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United States · US · US:10370-280_79eff189-e6e9-477e-beb6-568046fb5043
Dutasteride and Tamsulosin Hydrochloride
Orange BookUNIISPLATC G04CB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEndo USA, Inc.
CountryUS (United States)
ATC codeG04CB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11103702800990 CAPSULE in 1 BOTTLE (10370-280-09)
- ndc11103702801130 CAPSULE in 1 BOTTLE (10370-280-11)
Annotations
UNII (FDA Substance ID)
O0J6XJN02I
DUTASTERIDE
RxCUI 228790
Orange Book
A202509
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": "10370-280_79eff189-e6e9-477e-beb6-568046fb5043",
"productndc": "10370-280",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "202509",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG;0.4MG",
"product_no": "001",
"approval_date": "Feb 26, 2014"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE",
"proprietary_name": "Dutasteride and Tamsulosin Hydrochloride",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA202509",
"marketing_category": "ANDA",
"nonproprietary_name": "Dutasteride and Tamsulosin Hydrochloride",
"start_marketing_date": "20151118",
"active_numerator_strength": ".5; .4"
}Related drugs
Other records sharing ATC code G04CB.
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