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United States · US · US:65162-750_d1ac003d-2e58-4a30-8072-8419e7ebb4c6
Dutasteride
Orange BookUNIISPLATC G04CB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeG04CB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11651627500330 CAPSULE in 1 BOTTLE (65162-750-03)
- ndc11651627500990 CAPSULE in 1 BOTTLE (65162-750-09)
Annotations
UNII (FDA Substance ID)
O0J6XJN02I
DUTASTERIDE
RxCUI 228790
Orange Book
A203118
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": "65162-750_d1ac003d-2e58-4a30-8072-8419e7ebb4c6",
"productndc": "65162-750",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "203118",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"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": "ANDA203118",
"marketing_category": "ANDA",
"nonproprietary_name": "Dutasteride",
"start_marketing_date": "20151102",
"active_numerator_strength": ".5"
}Related drugs
Other records sharing ATC code G04CB02.
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