Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide Tablets USP Rx only
Approved
Approval ID
ab32b7f6-0a2b-426d-b399-358ba1347cc8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
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 Code53808-0804
Application NumberANDA071851
Product Classification
M
Marketing Category
C73584
G
Generic Name
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Product Specifications
Route of AdministrationORAL
Effective DateJune 7, 2010
FDA Product Classification
INGREDIENTS (8)
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
HYDROCHLOROTHIAZIDEActive
Quantity: 50 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
TRIAMTERENEActive
Quantity: 75 mg in 1 1
Code: WS821Z52LQ
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT