Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide Tablets, 37.5 mg/ 25 mg and 75 mg/50 mg
Approved
Approval ID
bd6c3495-ec70-908b-482a-a979506659e9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2023
Manufacturers
FDA
Apotex Corp.
DUNS: 845263701
Products 2
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 Code60505-2657
Application NumberANDA071251
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamterene and Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2023
FDA Product Classification
INGREDIENTS (6)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROCHLOROTHIAZIDEActive
Quantity: 50 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
TRIAMTERENEActive
Quantity: 75 mg in 1 1
Code: WS821Z52LQ
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Triamterene and Hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-2656
Application NumberANDA071251
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamterene and Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2023
FDA Product Classification
INGREDIENTS (8)
TRIAMTERENEActive
Quantity: 37.5 mg in 1 1
Code: WS821Z52LQ
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT