METOLAZONE
Metolazone Tablets, USP
Approved
Approval ID
51300edb-2b0f-427c-aeed-bc74a12f52ce
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2023
Manufacturers
FDA
Aarkish Pharmaceuticals NJ Inc.
DUNS: 117729250
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 Code81005-126
Application NumberANDA216216
Product Classification
M
Marketing Category
C73584
G
Generic Name
metolazone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2023
FDA Product Classification
INGREDIENTS (5)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METOLAZONEActive
Quantity: 10 mg in 1 1
Code: TZ7V40X7VX
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
metolazone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81005-124
Application NumberANDA216216
Product Classification
M
Marketing Category
C73584
G
Generic Name
metolazone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2023
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
METOLAZONEActive
Quantity: 2.5 mg in 1 1
Code: TZ7V40X7VX
Classification: ACTIB
metolazone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81005-125
Application NumberANDA216216
Product Classification
M
Marketing Category
C73584
G
Generic Name
metolazone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2023
FDA Product Classification
INGREDIENTS (5)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METOLAZONEActive
Quantity: 5 mg in 1 1
Code: TZ7V40X7VX
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT