Dyrenium
DYRENIUM (triamterene USP) Capsules 50 mg and 100 mg potassium-sparing diuretic
Approved
Approval ID
ebb177c0-d45d-4443-a85a-e76bd9931a42
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 3, 2023
Manufacturers
FDA
Concordia Pharmaceuticals Inc.
DUNS: 815240092
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Triamterene
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59212-002
Application NumberNDA013174
Product Classification
M
Marketing Category
C73594
G
Generic Name
Triamterene
Product Specifications
Route of AdministrationORAL
Effective DateJuly 3, 2023
FDA Product Classification
INGREDIENTS (7)
TRIAMTERENEActive
Quantity: 50 mg in 1 1
Code: WS821Z52LQ
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Triamterene
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59212-003
Application NumberNDA013174
Product Classification
M
Marketing Category
C73594
G
Generic Name
Triamterene
Product Specifications
Route of AdministrationORAL
Effective DateJuly 3, 2023
FDA Product Classification
INGREDIENTS (7)
TRIAMTERENEActive
Quantity: 100 mg in 1 1
Code: WS821Z52LQ
Classification: ACTIB
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT