FDA.reportPublic FDA data

Namenda

Product NDC
0456-3205
11-digit product format
004563205
Labeler code
0456
Product ID
0456-3205_d2d531d0-0380-4b22-90e8-ca93627b7900
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Allergan, Inc.
Application
NDA021487
Marketing category
NDA
Marketing start
2003-10-16
Marketing end
0000-00-00
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
2023-12-31
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0456-3205-11EA - Each0456-32056e72b62b-568b-4feb-8871-c704eedd2c8812013-02-13
0456-3205-60EA - Each0456-320529f0a396-ef25-47cb-a7b5-f6e7be5dc2a912012-07-24
0456-3205-63EA - Each0456-32054a7bb2c2-6b85-43d1-9867-e474f09fc68312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEMANTINE HYDROCHLORIDEACTIVE INGREDIENTJY0WD0UA60NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
memantineACTIVE MOIETYW8O17SJF3TNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
FD&C blue No. 2INACTIVE INGREDIENTL06K8R7DQKNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
glycerinINACTIVE INGREDIENTPDC6A3C0OXNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
hypromellosesINACTIVE INGREDIENT3NXW29V3WONAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
magnesium stearateINACTIVE INGREDIENT70097M6I30NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
propylene glycolINACTIVE INGREDIENT6DC9Q167V3NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
sorbitolINACTIVE INGREDIENT506T60A25RNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
talcINACTIVE INGREDIENT7SEV7J4R1UNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
MEMANTINE HYDROCHLORIDEACTIVE INGREDIENTJY0WD0UA60NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
MEMANTINEACTIVE MOIETYW8O17SJF3TNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0456-3205NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [ALLERGAN, INC.]19Legacy NDC20241220_b9f27baf-aa2a-443a-9ef5-e002d23407ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSN74ce605d-b493-4b95-9d59-9253f81f4e201
996571memantine HCl 5 MG Oral TabletPSN74ce605d-b493-4b95-9d59-9253f81f4e201
996563Namenda 10 MG Oral TabletPSN74ce605d-b493-4b95-9d59-9253f81f4e201
996574Namenda 5 MG Oral TabletPSN74ce605d-b493-4b95-9d59-9253f81f4e201
996563memantine hydrochloride 10 MG Oral Tablet [Namenda]SBD74ce605d-b493-4b95-9d59-9253f81f4e201
996574memantine hydrochloride 5 MG Oral Tablet [Namenda]SBD74ce605d-b493-4b95-9d59-9253f81f4e201
996561memantine hydrochloride 10 MG Oral TabletSCD74ce605d-b493-4b95-9d59-9253f81f4e201
996571memantine hydrochloride 5 MG Oral TabletSCD74ce605d-b493-4b95-9d59-9253f81f4e201
996563Namenda 10 MG Oral TabletSY74ce605d-b493-4b95-9d59-9253f81f4e201
996574Namenda 5 MG Oral TabletSY74ce605d-b493-4b95-9d59-9253f81f4e201

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0456-3205-600045632056060 TABLET in 1 BOTTLE (0456-3205-60) 60 tablet2003-10-160000-00-00NoNoCurrent
0456-3205-630045632056310 BLISTER PACK in 1 BOX, UNIT-DOSE (0456-3205-63) > 10 TABLET in 1 BLISTER PACK (0456-3205-11) 10 blister pack2003-10-160000-00-00NoNoCurrent