METOLAZONE
Metolazone Tablets, USP Rx only
Approved
Approval ID
a84dbb37-648e-42d4-8688-ac39599284f0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 26, 2022
Manufacturers
FDA
Alembic Pharmaceuticals Inc.
DUNS: 079288842
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
METOLAZONE
PRODUCT DETAILS
NDC Product Code62332-534
Application NumberANDA213251
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 26, 2022
Generic NameMETOLAZONE
INGREDIENTS (5)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
METOLAZONEActive
Quantity: 10 mg in 1 1
Code: TZ7V40X7VX
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
METOLAZONE
PRODUCT DETAILS
NDC Product Code62332-532
Application NumberANDA213251
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 26, 2022
Generic NameMETOLAZONE
INGREDIENTS (4)
METOLAZONEActive
Quantity: 2.5 mg in 1 1
Code: TZ7V40X7VX
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
METOLAZONE
PRODUCT DETAILS
NDC Product Code62332-533
Application NumberANDA213251
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 26, 2022
Generic NameMETOLAZONE
INGREDIENTS (4)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
METOLAZONEActive
Quantity: 5 mg in 1 1
Code: TZ7V40X7VX
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT