FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
71335-1798
11-digit product format
713351798
Labeler code
71335
Product ID
71335-1798_58b20655-c2be-4944-ad89-d2526af0949f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090073
Marketing category
ANDA
Marketing start
2020-06-05
Marketing end
0000-00-00
Substance
MEMANTINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
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
71335-1798-12024-01-30C16284748780-11030e365-24b3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
71335-1798-22024-01-30C16284748780-11030e365-24b3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1798-1Memantine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30100
71335-1798-2Memantine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1798MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]100Legacy NDC, 2 package rows20220106_d77172c4-f84a-4310-907f-7222d330a383.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996571memantine HCl 5 MG Oral TabletPSNd77172c4-f84a-4310-907f-7222d330a383100
996571memantine hydrochloride 5 MG Oral TabletSCDd77172c4-f84a-4310-907f-7222d330a383100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1798-17133517980130 TABLET, FILM COATED in 1 BOTTLE (71335-1798-1) 2021-12-200000-00-00NoNoCurrent
71335-1798-27133517980260 TABLET, FILM COATED in 1 BOTTLE (71335-1798-2) 2021-12-200000-00-00NoNoCurrent