Triamterene hydrochlorothiazide
Triamterene and Hydrochlorothiazide Tablets, USP
Approved
Approval ID
d72b6798-ae72-4372-aa46-b41c66e231df
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 3, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-2679
Application NumberANDA073281
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamterene and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 3, 2012
FDA Product Classification
INGREDIENTS (10)
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TRIAMTERENEActive
Quantity: 37.5 mg in 1 1
Code: WS821Z52LQ
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Triamterene and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-1866
Application NumberANDA072011
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamterene and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 3, 2012
FDA Product Classification
INGREDIENTS (9)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TRIAMTERENEActive
Quantity: 75 mg in 1 1
Code: WS821Z52LQ
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 50 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT