memantine hydrochloride
These highlights do not include all the information needed to use Memantine HCl safely and effectively. See full prescribing information for Memantine HCl. Memantine HCl tablets, for oral useMemantine HCl solution, for oral use Initial U.S. Approval: 2003
Approved
Approval ID
c8f5c20b-4573-44c5-89fc-4da11b2e1fe1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2017
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.
memantine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71610-011
Application NumberNDA021487
Product Classification
M
Marketing Category
C73594
G
Generic Name
memantine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2017
FDA Product Classification
INGREDIENTS (5)
MEMANTINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: JY0WD0UA60
Classification: ACTIB
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
polyethylene glycol 400Inactive
Code: B697894SGQ
Classification: IACT
ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT