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United States · US · US:42806-549_2b367985-feb6-bf97-e063-6294a90aede5
Dutasteride
Orange BookUNIISPLATC G04CB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEpic Pharma, LLC
CountryUS (United States)
ATC codeG04CB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11428065490990 CAPSULE, LIQUID FILLED in 1 BOTTLE (42806-549-09)
- ndc11428065493030 CAPSULE, LIQUID FILLED in 1 BOTTLE (42806-549-30)
Annotations
UNII (FDA Substance ID)
O0J6XJN02I
DUTASTERIDE
RxCUI 228790
Orange Book
A209909
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "O0J6XJN02I",
"rxcui": "228790",
"inchikey": "JWJOTENAMICLJG-QWBYCMEYSA-N",
"display_name": "DUTASTERIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"74f29982-2317-4d31-a324-fe99bd134c31": {
"match": "brand_token",
"title": "DUTASTERIDE CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK]",
"spl_version": "107",
"published_date": "2026-06-01"
}
},
"productid": "42806-549_2b367985-feb6-bf97-e063-6294a90aede5",
"productndc": "42806-549",
"dosage_form": "CAPSULE, LIQUID FILLED",
"orange_book": {
"appl_no": "209909",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "001",
"approval_date": "Nov 21, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DUTASTERIDE",
"proprietary_name": "Dutasteride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA209909",
"marketing_category": "ANDA",
"nonproprietary_name": "Dutasteride",
"start_marketing_date": "20171128",
"active_numerator_strength": ".5"
}Related drugs
Other records sharing ATC code G04CB02.
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