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United States · US · US:25000-011_85bb4dcb-29f9-4490-b88a-725183e258e7
Dutasteride
Orange BookUNIISPLATC G04CB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMARKSANS PHARMA LIMITED
CountryUS (United States)
ATC codeG04CB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11250000110330 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-011-03)
- ndc11250000110790 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-011-07)
- ndc1125000011274 BAG in 1 BOX (25000-011-27) / 2500 CAPSULE, LIQUID FILLED in 1 BAG
Annotations
UNII (FDA Substance ID)
O0J6XJN02I
DUTASTERIDE
RxCUI 228790
Orange Book
A204376
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": "25000-011_85bb4dcb-29f9-4490-b88a-725183e258e7",
"productndc": "25000-011",
"dosage_form": "CAPSULE, LIQUID FILLED",
"orange_book": {
"appl_no": "204376",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "001",
"approval_date": "Apr 7, 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": "ANDA204376",
"marketing_category": "ANDA",
"nonproprietary_name": "Dutasteride",
"start_marketing_date": "20170427",
"active_numerator_strength": ".5"
}Related drugs
Other records sharing ATC code G04CB02.
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