Memantine

Product NDC
72603-118
11-digit product format
726030118
Labeler code
72603
Product ID
72603-118_dd10c9a1-a7af-b51f-4317-ee2290f19a85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA090048
Marketing category
ANDA
Marketing start
2022-09-13
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
Listing expiration
2026-12-31

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
5b597f00-4538-4686-aa4e-3c60ed3788c8Product name220210511
1836e79a-a4d1-4087-2f2e-f878e8a1fef2Product name920151209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-118-01Memantine60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-118MEMANTINE TABLET [NORTHSTAR RXLLC]2Current NDC, Legacy NDC, 1 package rows20231227_7a40ed9d-8853-b616-ff47-0c7b0fd28959.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSN7a40ed9d-8853-b616-ff47-0c7b0fd289592
996571memantine HCl 5 MG Oral TabletPSN7a40ed9d-8853-b616-ff47-0c7b0fd289592
996561memantine hydrochloride 10 MG Oral TabletSCD7a40ed9d-8853-b616-ff47-0c7b0fd289592
996571memantine hydrochloride 5 MG Oral TabletSCD7a40ed9d-8853-b616-ff47-0c7b0fd289592

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72603-118-017260301180160 TABLET in 1 BOTTLE (72603-118-01) 60 tablet2022-09-130000-00-00NoNoCurrent