FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
62980-122
11-digit product format
629800122
Labeler code
62980
Product ID
62980-122_b2acbf19-563c-4995-8ef5-0cee182f2cdf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Vivimed Labs Limited
Application
ANDA090073
Marketing category
ANDA
Marketing start
2015-09-04
Marketing end
0000-00-00
Substance
MEMANTINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62980-122-012020-01-31C16284748780-19d75b9cf-f64a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
62980-122-022020-01-31C16284748780-19d75b9cf-f64a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
62980-122-032020-01-31C16284748780-19d75b9cf-f64a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
62980-122-062020-01-31C16284748780-19d75b9cf-f64a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
62980-122-082020-01-31C16284748780-19d75b9cf-f64a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62980-122-01Memantine Hydrochloride30 in 1 BOTTLETABLET301
62980-122-02Memantine Hydrochloride500 in 1 BOTTLETABLET5001
62980-122-03Memantine Hydrochloride60 in 1 BOTTLETABLET601
62980-122-06Memantine Hydrochloride12 in 1 CARTONTABLET121
62980-122-07Memantine Hydrochloride24 in 1 BLISTER PACKTABLET241
62980-122-08Memantine Hydrochloride100 in 1 BOTTLETABLET1001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEMANTINE HYDROCHLORIDEACTIVE INGREDIENTJY0WD0UA60MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]1
MEMANTINEACTIVE MOIETYW8O17SJF3TMEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]1
TRIACETININACTIVE INGREDIENTXHX3C3X673MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62980-122MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]1Legacy NDC, 6 package rows20151013_4c5bef01-2e31-4181-a040-bb5a2fec949d.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) } PackGPCK4c5bef01-2e31-4181-a040-bb5a2fec949d1
996561memantine HCl 10 MG Oral TabletPSN4c5bef01-2e31-4181-a040-bb5a2fec949d1
996572memantine HCl 5 MG (28) / 10 MG (21) Tablet Titration PackPSN4c5bef01-2e31-4181-a040-bb5a2fec949d1
996571memantine HCl 5 MG Oral TabletPSN4c5bef01-2e31-4181-a040-bb5a2fec949d1
996561memantine hydrochloride 10 MG Oral TabletSCD4c5bef01-2e31-4181-a040-bb5a2fec949d1
996571memantine hydrochloride 5 MG Oral TabletSCD4c5bef01-2e31-4181-a040-bb5a2fec949d1
996572memantine HCl 5 MG (28) / 10 MG (21) Tablet Titration PackSY4c5bef01-2e31-4181-a040-bb5a2fec949d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
62980-122-016298001220130 in 1 BOTTLEHistorical
62980-122-0262980012202500 in 1 BOTTLEHistorical
62980-122-036298001220360 in 1 BOTTLEHistorical
62980-122-066298001220612 in 1 CARTONHistorical
62980-122-076298001220724 in 1 BLISTER PACKHistorical
62980-122-0862980012208100 in 1 BOTTLEHistorical