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United States · US · US:84091-100_372f7766-bcc0-4eaa-8593-e29c0c6dcff7
DUTASTERIDE
Orange BookUNIISPLATC G04CB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBanyan Pharma LLC
CountryUS (United States)
ATC codeG04CB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11840911009090 CAPSULE in 1 BOTTLE (84091-100-90)
Annotations
UNII (FDA Substance ID)
O0J6XJN02I
DUTASTERIDE
RxCUI 228790
Orange Book
A204705
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": "84091-100_372f7766-bcc0-4eaa-8593-e29c0c6dcff7",
"productndc": "84091-100",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "204705",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "0.5MG",
"product_no": "001",
"approval_date": "Nov 20, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DUTASTERIDE",
"proprietary_name": "DUTASTERIDE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204705",
"marketing_category": "ANDA",
"nonproprietary_name": "DUTASTERIDE",
"start_marketing_date": "20251231",
"active_numerator_strength": ".5"
}Related drugs
Other records sharing ATC code G04CB02.
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