FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
46708-452
11-digit product format
467080452
Labeler code
46708
Product ID
46708-452_3d66d5be-d570-4041-82bf-6b6f4eef9ed8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA200891
Marketing category
ANDA
Marketing start
2015-10-13
Substance
MEMANTINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46708-452-102023-02-01C16284748780-1f386c649-9ba0-0266-e053-dadaa90a7c1aThese Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003
46708-452-202023-02-01C16284748780-1f386c649-9ba0-0266-e053-dadaa90a7c1aThese Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003
46708-452-302023-02-01C16284748780-1f386c649-9ba0-0266-e053-dadaa90a7c1aThese Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003
46708-452-312023-02-01C16284748780-1f386c649-9ba0-0266-e053-dadaa90a7c1aThese Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003
46708-452-422023-02-01C16284748780-1f386c649-9ba0-0266-e053-dadaa90a7c1aThese Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003
46708-452-602023-02-01C16284748780-1f386c649-9ba0-0266-e053-dadaa90a7c1aThese Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003
46708-452-712023-02-01C16284748780-1f386c649-9ba0-0266-e053-dadaa90a7c1aThese Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003
46708-452-102023-01-30C16284748780-1f386c649-9ba0-0266-e053-dadaa90a7c1aThese Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003
46708-452-202023-01-30C16284748780-1f386c649-9ba0-0266-e053-dadaa90a7c1aThese Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003
46708-452-302023-01-30C16284748780-1f386c649-9ba0-0266-e053-dadaa90a7c1aThese Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003
46708-452-312023-01-30C16284748780-1f386c649-9ba0-0266-e053-dadaa90a7c1aThese Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003
46708-452-422023-01-30C16284748780-1f386c649-9ba0-0266-e053-dadaa90a7c1aThese Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003
46708-452-602023-01-30C16284748780-1f386c649-9ba0-0266-e053-dadaa90a7c1aThese Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003
46708-452-712023-01-30C16284748780-1f386c649-9ba0-0266-e053-dadaa90a7c1aThese Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-452-10Memantine Hydrochloride100 in 1 CARTONTABLET, COATED1003
46708-452-20Memantine Hydrochloride20 in 1 BOTTLETABLET, COATED203
46708-452-30Memantine Hydrochloride30 in 1 BOTTLETABLET, COATED303
46708-452-31Memantine Hydrochloride100 in 1 BOTTLETABLET, COATED1003
46708-452-42Memantine Hydrochloride3000 in 1 BOTTLETABLET, COATED30003
46708-452-60Memantine Hydrochloride60 in 1 BOTTLETABLET, COATED603
46708-452-71Memantine Hydrochloride500 in 1 BOTTLETABLET, COATED5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-452MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS LIMITED]3Current NDC, Legacy NDC, 7 package rows20230202_b86c0f6e-480b-40e7-aa4d-21bd0659101d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSNb86c0f6e-480b-40e7-aa4d-21bd0659101d3
996571memantine HCl 5 MG Oral TabletPSNb86c0f6e-480b-40e7-aa4d-21bd0659101d3
996561memantine hydrochloride 10 MG Oral TabletSCDb86c0f6e-480b-40e7-aa4d-21bd0659101d3
996571memantine hydrochloride 5 MG Oral TabletSCDb86c0f6e-480b-40e7-aa4d-21bd0659101d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46708-452-1046708045210100 TABLET, COATED in 1 CARTON (46708-452-10) 2015-10-130000-00-00NoNoCurrent
46708-452-204670804522020 TABLET, COATED in 1 BOTTLE (46708-452-20) 2015-10-130000-00-00NoNoCurrent
46708-452-304670804523030 TABLET, COATED in 1 BOTTLE (46708-452-30) 2015-10-130000-00-00NoNoCurrent
46708-452-3146708045231100 TABLET, COATED in 1 BOTTLE (46708-452-31) 2015-10-130000-00-00NoNoCurrent
46708-452-42467080452423000 TABLET, COATED in 1 BOTTLE (46708-452-42) 2015-10-130000-00-00NoNoCurrent
46708-452-604670804526060 TABLET, COATED in 1 BOTTLE (46708-452-60) 2015-10-130000-00-00NoNoCurrent
46708-452-7146708045271500 TABLET, COATED in 1 BOTTLE (46708-452-71) 2015-10-130000-00-00NoNoCurrent