FDA.reportPublic FDA data

memantine hydrochloride

Product NDC
0591-3900
11-digit product format
005913900
Labeler code
0591
Product ID
0591-3900_985e1190-b8a0-4775-9a20-ad1924b14fb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
KIT
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
NDA021487
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-04-01
Marketing end
2028-08-31
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
memantine hydrochloride

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJY0WD0UA60
Rxcui996561, 996571, 996572

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
0591-3900-87memantine hydrochloride1 in 1 BLISTER PACKKIT110
0591-3900-87memantine hydrochloride1 in 1 CARTONKIT110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3900-87EA - Each0591-3900c1294d08-4c32-4f08-9dc9-afba8d28592c12015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEMANTINE HYDROCHLORIDEACTIVE INGREDIENTJY0WD0UA60MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
memantineACTIVE MOIETYW8O17SJF3TMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
FD&C blue No. 2INACTIVE INGREDIENTL06K8R7DQKMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
sorbitolINACTIVE INGREDIENT506T60A25RMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
talcINACTIVE INGREDIENT7SEV7J4R1UMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3900MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC.]10Current NDC, Legacy NDC, 2 package rows20240509_72973b46-f307-4a9e-8fb1-ad2cbccfd736.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996572{21 (memantine hydrochloride 10 MG Oral Tablet) / 28 (memantine hydrochloride 5 MG Oral Tablet) } PackGPCK72973b46-f307-4a9e-8fb1-ad2cbccfd73610
996561memantine HCl 10 MG Oral TabletPSN72973b46-f307-4a9e-8fb1-ad2cbccfd73610
996572memantine HCl 5 MG (28) / 10 MG (21) Tablet Titration PackPSN72973b46-f307-4a9e-8fb1-ad2cbccfd73610
996571memantine HCl 5 MG Oral TabletPSN72973b46-f307-4a9e-8fb1-ad2cbccfd73610
996561memantine hydrochloride 10 MG Oral TabletSCD72973b46-f307-4a9e-8fb1-ad2cbccfd73610
996571memantine hydrochloride 5 MG Oral TabletSCD72973b46-f307-4a9e-8fb1-ad2cbccfd73610
996572memantine HCl 5 MG (28) / 10 MG (21) Tablet Titration PackSY72973b46-f307-4a9e-8fb1-ad2cbccfd73610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-3900-87005913900871 BLISTER PACK in 1 CARTON (0591-3900-87) / 1 KIT in 1 BLISTER PACK1 blister pack2015-04-012028-08-31NoNoCurrent