Namenda

Product NDC
21695-169
11-digit product format
216950169
Labeler code
21695
Product ID
21695-169_74ce605d-b493-4b95-9d59-9253f81f4e20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA021487
Marketing category
NDA
Marketing start
2004-11-17
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
21695-169-302019-09-24C16284748780-1934fe258-4cfe-48b1-e053-8cdaa90a720aNamenda
21695-169-602019-09-24C16284748780-1934fe258-4cfe-48b1-e053-8cdaa90a720aNamenda

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-169-30Namenda30 in 1 BOTTLETABLET301
21695-169-60Namenda60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-169-30EA - Each21695-169a92892f5-dfd1-44a8-ba0a-309ebfd3f89712012-07-24
21695-169-60EA - Each21695-169585c96de-7a3e-4b17-ba52-e9a86a4f740f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
21695-169NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110104_74ce605d-b493-4b95-9d59-9253f81f4e20.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 formatDescriptionStatus
21695-169-302169501693030 in 1 BOTTLEHistorical
21695-169-602169501696060 in 1 BOTTLEHistorical