FDA.reportPublic FDA data

MEMANTINE HYDROCHLORIDE

Product NDC
72189-294
11-digit product format
721890294
Labeler code
72189
Product ID
72189-294_4c5d26cb-a6bf-015e-e063-6294a90aa662
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MEMANTINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
DirectRx
Application
ANDA090961
Marketing category
ANDA
Marketing start
2021-11-11
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
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
72189-294-30MEMANTINE HYDROCHLORIDE30 in 1 BOTTLETABLET304
72189-294-60MEMANTINE HYDROCHLORIDE60 in 1 BOTTLETABLET604
72189-294-90MEMANTINE HYDROCHLORIDE90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-294MEMANTINE HYDROCHLORIDE TABLET [DIRECTRX]2Current NDC, Legacy NDC, 3 package rows20250121_d0839a2d-35f1-1f14-e053-2995a90ad549.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996571memantine HCl 5 MG Oral TabletPSNd0839a2d-35f1-1f14-e053-2995a90ad5494
996571memantine hydrochloride 5 MG Oral TabletSCDd0839a2d-35f1-1f14-e053-2995a90ad5494

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-294-307218902943030 TABLET in 1 BOTTLE (72189-294-30) 30 tablet2021-11-110000-00-00NoNoCurrent
72189-294-607218902946060 TABLET in 1 BOTTLE (72189-294-60) 60 tablet2021-11-11NoNoCurrent
72189-294-907218902949090 TABLET in 1 BOTTLE (72189-294-90) 90 tablet2021-11-110000-00-00NoNoCurrent