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.

NDC Product Code71610-142

Application NumberNDA017386

Marketing CategoryC73605

Route of AdministrationORAL

Effective DateSeptember 10, 2018

Generic Namemetolazone

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