FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
55111-597
11-digit product format
551110597
Labeler code
55111
Product ID
55111-597_998c5d15-8b47-fe20-82c5-98897caf80eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddys Laboratories Limited
Application
ANDA090048
Marketing category
ANDA
Marketing start
2015-07-11
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
55111-597-01Memantine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1006
55111-597-05Memantine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5006
55111-597-30Memantine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED306
55111-597-60Memantine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED606
55111-597-78Memantine Hydrochloride10 in 1 CARTONTABLET, FILM COATED106
55111-597-78Memantine Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED106
55111-597-79Memantine Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED106
55111-597-79Memantine Hydrochloride1 in 1 CARTONTABLET, FILM COATED16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-597MEMANTINE TABLET [DR. REDDYS LABORATORIES LIMITED]5Current NDC, Legacy NDC, 8 package rows20190209_a71e2482-5266-d03e-8b36-862afe78c9a4.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
996561memantine HCl 10 MG Oral TabletPSNd0a5e0fc-04e3-417d-bef3-9b309ff715978
996571memantine HCl 5 MG Oral TabletPSNd0a5e0fc-04e3-417d-bef3-9b309ff715978
996561memantine hydrochloride 10 MG Oral TabletSCDd0a5e0fc-04e3-417d-bef3-9b309ff715978
996571memantine hydrochloride 5 MG Oral TabletSCDd0a5e0fc-04e3-417d-bef3-9b309ff715978
996561memantine HCl 10 MG Oral TabletPSN304a3059-4f7f-4ec4-839d-86492bb5e07b7
996571memantine HCl 5 MG Oral TabletPSN304a3059-4f7f-4ec4-839d-86492bb5e07b7
996561memantine hydrochloride 10 MG Oral TabletSCD304a3059-4f7f-4ec4-839d-86492bb5e07b7
996571memantine hydrochloride 5 MG Oral TabletSCD304a3059-4f7f-4ec4-839d-86492bb5e07b7
996561memantine HCl 10 MG Oral TabletPSNa71e2482-5266-d03e-8b36-862afe78c9a46
996571memantine HCl 5 MG Oral TabletPSNa71e2482-5266-d03e-8b36-862afe78c9a46
996561memantine hydrochloride 10 MG Oral TabletSCDa71e2482-5266-d03e-8b36-862afe78c9a46
996571memantine hydrochloride 5 MG Oral TabletSCDa71e2482-5266-d03e-8b36-862afe78c9a46
996561memantine HCl 10 MG Oral TabletPSN5c8a168d-aef5-4ac7-b8c1-3812a8c228ab3
996561memantine hydrochloride 10 MG Oral TabletSCD5c8a168d-aef5-4ac7-b8c1-3812a8c228ab3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-597-0155111059701100 TABLET, FILM COATED in 1 BOTTLE (55111-597-01) 2015-07-110000-00-00NoNoCurrent
55111-597-0555111059705500 TABLET, FILM COATED in 1 BOTTLE (55111-597-05) 2015-07-110000-00-00NoNoCurrent
55111-597-305511105973030 TABLET, FILM COATED in 1 BOTTLE (55111-597-30) 2015-07-110000-00-00NoNoCurrent
55111-597-605511105976060 TABLET, FILM COATED in 1 BOTTLE (55111-597-60) 2015-07-110000-00-00NoNoCurrent
55111-597-785511105977810 BLISTER PACK in 1 CARTON (55111-597-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2015-07-110000-00-00NoNoCurrent
55111-597-79551110597791 BLISTER PACK in 1 CARTON (55111-597-79) / 10 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2015-07-110000-00-00NoNoCurrent