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Memantine Hydrochloride

These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE solution safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE solution. MEMANTINE HYDROCHLORIDE solution, for oral use Initial U.S. Approval: 2003

Approved
Approval ID

42f0a9f2-4aa4-46fb-bc24-d3df843bb906

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 17, 2022

Manufacturers
FDA

Macleods Pharmaceuticals Limited

DUNS: 862128535

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 Code33342-066
Application NumberANDA202790
Product Classification
M
Marketing Category
C73584
G
Generic Name
Memantine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 17, 2022
FDA Product Classification

INGREDIENTS (10)

SORBITOLInactive
Code: 506T60A25R
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
MEMANTINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: JY0WD0UA60
Classification: ACTIB

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Memantine Hydrochloride - FDA Drug Approval Details