FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
71335-1863
11-digit product format
713351863
Labeler code
71335
Product ID
71335-1863_9dddccbd-8e8d-4128-99f4-a31193b44a18
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
10 mg/1
Pharmacologic classes
NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1863-1Memantine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30100
71335-1863-2Memantine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60100
71335-1863-3Memantine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90100
71335-1863-4Memantine Hydrochloride180 in 1 BOTTLETABLET, FILM COATED180100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1863MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]100Legacy NDC, 4 package rows20211023_6ba63a8d-4cbe-45b8-b6cf-675557a8f6e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSN6ba63a8d-4cbe-45b8-b6cf-675557a8f6e0100
996561memantine hydrochloride 10 MG Oral TabletSCD6ba63a8d-4cbe-45b8-b6cf-675557a8f6e0100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1863-17133518630130 TABLET, FILM COATED in 1 BOTTLE (71335-1863-1) 2021-10-210000-00-00NoNoCurrent
71335-1863-27133518630260 TABLET, FILM COATED in 1 BOTTLE (71335-1863-2) 2021-10-210000-00-00NoNoCurrent
71335-1863-37133518630390 TABLET, FILM COATED in 1 BOTTLE (71335-1863-3) 2021-10-210000-00-00NoNoCurrent
71335-1863-471335186304180 TABLET, FILM COATED in 1 BOTTLE (71335-1863-4) 2021-10-210000-00-00NoNoCurrent