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metolazone

Metolazone Tablets, USP

Approved
Approval ID

fae89daa-9103-45d8-9966-cd998f258625

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 12, 2018

Manufacturers
FDA

Aphena Pharma Solutions - Tennessee, LLC

DUNS: 128385585

Products 1

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 Code71610-142
Application NumberNDA017386
Product Classification
M
Marketing Category
C73605
G
Generic Name
metolazone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 10, 2018
FDA Product Classification

INGREDIENTS (4)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METOLAZONEActive
Quantity: 2.5 mg in 1 1
Code: TZ7V40X7VX
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT

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metolazone - FDA Drug Approval Details