FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
72578-004
11-digit product format
725780004
Labeler code
72578
Product ID
72578-004_2dee57d8-27d7-481c-b1c9-21375e258a1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA090961
Marketing category
ANDA
Marketing start
2019-02-28
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Memantine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEMANTINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJY0WD0UA60
Rxcui996561, 996571

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
72578-004-01Memantine Hydrochloride100 in 1 BOTTLETABLET1003
72578-004-05Memantine Hydrochloride500 in 1 BOTTLETABLET5003
72578-004-10Memantine Hydrochloride1000 in 1 BOTTLETABLET10003
72578-004-14Memantine Hydrochloride60 in 1 BOTTLETABLET603
72578-004-30Memantine Hydrochloride10 in 1 BLISTER PACKTABLET103
72578-004-77Memantine Hydrochloride10 in 1 CARTONTABLET103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-004-05EA - Each72578-004882d8c46-ddff-475c-adff-4b2b9359aa6612019-12-10
72578-004-14EA - Each72578-0045a3cb444-d2b4-4a4f-a511-d6814ba6e95a12019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-004MEMANTINE HYDROCHLORIDE TABLET [VIONA PHARMACEUTICALS INC]3Current NDC, Legacy NDC, 6 package rows20221014_dcbdb62a-a4e2-4058-b73c-46005f2a5d51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSN54a12ddf-306b-4eb7-a7c3-c7b58df3b372102
996561memantine HCl 10 MG Oral TabletPSNc8f96b24-de66-4a17-b798-42b42a25e84c102
996561memantine hydrochloride 10 MG Oral TabletSCD54a12ddf-306b-4eb7-a7c3-c7b58df3b372102
996561memantine hydrochloride 10 MG Oral TabletSCDc8f96b24-de66-4a17-b798-42b42a25e84c102
996561memantine HCl 10 MG Oral TabletPSNbe919d34-e9f4-49c8-8145-2dcafb7cb88c100
996561memantine hydrochloride 10 MG Oral TabletSCDbe919d34-e9f4-49c8-8145-2dcafb7cb88c100
996561memantine HCl 10 MG Oral TabletPSNbf395152-2885-4633-bf3f-2da46e7b79f14
996561memantine hydrochloride 10 MG Oral TabletSCDbf395152-2885-4633-bf3f-2da46e7b79f14
996561memantine HCl 10 MG Oral TabletPSNdcbdb62a-a4e2-4058-b73c-46005f2a5d513
996571memantine HCl 5 MG Oral TabletPSNdcbdb62a-a4e2-4058-b73c-46005f2a5d513
996561memantine hydrochloride 10 MG Oral TabletSCDdcbdb62a-a4e2-4058-b73c-46005f2a5d513
996571memantine hydrochloride 5 MG Oral TabletSCDdcbdb62a-a4e2-4058-b73c-46005f2a5d513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72578-004-0172578000401100 TABLET in 1 BOTTLE (72578-004-01) 100 tablet2019-02-280000-00-00NoNoCurrent
72578-004-0572578000405500 TABLET in 1 BOTTLE (72578-004-05) 500 tablet2019-02-280000-00-00NoNoCurrent
72578-004-10725780004101000 TABLET in 1 BOTTLE (72578-004-10) 1000 tablet2019-02-280000-00-00NoNoCurrent
72578-004-147257800041460 TABLET in 1 BOTTLE (72578-004-14) 60 tablet2019-02-280000-00-00NoNoCurrent
72578-004-307257800043010 in 1 BLISTER PACKHistorical
72578-004-777257800047710 BLISTER PACK in 1 CARTON (72578-004-77) / 10 TABLET in 1 BLISTER PACK (72578-004-30) 10 blister pack2019-02-280000-00-00NoNoCurrent