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United States · US · US:68382-640_9e44a416-1d3d-418c-a113-f6c65175b564
Dutasteride and tamsulosin hydrochloride
Orange BookUNIISPLATC G04CB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeG04CB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11683826400630 CAPSULE in 1 BOTTLE (68382-640-06)
- ndc11683826401690 CAPSULE in 1 BOTTLE (68382-640-16)
Annotations
UNII (FDA Substance ID)
O0J6XJN02I
DUTASTERIDE
RxCUI 228790
Orange Book
A207769
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": "68382-640_9e44a416-1d3d-418c-a113-f6c65175b564",
"productndc": "68382-640",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "207769",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "0.5MG;0.4MG",
"product_no": "001",
"approval_date": "May 24, 2018"
}
],
"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": "ANDA207769",
"marketing_category": "ANDA",
"nonproprietary_name": "Dutasteride and tamsulosin hydrochloride",
"start_marketing_date": "20180604",
"active_numerator_strength": ".5; .4"
}Related drugs
Other records sharing ATC code G04CB.
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