FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
43353-170
11-digit product format
433530170
Labeler code
43353
Product ID
43353-170_d8a379ae-6534-4ff3-9432-ae292b8b2472
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090043
Marketing category
ANDA
Marketing start
2015-07-31
Marketing end
0000-00-00
Substance
MEMANTINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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
43353-170-182023-01-30C16284748780-1f386c649-e8a1-0266-e053-dadaa90a7c1aThese 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
43353-170-18Memantine Hydrochloride3000 in 1 BOTTLETABLET, FILM COATED30004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-170-18EA - Each43353-170d6d2cf7c-00b4-4b8a-b2e5-b404976931c212016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-170MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Legacy NDC, 1 package rows20191219_ab78bc21-87e3-4ce9-ba41-ac337ffae606.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSNab78bc21-87e3-4ce9-ba41-ac337ffae6064
996561memantine hydrochloride 10 MG Oral TabletSCDab78bc21-87e3-4ce9-ba41-ac337ffae6064

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-170-18433530170183000 TABLET, FILM COATED in 1 BOTTLE (43353-170-18) 2016-04-150000-00-00NoNoCurrent