Metolazone
Approved
Approval ID
80500d09-e1c5-450a-9806-f4f13843229d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2017
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 2
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 Code43353-931
Application NumberANDA076698
Product Classification
M
Marketing Category
C73584
G
Generic Name
metolazone
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 26, 2014
FDA Product Classification
INGREDIENTS (5)
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METOLAZONEActive
Quantity: 5 mg in 1 1
Code: TZ7V40X7VX
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
metolazone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-890
Application NumberANDA076698
Product Classification
M
Marketing Category
C73584
G
Generic Name
metolazone
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 26, 2014
FDA Product Classification
INGREDIENTS (5)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
METOLAZONEActive
Quantity: 2.5 mg in 1 1
Code: TZ7V40X7VX
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT