metolazone
Metolazone Tablets, USP
Approved
Approval ID
1276bde6-daf5-44a7-bf92-84d7d24ac3ca
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 23, 2022
Manufacturers
FDA
Major Pharmaceuticals
DUNS: 191427277
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 Code0904-6915
Application NumberNDA017386
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateAugust 23, 2022
Generic Namemetolazone
INGREDIENTS (4)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METOLAZONEActive
Quantity: 5 mg in 1 1
Code: TZ7V40X7VX
Classification: ACTIB
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
metolazone
PRODUCT DETAILS
NDC Product Code0904-6916
Application NumberNDA017386
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateAugust 23, 2022
Generic Namemetolazone
INGREDIENTS (6)
METOLAZONEActive
Quantity: 2.5 mg in 1 1
Code: TZ7V40X7VX
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT