🇺🇸
United States · US · US:80725-809_bc6c62ea-da7b-4c27-a88e-c80cfcd7856d
Jalyn
Orange BookUNIISPLATC G04CB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWaylis Therapeutics
CountryUS (United States)
ATC codeG04CB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11807258091330 CAPSULE in 1 BOTTLE, PLASTIC (80725-809-13)
- ndc11807258095990 CAPSULE in 1 BOTTLE, PLASTIC (80725-809-59)
Annotations
UNII (FDA Substance ID)
O0J6XJN02I
DUTASTERIDE
RxCUI 228790
Orange Book
N022460
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": {
"aab9a2d4-5328-40f3-986f-e7753a928bc0": {
"match": "brand_token",
"title": "JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [WAYLIS THERAPEUTICS]",
"spl_version": "4",
"published_date": "2026-03-11"
}
},
"productid": "80725-809_bc6c62ea-da7b-4c27-a88e-c80cfcd7856d",
"productndc": "80725-809",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "022460",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "0.5MG;0.4MG",
"product_no": "001",
"approval_date": "Jun 14, 2010"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE",
"proprietary_name": "Jalyn",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA022460",
"marketing_category": "NDA",
"nonproprietary_name": "DUTASTERIDE and TAMSULOSIN HYDROCHLORIDE",
"start_marketing_date": "20240301",
"active_numerator_strength": ".5; .4"
}Related drugs
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