Metolazone
Metolazone Tablets, USP Rx Only
Approved
Approval ID
cbfa3d5c-cce9-4afa-b064-06f1e1041eac
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2023
Manufacturers
FDA
Amici Pharmaceuticals LLC.
DUNS: 079536824
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 Code69292-564
Application NumberANDA213827
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metolazone
Product Specifications
Route of AdministrationORAL
Effective DateMay 4, 2021
FDA Product Classification
INGREDIENTS (5)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METOLAZONEActive
Quantity: 5 mg in 1 1
Code: TZ7V40X7VX
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
Metolazone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69292-562
Application NumberANDA213827
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metolazone
Product Specifications
Route of AdministrationORAL
Effective DateMay 4, 2021
FDA Product Classification
INGREDIENTS (6)
METOLAZONEActive
Quantity: 2.5 mg in 1 1
Code: TZ7V40X7VX
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Metolazone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69292-566
Application NumberANDA213827
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metolazone
Product Specifications
Route of AdministrationORAL
Effective DateMay 4, 2021
FDA Product Classification
INGREDIENTS (6)
METOLAZONEActive
Quantity: 10 mg in 1 1
Code: TZ7V40X7VX
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT