Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide Tablets, 37.5 mg/ 25 mg and 75 mg/50 mg
Approved
Approval ID
5ba2c08b-5ce5-4967-bc3b-2c73df9865af
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 4, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Triamterene and Hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71335-0326
Application NumberANDA071251
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamterene and Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 24, 2022
FDA Product Classification
INGREDIENTS (6)
TRIAMTERENEActive
Quantity: 75 mg in 1 1
Code: WS821Z52LQ
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYDROCHLOROTHIAZIDEActive
Quantity: 50 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB