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Metolazone

Approved
Approval ID

e535c22d-ffe7-4adc-b188-9efe4cb580a9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 26, 2017

Manufacturers
FDA

Carilion Materials Management

DUNS: 079239644

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 Code68151-2939
Application NumberANDA076698
Product Classification
M
Marketing Category
C73584
G
Generic Name
metolazone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2004
FDA Product Classification

INGREDIENTS (7)

METOLAZONEActive
Quantity: 10 mg in 1 1
Code: TZ7V40X7VX
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT

metolazone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68151-2942
Application NumberANDA076698
Product Classification
M
Marketing Category
C73584
G
Generic Name
metolazone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2004
FDA Product Classification

INGREDIENTS (5)

METOLAZONEActive
Quantity: 5 mg in 1 1
Code: TZ7V40X7VX
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT

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Metolazone - FDA Drug Approval Details