Metolazone
Metolazone Tablets, USP Rx Only
Approved
Approval ID
c67c00c9-2c2c-6223-e053-2995a90a7291
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 15, 2023
Manufacturers
FDA
Golden State Medical Supply, Inc.
DUNS: 603184490
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 Code51407-433
Application NumberANDA213827
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metolazone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2023
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
METOLAZONEActive
Quantity: 10 mg in 1 1
Code: TZ7V40X7VX
Classification: ACTIB
Metolazone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51407-432
Application NumberANDA213827
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metolazone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2023
FDA Product Classification
INGREDIENTS (5)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
METOLAZONEActive
Quantity: 5 mg in 1 1
Code: TZ7V40X7VX
Classification: ACTIB
Metolazone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51407-431
Application NumberANDA213827
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metolazone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2023
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
METOLAZONEActive
Quantity: 2.5 mg in 1 1
Code: TZ7V40X7VX
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT