FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
50090-6400
11-digit product format
500906400
Labeler code
50090
Product ID
50090-6400_0f1a6f0c-50ec-4e4b-a804-5385a2fd2e40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA206528
Marketing category
ANDA
Marketing start
2015-08-27
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
50090-6400-0Memantine Hydrochloride90 in 1 BOTTLETABLET901
50090-6400-1Memantine Hydrochloride60 in 1 BOTTLETABLET601
50090-6400-2Memantine Hydrochloride180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6400-0EA - Each50090-64009ee75cb8-90e6-466f-83f2-d7ecc008fdee12023-06-06
50090-6400-1EA - Each50090-640081137191-822a-44ec-9754-6b56e3558c3212023-06-06
50090-6400-2EA - Each50090-64007f865062-be7a-4fad-8a7b-d93fc99105df12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6400MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE ) TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20230421_d1c2ec99-7183-46e3-a96e-4f23e20b8b06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSNd1c2ec99-7183-46e3-a96e-4f23e20b8b061
996561memantine hydrochloride 10 MG Oral TabletSCDd1c2ec99-7183-46e3-a96e-4f23e20b8b061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6400-05009064000090 TABLET in 1 BOTTLE (50090-6400-0) 90 tablet2023-03-16NoNoCurrent
50090-6400-15009064000160 TABLET in 1 BOTTLE (50090-6400-1) 60 tablet2023-03-16NoNoCurrent
50090-6400-250090640002180 TABLET in 1 BOTTLE (50090-6400-2) 180 tablet2023-03-16NoNoCurrent