Memantine Hydrochloride

Product NDC
67046-1471
11-digit product format
670461471
Labeler code
67046
Product ID
67046-1471_2d54b58a-d1dc-e87f-e063-6394a90ab92e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA090961
Marketing category
ANDA
Marketing start
2025-02-04
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Memantine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEMANTINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJY0WD0UA60
Rxcui996571

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
67046-1471-3Memantine Hydrochloride30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1471MEMANTINE HYDROCHLORIDE TABLET [COUPLER LLC]1Current NDC, 1 package rows20250206_2d54be77-75b2-76b3-e063-6294a90a0cc0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996571memantine HCl 5 MG Oral TabletPSN2d54be77-75b2-76b3-e063-6294a90a0cc01
996571memantine hydrochloride 5 MG Oral TabletSCD2d54be77-75b2-76b3-e063-6294a90a0cc01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1471-36704614710330 TABLET in 1 BLISTER PACK (67046-1471-3) 30 tablet2025-02-04NoNoHistorical