FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
27241-070
11-digit product format
272410070
Labeler code
27241
Product ID
27241-070_078be4f6-c883-4178-be61-834fb9d5e4f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA206528
Marketing category
ANDA
Marketing start
2015-08-27
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
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
27241-070-05Memantine Hydrochloride500 in 1 BOTTLETABLET5009
27241-070-06Memantine Hydrochloride60 in 1 BOTTLETABLET609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-070-06EA - Each27241-0702e4617c0-4f21-4eef-bdb2-6405e7d9830112016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-070MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE ) TABLET [AJANTA PHARMA USA INC.]8Current NDC, Legacy NDC, 2 package rows20211228_292671f2-f221-4a3d-a110-a266a9527e04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSN292671f2-f221-4a3d-a110-a266a9527e049
996571memantine HCl 5 MG Oral TabletPSN292671f2-f221-4a3d-a110-a266a9527e049
996561memantine hydrochloride 10 MG Oral TabletSCD292671f2-f221-4a3d-a110-a266a9527e049
996571memantine hydrochloride 5 MG Oral TabletSCD292671f2-f221-4a3d-a110-a266a9527e049

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27241-070-0527241007005500 TABLET in 1 BOTTLE (27241-070-05) 500 tablet2015-08-270000-00-00NoNoCurrent
27241-070-062724100700660 TABLET in 1 BOTTLE (27241-070-06) 60 tablet2015-08-270000-00-00NoNoCurrent