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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0904-6915
Application NumberNDA017386
Product Classification
M
Marketing Category
C73605
G
Generic Name
metolazone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 23, 2022
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0904-6916
Application NumberNDA017386
Product Classification
M
Marketing Category
C73605
G
Generic Name
metolazone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 23, 2022
FDA Product Classification
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