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United States · US · US:80725-712_52039b4d-0202-4d5b-8790-352d254525d1
AVODART
Orange BookUNIISPLATC G04CB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWaylis Therapeutics LLC
CountryUS (United States)
ATC codeG04CB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11807257120490 CAPSULE, LIQUID FILLED in 1 BOTTLE (80725-712-04)
- ndc11807257121530 CAPSULE, LIQUID FILLED in 1 BOTTLE (80725-712-15)
Annotations
UNII (FDA Substance ID)
O0J6XJN02I
DUTASTERIDE
RxCUI 228790
Orange Book
N021319
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": {
"960797b3-09b1-4d6a-8ece-8b5d918e93e4": {
"match": "brand_token",
"title": "AVODART (DUTASTERIDE) CAPSULE, LIQUID FILLED [WAYLIS THERAPEUTICS LLC]",
"spl_version": "4",
"published_date": "2025-03-17"
}
},
"productid": "80725-712_52039b4d-0202-4d5b-8790-352d254525d1",
"productndc": "80725-712",
"dosage_form": "CAPSULE, LIQUID FILLED",
"orange_book": {
"appl_no": "021319",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "001",
"approval_date": "Nov 20, 2001"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DUTASTERIDE",
"proprietary_name": "AVODART",
"active_ingred_unit": "mg/1",
"application_number": "NDA021319",
"marketing_category": "NDA",
"nonproprietary_name": "dutasteride",
"start_marketing_date": "20221215",
"active_numerator_strength": ".5"
}Related drugs
Other records sharing ATC code G04CB02.
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