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United States · US · US:63629-8207_b9adcc68-e71a-4805-aa88-80d2d4ddfcbc
Dutasteride
Orange BookUNIISPLATC G04CB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeG04CB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11636298207130 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8207-1)
- ndc11636298207290 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8207-2)
- ndc116362982073180 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8207-3)
Annotations
UNII (FDA Substance ID)
O0J6XJN02I
DUTASTERIDE
RxCUI 228790
Orange Book
A206574
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": "63629-8207_b9adcc68-e71a-4805-aa88-80d2d4ddfcbc",
"productndc": "63629-8207",
"dosage_form": "CAPSULE, LIQUID FILLED",
"orange_book": {
"appl_no": "206574",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "001",
"approval_date": "Oct 21, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DUTASTERIDE",
"proprietary_name": "Dutasteride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206574",
"marketing_category": "ANDA",
"nonproprietary_name": "Dutasteride",
"start_marketing_date": "20161024",
"active_numerator_strength": ".5"
}Related drugs
Other records sharing ATC code G04CB02.
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