Metolazone
Metolazone Tablets, USP
Approved
Approval ID
8f8a79d5-5404-46f1-9974-47ae05e855d7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 11, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Metolazone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-8733
Application NumberANDA076466
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metolazone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2023
FDA Product Classification
INGREDIENTS (5)
METOLAZONEActive
Quantity: 5 mg in 1 1
Code: TZ7V40X7VX
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT