Metolazone
Metolazone Tablets, USP Rx Only
Approved
Approval ID
c9e51766-8f1d-4258-9f40-1d394e2de04c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 13, 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.
Metolazone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-6802
Application NumberANDA213827
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metolazone
Product Specifications
Route of AdministrationORAL
Effective DateMay 4, 2021
FDA Product Classification
INGREDIENTS (6)
METOLAZONEActive
Quantity: 2.5 mg in 1 1
Code: TZ7V40X7VX
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT