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