🇺🇸
United States · US · US:59651-021_cfb5a2a0-be39-4ef5-b115-47ba5a4b7dd3
Dutasteride
Orange BookUNIISPLATC G04CB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeG04CB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11596510213030 CAPSULE, LIQUID FILLED in 1 BOTTLE (59651-021-30)
- ndc11596510219090 CAPSULE, LIQUID FILLED in 1 BOTTLE (59651-021-90)
Annotations
UNII (FDA Substance ID)
O0J6XJN02I
DUTASTERIDE
RxCUI 228790
Orange Book
A202660
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": "59651-021_cfb5a2a0-be39-4ef5-b115-47ba5a4b7dd3",
"productndc": "59651-021",
"dosage_form": "CAPSULE, LIQUID FILLED",
"orange_book": {
"appl_no": "202660",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "001",
"approval_date": "Nov 20, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DUTASTERIDE",
"proprietary_name": "Dutasteride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202660",
"marketing_category": "ANDA",
"nonproprietary_name": "Dutasteride",
"start_marketing_date": "20230120",
"active_numerator_strength": ".5"
}Related drugs
Other records sharing ATC code G04CB02.
Access this data programmatically
Query Dutasteride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.