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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-534
Application NumberANDA213251
Product Classification
M
Marketing Category
C73584
G
Generic Name
METOLAZONE
Product Specifications
Route of AdministrationORAL
Effective DateApril 26, 2022
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-532
Application NumberANDA213251
Product Classification
M
Marketing Category
C73584
G
Generic Name
METOLAZONE
Product Specifications
Route of AdministrationORAL
Effective DateApril 26, 2022
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-533
Application NumberANDA213251
Product Classification
M
Marketing Category
C73584
G
Generic Name
METOLAZONE
Product Specifications
Route of AdministrationORAL
Effective DateApril 26, 2022
FDA Product Classification
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