Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide Capsules, USP Rx only
Approved
Approval ID
08f3885e-dfde-79e4-e063-6394a90a4c09
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 24, 2023
Manufacturers
FDA
Northwind Pharmaceuticals, LLC
DUNS: 036986393
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 Code82868-022
Application NumberANDA208358
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamterene and Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 24, 2023
FDA Product Classification
INGREDIENTS (16)
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
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
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT