, FILM COATED in 1 BOTTLE (55494-580-90)
Annotations
UNII (FDA Substance ID)
B0P231ILBK
OSPEMIFENE
RxCUI 1370971
Orange Book
N203505
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "B0P231ILBK",
"rxcui": "1370971",
"inchikey": "LUMKNAVTFCDUIE-VHXPQNKSSA-N",
"display_name": "OSPEMIFENE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"9accbcc9-78ee-4f84-9b7e-704f2ab1c413": {
"match": "brand_token",
"title": "OSPHENA (OSPEMIFENE) TABLET, FILM COATED [DUCHESNAY USA, INC.]",
"spl_version": "4",
"published_date": "2025-02-17"
}
},
"productid": "55494-580_2e1f0dd2-9e5b-413e-e063-6294a90a636a",
"productndc": "55494-580",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "203505",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "60MG",
"product_no": "001",
"approval_date": "Feb 26, 2013"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OSPEMIFENE",
"proprietary_name": "Osphena",
"active_ingred_unit": "mg/1",
"application_number": "NDA203505",
"marketing_category": "NDA",
"nonproprietary_name": "Ospemifene",
"start_marketing_date": "20230401",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code G03XC05.
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