FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
50268-587
11-digit product format
502680587
Labeler code
50268
Product ID
50268-587_47e7cea9-cd6c-40d4-e063-6294a90a9e8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA200022
Marketing category
ANDA
Marketing start
2024-02-20
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Memantine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEMANTINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJY0WD0UA60
Rxcui996561, 996571

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94db636e-a074-45fd-8e8d-331920a99436Product name420250103
941773f8-a40e-0684-da08-ff9a143e6368Product name720231219
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
5b597f00-4538-4686-aa4e-3c60ed3788c8Product name220210511
1836e79a-a4d1-4087-2f2e-f878e8a1fef2Product name920151209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-587-11Memantine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED12
50268-587-13Memantine Hydrochloride30 in 1 BOXTABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-587-11EA - Each50268-5876a4a9dea-6c96-4103-b098-d44557dd70bb12024-04-05
50268-587-13EA - Each50268-587683940de-4acb-4fa3-9559-3ed7e1077ffc12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-587MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1Current NDC, 2 package rows20240307_11d27c75-fdc0-f9da-e063-6394a90ac6b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSN11d27c75-fdc0-f9da-e063-6394a90ac6b02
996571memantine HCl 5 MG Oral TabletPSN11d27c75-fdc0-f9da-e063-6394a90ac6b02
996561memantine hydrochloride 10 MG Oral TabletSCD11d27c75-fdc0-f9da-e063-6394a90ac6b02
996571memantine hydrochloride 5 MG Oral TabletSCD11d27c75-fdc0-f9da-e063-6394a90ac6b02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50268-587-11502680587111 in 1 BLISTER PACKHistorical
50268-587-135026805871330 BLISTER PACK in 1 BOX (50268-587-13) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-587-11) 30 blister pack2024-02-20NoNoCurrent