Memantine Hydrochloride

Product NDC
70518-3338
11-digit product format
705183338
Labeler code
70518
Product ID
70518-3338_4ef2fe7f-4ec2-9825-e063-6394a90ae817
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090961
Marketing category
ANDA
Marketing start
2022-01-20
Substance
MEMANTINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Memantine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEMANTINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJY0WD0UA60
Rxcui996571

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94db636e-a074-45fd-8e8d-331920a99436Product name420250103
941773f8-a40e-0684-da08-ff9a143e6368Product name720231219
5b597f00-4538-4686-aa4e-3c60ed3788c8Product name220210511
1836e79a-a4d1-4087-2f2e-f878e8a1fef2Product name920151209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3338-0Memantine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET307
70518-3338-1Memantine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET607
70518-3338-2Memantine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET907

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996571memantine HCl 5 MG Oral TabletPSNcbfd9d95-f50b-45ff-9857-9f1712c45e567
996571memantine hydrochloride 5 MG Oral TabletSCDcbfd9d95-f50b-45ff-9857-9f1712c45e567

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3338-07051833380030 TABLET in 1 BOTTLE, PLASTIC (70518-3338-0) 30 tablet2022-01-200000-00-00NoNoCurrent
70518-3338-17051833380160 in 1 BOTTLE, PLASTICHistorical
70518-3338-27051833380290 TABLET in 1 BOTTLE, PLASTIC (70518-3338-2) 90 tablet2025-05-28NoNoHistorical