Dutasteride

Product NDC
50090-7305
11-digit product format
500907305
Labeler code
50090
Product ID
50090-7305_c9fdff9e-14e3-4d2a-80d2-8c93ed67b459
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dutasteride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202660
Marketing category
ANDA
Marketing start
2023-01-20
Substance
DUTASTERIDE
Active strength
.5 mg/1
Pharmacologic classes
5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
O0J6XJN02IDUTASTERIDE164656-23-9DUTASTERIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7305-05009073050030 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-7305-0) 2024-10-14NoNoHistorical
50090-7305-15009073050190 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-7305-1) 2024-10-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
DutasterideA-S Medication Solutions2024-10-21Human Prescription Drug Label5