Memantine Hydrochloride

Product NDC
50090-5926
11-digit product format
500905926
Labeler code
50090
Product ID
50090-5926_99e7c450-2c83-487e-a326-76c1653723b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA200022
Marketing category
ANDA
Marketing start
2015-11-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Memantine Hydrochloride
Listing expiration
2026-12-31

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
50090-5926-0Memantine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED606
50090-5926-1Memantine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5926MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20231123_2fdf0b2b-0337-472d-83ec-075c17c9b0d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996571memantine HCl 5 MG Oral TabletPSN2fdf0b2b-0337-472d-83ec-075c17c9b0d06
996571memantine hydrochloride 5 MG Oral TabletSCD2fdf0b2b-0337-472d-83ec-075c17c9b0d06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5926-05009059260060 TABLET, FILM COATED in 1 BOTTLE (50090-5926-0) 2022-03-010000-00-00NoNoCurrent
50090-5926-15009059260190 TABLET, FILM COATED in 1 BOTTLE (50090-5926-1) 2022-07-020000-00-00NoNoCurrent