Dutasteride
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2001
Approved
Approval ID
047872d2-6621-4ff0-9bb8-88595bc7691f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 29, 2018
Manufacturers
FDA
PuraCap Pharmaceutical LLC
DUNS: 962106329
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dutasteride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51013-190
Application NumberANDA209909
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dutasteride
Product Specifications
Route of AdministrationORAL
Effective DateMay 29, 2018
FDA Product Classification
INGREDIENTS (15)
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
DUTASTERIDEActive
Quantity: 0.5 mg in 1 1
Code: O0J6XJN02I
Classification: ACTIB
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
CAPRYLIC/CAPRIC MONO/DIGLYCERIDESInactive
Code: U72Q2I8C85
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Drug Labeling Information
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 6/30/2017
RECENT MAJOR CHANGES
Warnings and Precautions, Evaluation for Other Urological Diseases (5.3) 03/2012