Dutasteride

Product NDC
72578-019
11-digit product format
725780019
Labeler code
72578
Product ID
72578-019_59a26e95-6ed5-4648-9bf6-f0189e4f1c32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dutasteride
Dosage form
CAPSULE
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA204373
Marketing category
ANDA
Marketing start
2019-04-15
Marketing end
0000-00-00
Substance
DUTASTERIDE
Active strength
1 mg/1
Pharmacologic classes
5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-019DUTASTERIDE CAPSULE [VIONA PHARMACEUTICALS INC]3Legacy NDC20241113_f57c7ab3-3345-48e8-83cb-bec02da3d23c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72578-019-067257800190630 CAPSULE in 1 BOTTLE (72578-019-06) 30 capsule2019-04-150000-00-00NoNoCurrent
72578-019-167257800191690 CAPSULE in 1 BOTTLE (72578-019-16) 90 capsule2019-04-150000-00-00NoNoCurrent