triamterene and hydrochlorothiazide
Triamterene and Hydrochlorothiazide Tablets, USPRx only
Approved
Approval ID
27b8f965-d73f-411c-aae6-bcae6e281113
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 23, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-6736
Application NumberANDA208360
Product Classification
M
Marketing Category
C73584
G
Generic Name
triamterene and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 26, 2023
FDA Product Classification
INGREDIENTS (8)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TRIAMTERENEActive
Quantity: 75 mg in 1 1
Code: WS821Z52LQ
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 50 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT