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United States · US · US:59651-063_2ad47033-76f3-447d-8a44-21479e9164c0
Dutasteride and Tamsulosin Hydrochloride
Orange BookUNIISPLATC G04CB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeG04CB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11596510633030 CAPSULE in 1 BOTTLE (59651-063-30)
- ndc11596510639090 CAPSULE in 1 BOTTLE (59651-063-90)
Annotations
UNII (FDA Substance ID)
O0J6XJN02I
DUTASTERIDE
RxCUI 228790
Orange Book
A213300
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": "59651-063_2ad47033-76f3-447d-8a44-21479e9164c0",
"productndc": "59651-063",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "213300",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG;0.4MG",
"product_no": "001",
"approval_date": "Jul 18, 2024"
}
],
"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": "ANDA213300",
"marketing_category": "ANDA",
"nonproprietary_name": "Dutasteride and Tamsulosin Hydrochloride",
"start_marketing_date": "20240718",
"active_numerator_strength": ".5; .4"
}Related drugs
Other records sharing ATC code G04CB.
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