FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
50090-6291
11-digit product format
500906291
Labeler code
50090
Product ID
50090-6291_eb840a53-9a53-42d8-b4ac-c02fd35d3bc7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090961
Marketing category
ANDA
Marketing start
2019-02-28
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
50090-6291-0Memantine Hydrochloride60 in 1 BOTTLETABLET606
50090-6291-1Memantine Hydrochloride90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6291-0EA - Each50090-6291f1a2cc7b-7959-465f-bc08-d1c99b62e09512023-05-05
50090-6291-1EA - Each50090-62912864fec7-51b3-4427-8e17-b56b9c354bd712023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6291MEMANTINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20240531_f05e381f-850d-42ea-9dd8-6d1f8dac4f62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996571memantine HCl 5 MG Oral TabletPSNf05e381f-850d-42ea-9dd8-6d1f8dac4f626
996571memantine hydrochloride 5 MG Oral TabletSCDf05e381f-850d-42ea-9dd8-6d1f8dac4f626

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6291-05009062910060 TABLET in 1 BOTTLE (50090-6291-0) 60 tablet2022-12-210000-00-00NoNoCurrent
50090-6291-15009062910190 TABLET in 1 BOTTLE (50090-6291-1) 90 tablet2022-12-21NoNoCurrent