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Triamterene

Triamterene Capsule, USP Potassium-Sparing Diuretic

Approved
Approval ID

fea50328-b3d5-4300-8c67-82cda0a975b7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 7, 2023

Manufacturers
FDA

TRUPHARMA LLC

DUNS: 078533947

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Triamterene Capsules

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code52817-365
Application NumberANDA211581
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamterene Capsules
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2023
FDA Product Classification

INGREDIENTS (10)

TRIAMTERENEActive
Quantity: 100 mg in 1 1
Code: WS821Z52LQ
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT

Triamterene Capsules

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code52817-364
Application NumberANDA211581
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamterene Capsules
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2023
FDA Product Classification

INGREDIENTS (10)

TRIAMTERENEActive
Quantity: 50 mg in 1 1
Code: WS821Z52LQ
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT

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Triamterene - FDA Drug Approval Details