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
NDC Product Code43353-931
Application NumberANDA076698
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateFebruary 26, 2014
Generic Namemetolazone
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
NDC Product Code43353-890
Application NumberANDA076698
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateFebruary 26, 2014
Generic Namemetolazone
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