FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
50090-5832
11-digit product format
500905832
Labeler code
50090
Product ID
50090-5832_fdbbca96-290b-4c82-b8ca-3f27106a5921
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202840
Marketing category
ANDA
Marketing start
2015-10-13
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
50090-5832-0Memantine Hydrochloride90 in 1 BOTTLETABLET905
50090-5832-1Memantine Hydrochloride60 in 1 BOTTLETABLET605
50090-5832-2Memantine Hydrochloride180 in 1 BOTTLETABLET1805

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5832-0EA - Each50090-5832faee8f23-5404-4937-9351-4f637093038912022-07-06
50090-5832-1EA - Each50090-5832db3dae4d-6b8b-4bb6-b529-51d4f5d574b712022-04-06
50090-5832-2EA - Each50090-5832a28290dd-7d11-4f82-b331-c0dd634c086312022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5832MEMANTINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 3 package rows20231125_66db6d61-cf1d-46ca-a645-19e9a20f4617.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSN66db6d61-cf1d-46ca-a645-19e9a20f46175
996561memantine hydrochloride 10 MG Oral TabletSCD66db6d61-cf1d-46ca-a645-19e9a20f46175

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5832-05009058320090 TABLET in 1 BOTTLE (50090-5832-0) 90 tablet2021-10-270000-00-00NoNoCurrent
50090-5832-15009058320160 TABLET in 1 BOTTLE (50090-5832-1) 60 tablet2022-03-010000-00-00NoNoCurrent
50090-5832-250090583202180 TABLET in 1 BOTTLE (50090-5832-2) 180 tablet2022-03-010000-00-00NoNoCurrent