FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
50090-4434
11-digit product format
500904434
Labeler code
50090
Product ID
50090-4434_94798fba-7e49-4943-b971-0362b5155219
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
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJY0WD0UA60
Rxcui996561

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
50090-4434-0Memantine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED909
50090-4434-1Memantine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED609
50090-4434-2Memantine Hydrochloride180 in 1 BOTTLETABLET, FILM COATED1809

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4434-0EA - Each50090-4434b5d1688a-0509-46cc-9f06-0fb6b5edb95412022-12-07
50090-4434-1EA - Each50090-443411ab26a8-645f-4e82-bcde-96500b49e77312022-12-07
50090-4434-2EA - Each50090-4434d472627f-479e-419d-afba-4a53c43643c512022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4434MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 3 package rows20240906_ca619439-f4ca-43f1-9261-9aa2b6dc7450.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSNca619439-f4ca-43f1-9261-9aa2b6dc74509
996561memantine hydrochloride 10 MG Oral TabletSCDca619439-f4ca-43f1-9261-9aa2b6dc74509

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4434-05009044340090 TABLET, FILM COATED in 1 BOTTLE (50090-4434-0) 2019-07-220000-00-00NoNoCurrent
50090-4434-15009044340160 TABLET, FILM COATED in 1 BOTTLE (50090-4434-1) 2022-10-200000-00-00NoNoCurrent
50090-4434-250090443402180 TABLET, FILM COATED in 1 BOTTLE (50090-4434-2) 2022-10-200000-00-00NoNoCurrent