FDA.reportPublic FDA data

memantine hydrochloride

Product NDC
50090-7348
11-digit product format
500907348
Labeler code
50090
Product ID
50090-7348_268c8634-c170-4123-a681-5c0ec4ee45c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204389
Marketing category
ANDA
Marketing start
2022-09-26
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
50090-7348-0memantine hydrochloride60 in 1 BOTTLETABLET601
50090-7348-1memantine hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7348-0EA - Each50090-734846658798-62c7-4b58-92bb-f443608e58e912024-11-05
50090-7348-1EA - Each50090-73489cbab948-9663-430b-bb78-81893480e6b712024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7348MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE) TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20241023_4d48c958-b606-4427-8502-53450718eefb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996571memantine HCl 5 MG Oral TabletPSN4d48c958-b606-4427-8502-53450718eefb1
996571memantine hydrochloride 5 MG Oral TabletSCD4d48c958-b606-4427-8502-53450718eefb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7348-05009073480060 TABLET in 1 BOTTLE (50090-7348-0) 60 tablet2024-10-16NoNoCurrent
50090-7348-15009073480190 TABLET in 1 BOTTLE (50090-7348-1) 90 tablet2024-10-16NoNoCurrent