Triamterene hydrochlorothiazide
Triamterene and Hydrochlorothiazide Tablets, USP
Approved
Approval ID
1061baaf-53f8-4a92-b90f-bcecdf1d183e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-497
Application NumberANDA073281
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamterene and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateJuly 30, 2007
FDA Product Classification
INGREDIENTS (9)
TriamtereneActive
Quantity: 75 mg in 1 1
Code: WS821Z52LQ
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
sodium bicarbonateInactive
Code: 8MDF5V39QO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HydrochlorothiazideActive
Quantity: 50 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
Triamterene and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-496
Application NumberANDA072011
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamterene and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateJuly 30, 2007
FDA Product Classification
INGREDIENTS (10)
HydrochlorothiazideActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TriamtereneActive
Quantity: 37.5 mg in 1 1
Code: WS821Z52LQ
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
sodium bicarbonateInactive
Code: 8MDF5V39QO
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT