FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
63629-7397
11-digit product format
636297397
Labeler code
63629
Product ID
63629-7397_255e52a7-68c2-4f2a-8dc4-46f95d68c568
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200022
Marketing category
ANDA
Marketing start
2015-11-01
Marketing end
0000-00-00
Substance
MEMANTINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7397-12024-01-30C16284748780-11030e365-285e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003
63629-7397-22024-01-30C16284748780-11030e365-285e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003
63629-7397-32024-01-30C16284748780-11030e365-285e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003
63629-7397-42024-01-30C16284748780-11030e365-285e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7397-1Memantine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED305
63629-7397-2Memantine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED605
63629-7397-3Memantine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED905
63629-7397-4Memantine Hydrochloride180 in 1 BOTTLETABLET, FILM COATED1805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7397MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]5Legacy NDC, 4 package rows20220115_255e52a7-68c2-4f2a-8dc4-46f95d68c568.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSN255e52a7-68c2-4f2a-8dc4-46f95d68c5685
996561memantine hydrochloride 10 MG Oral TabletSCD255e52a7-68c2-4f2a-8dc4-46f95d68c5685

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7397-16362973970130 TABLET, FILM COATED in 1 BOTTLE (63629-7397-1) 2017-09-220000-00-00NoNoCurrent
63629-7397-26362973970260 TABLET, FILM COATED in 1 BOTTLE (63629-7397-2) 2020-12-230000-00-00NoNoCurrent
63629-7397-36362973970390 TABLET, FILM COATED in 1 BOTTLE (63629-7397-3) 2021-12-220000-00-00NoNoCurrent
63629-7397-463629739704180 TABLET, FILM COATED in 1 BOTTLE (63629-7397-4) 2021-12-220000-00-00NoNoCurrent