Dyrenium
DYRENIUM (triamterene USP) Capsules 50 mg and 100 mg potassium-sparing diuretic
Approved
Approval ID
ffe24e3d-cfe8-4d5a-8213-69f0bbc9f4d5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 6, 2017
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
Products 1
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 Code68151-1494
Application NumberNDA013174
Product Classification
M
Marketing Category
C73594
G
Generic Name
Triamterene
Product Specifications
Route of AdministrationORAL
Effective DateApril 29, 2015
FDA Product Classification
INGREDIENTS (9)
TRIAMTERENEActive
Quantity: 50 mg in 1 1
Code: WS821Z52LQ
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT