Memantine Hydrochloride

Product NDC
61442-192
11-digit product format
614420192
Labeler code
61442
Product ID
61442-192_3430551c-c9c0-c8ab-e063-6394a90adfba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Carlsbad Technology, Inc.
Application
ANDA212947
Marketing category
ANDA
Marketing start
2025-06-22
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
Rxcui996561, 996571

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
61442-192-05Memantine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5002
61442-192-60Memantine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSN30b4d5c4-0a31-c385-e063-6394a90adbce2
996571memantine HCl 5 MG Oral TabletPSN30b4d5c4-0a31-c385-e063-6394a90adbce2
996561memantine hydrochloride 10 MG Oral TabletSCD30b4d5c4-0a31-c385-e063-6394a90adbce2
996571memantine hydrochloride 5 MG Oral TabletSCD30b4d5c4-0a31-c385-e063-6394a90adbce2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
61442-192-0561442019205500 TABLET, FILM COATED in 1 BOTTLE (61442-192-05) 2025-06-22NoNoCurrent
61442-192-606144201926060 TABLET, FILM COATED in 1 BOTTLE (61442-192-60) 2025-06-22NoNoCurrent