FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
62332-075
11-digit product format
623320075
Labeler code
62332
Product ID
62332-075_9792a0a6-a48e-4998-9f5a-c9eaa144edea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA200891
Marketing category
ANDA
Marketing start
2015-10-13
Substance
MEMANTINE HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 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
62332-075-10Memantine Hydrochloride100 in 1 CARTONTABLET, COATED10013
62332-075-20Memantine Hydrochloride20 in 1 BOTTLETABLET, COATED2013
62332-075-30Memantine Hydrochloride30 in 1 BOTTLETABLET, COATED3013
62332-075-31Memantine Hydrochloride100 in 1 BOTTLETABLET, COATED10013
62332-075-42Memantine Hydrochloride3000 in 1 BOTTLETABLET, COATED300013
62332-075-60Memantine Hydrochloride60 in 1 BOTTLETABLET, COATED6013
62332-075-91Memantine Hydrochloride1000 in 1 BOTTLETABLET, COATED100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-075-31EA - Each62332-07552faf842-cdfb-4df3-956b-0c7a51e7d91312017-03-06
62332-075-60EA - Each62332-075920fcb7a-3d38-4c30-9bae-32e7acf6de9612015-11-12
62332-075-91EA - Each62332-0753837960b-8baa-4559-a1ef-b9dff588f11412016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEMANTINE HYDROCHLORIDEACTIVE INGREDIENTJY0WD0UA60MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
MEMANTINEACTIVE MOIETYW8O17SJF3TMEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UMEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-075MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]13Current NDC, Legacy NDC, 7 package rows20211012_af2b73da-1be4-4b7f-929b-acb3b9a10f78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSNaf2b73da-1be4-4b7f-929b-acb3b9a10f7813
996571memantine HCl 5 MG Oral TabletPSNaf2b73da-1be4-4b7f-929b-acb3b9a10f7813
996561memantine hydrochloride 10 MG Oral TabletSCDaf2b73da-1be4-4b7f-929b-acb3b9a10f7813
996571memantine hydrochloride 5 MG Oral TabletSCDaf2b73da-1be4-4b7f-929b-acb3b9a10f7813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-075-1062332007510100 TABLET, COATED in 1 CARTON (62332-075-10) 2015-10-130000-00-00NoNoCurrent
62332-075-206233200752020 TABLET, COATED in 1 BOTTLE (62332-075-20) 2015-10-130000-00-00NoNoCurrent
62332-075-306233200753030 TABLET, COATED in 1 BOTTLE (62332-075-30) 2015-10-130000-00-00NoNoCurrent
62332-075-3162332007531100 TABLET, COATED in 1 BOTTLE (62332-075-31) 2015-10-130000-00-00NoNoCurrent
62332-075-42623320075423000 TABLET, COATED in 1 BOTTLE (62332-075-42) 2015-10-130000-00-00NoNoCurrent
62332-075-606233200756060 TABLET, COATED in 1 BOTTLE (62332-075-60) 2015-10-130000-00-00NoNoCurrent
62332-075-91623320075911000 TABLET, COATED in 1 BOTTLE (62332-075-91) 2015-10-130000-00-00NoNoCurrent