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Memantine Hydrochloride

These highlights do not include all the information needed to use Memantine Hydrochloride Oral Solution safely and effectively. See full prescribing information for Memantine Hydrochloride Oral Solution.Memantine Hydrochloride Oral Solution, for oral use.  Initial U.S. Approval: 2003

Approved
Approval ID

421f6478-09df-49d3-a7c4-52814b4aa90e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 30, 2024

Manufacturers
FDA

Seton Pharmaceuticals

DUNS: 828898002

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Memantine Hydrochloride Oral

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code13925-540
Application NumberANDA210319
Product Classification
M
Marketing Category
C73584
G
Generic Name
Memantine Hydrochloride Oral
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2021
FDA Product Classification

INGREDIENTS (10)

SORBITOL SOLUTION 70%Inactive
Code: 8KW3E207O2
Classification: IACT
MEMANTINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: JY0WD0UA60
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Memantine Hydrochloride - FDA Drug Approval Details