Memantine

Product NDC
0615-8100
11-digit product format
006158100
Labeler code
0615
Product ID
0615-8100_a788d2b2-f529-400d-842e-93b2556b5d80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA090048
Marketing category
ANDA
Marketing start
2015-07-11
Marketing end
2021-07-31
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
0000-00-00
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
0615-8100-05Memantine15 in 1 BLISTER PACKTABLET1511
0615-8100-39Memantine30 in 1 BLISTER PACKTABLET3011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8100MEMANTINE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]11Legacy NDC, 2 package rows20240814_a5dcc0e7-761f-4294-bb48-e5ee4a1e2f67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSNa5dcc0e7-761f-4294-bb48-e5ee4a1e2f6711
996571memantine HCl 5 MG Oral TabletPSNa5dcc0e7-761f-4294-bb48-e5ee4a1e2f6711
996561memantine hydrochloride 10 MG Oral TabletSCDa5dcc0e7-761f-4294-bb48-e5ee4a1e2f6711
996571memantine hydrochloride 5 MG Oral TabletSCDa5dcc0e7-761f-4294-bb48-e5ee4a1e2f6711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8100-050061581000515 TABLET in 1 BLISTER PACK (0615-8100-05) 15 tablet2019-04-162021-07-31NoNoCurrent
0615-8100-390061581003930 TABLET in 1 BLISTER PACK (0615-8100-39) 30 tablet2019-04-162021-07-31NoNoCurrent