Memantine Hydrochloride

Product NDC
0832-1112
11-digit product format
008321112
Labeler code
0832
Product ID
0832-1112_45af280b-1724-c805-e063-6294a90a76ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA090043
Marketing category
ANDA
Marketing start
2015-07-31
Marketing end
2028-01-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Memantine Hydrochloride

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
0832-1112-60Memantine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-1112MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, LLC]8Current NDC, Legacy NDC, 1 package rows20230324_6e0ade9e-b721-4701-bcb7-de464e19e707.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSN6e0ade9e-b721-4701-bcb7-de464e19e70710
996571memantine HCl 5 MG Oral TabletPSN6e0ade9e-b721-4701-bcb7-de464e19e70710
996561memantine hydrochloride 10 MG Oral TabletSCD6e0ade9e-b721-4701-bcb7-de464e19e70710
996571memantine hydrochloride 5 MG Oral TabletSCD6e0ade9e-b721-4701-bcb7-de464e19e70710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0832-1112-600083211126060 TABLET, FILM COATED in 1 BOTTLE (0832-1112-60) 2015-07-312028-01-31NoNoCurrent