Dutasteride
These highlights do not include all the information needed to use DUTASTERIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE CAPSULES.DUTASTERIDE capsules, for oral useInitial U.S. Approval: 2001
Approved
Approval ID
c78d18cf-05df-4154-b2f9-39cc374ca9e3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2021
Manufacturers
FDA
Strides Pharma Science Limited
DUNS: 650738743
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 Code64380-763
Application NumberANDA204262
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dutasteride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2021
FDA Product Classification
INGREDIENTS (12)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
DUTASTERIDEActive
Quantity: 0.5 mg in 1 1
Code: O0J6XJN02I
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GLYCERYL CAPRYLOCAPRATEInactive
Code: U72Q2I8C85
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT