FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
70771-1120
11-digit product format
707711120
Labeler code
70771
Product ID
70771-1120_71694aca-1930-42bc-8322-6470fd047953
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA090961
Marketing category
ANDA
Marketing start
2017-09-28
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
70771-1120-0Memantine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10007
70771-1120-1Memantine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1007
70771-1120-2Memantine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED17
70771-1120-4Memantine Hydrochloride1000 in 1 CARTONTABLET, FILM COATED10007
70771-1120-5Memantine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5007
70771-1120-6Memantine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1120MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]7Current NDC, Legacy NDC, 6 package rows20240821_514421f3-f525-43e8-aecc-8b2bbffd00dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSN514421f3-f525-43e8-aecc-8b2bbffd00dc7
996571memantine HCl 5 MG Oral TabletPSN514421f3-f525-43e8-aecc-8b2bbffd00dc7
996561memantine hydrochloride 10 MG Oral TabletSCD514421f3-f525-43e8-aecc-8b2bbffd00dc7
996571memantine hydrochloride 5 MG Oral TabletSCD514421f3-f525-43e8-aecc-8b2bbffd00dc7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1120-0707711120001000 TABLET, FILM COATED in 1 BOTTLE (70771-1120-0) 2017-09-280000-00-00NoNoCurrent
70771-1120-170771112001100 TABLET, FILM COATED in 1 BOTTLE (70771-1120-1) 2017-09-280000-00-00NoNoCurrent
70771-1120-2707711120021 in 1 BLISTER PACKHistorical
70771-1120-4707711120041000 BLISTER PACK in 1 CARTON (70771-1120-4) / 1 TABLET, FILM COATED in 1 BLISTER PACK (70771-1120-2) 1000 blister pack2017-09-280000-00-00NoNoCurrent
70771-1120-570771112005500 TABLET, FILM COATED in 1 BOTTLE (70771-1120-5) 2017-09-280000-00-00NoNoCurrent
70771-1120-67077111200660 TABLET, FILM COATED in 1 BOTTLE (70771-1120-6) 2017-09-280000-00-00NoNoCurrent