FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
27241-071
11-digit product format
272410071
Labeler code
27241
Product ID
27241-071_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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
5b597f00-4538-4686-aa4e-3c60ed3788c8Product name220210511
1836e79a-a4d1-4087-2f2e-f878e8a1fef2Product name920151209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27241-071-05Memantine Hydrochloride500 in 1 BOTTLETABLET5009
27241-071-06Memantine Hydrochloride60 in 1 BOTTLETABLET609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-071-05EA - Each27241-071941a7702-57ad-477b-866e-e26bae38806b12020-01-03
27241-071-06EA - Each27241-0717f76e37a-f764-4d12-91c3-71e5876bfa0312016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-071MEMANTINE 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 TabletPSNafc07196-be28-4521-afc0-d4aa5b6fd46d103
996561memantine hydrochloride 10 MG Oral TabletSCDafc07196-be28-4521-afc0-d4aa5b6fd46d103
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
996561memantine HCl 10 MG Oral TabletPSNbecb09dc-174d-4817-88d4-f38c8adcd3092
996561memantine hydrochloride 10 MG Oral TabletSCDbecb09dc-174d-4817-88d4-f38c8adcd3092
996561memantine HCl 10 MG Oral TabletPSN1289db0e-5179-d157-e063-6294a90ab7581
996561memantine HCl 10 MG Oral TabletPSN26571cc5-79b9-7703-e063-6394a90a0b7e1
996561memantine HCl 10 MG Oral TabletPSN30b8b982-db74-7cf4-e063-6394a90a3a6b1
996561memantine HCl 10 MG Oral TabletPSNd1c2ec99-7183-46e3-a96e-4f23e20b8b061
996561memantine hydrochloride 10 MG Oral TabletSCD1289db0e-5179-d157-e063-6294a90ab7581
996561memantine hydrochloride 10 MG Oral TabletSCD26571cc5-79b9-7703-e063-6394a90a0b7e1
996561memantine hydrochloride 10 MG Oral TabletSCD30b8b982-db74-7cf4-e063-6394a90a3a6b1
996561memantine hydrochloride 10 MG Oral TabletSCDd1c2ec99-7183-46e3-a96e-4f23e20b8b061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27241-071-0527241007105500 TABLET in 1 BOTTLE (27241-071-05) 500 tablet2015-08-270000-00-00NoNoCurrent
27241-071-062724100710660 TABLET in 1 BOTTLE (27241-071-06) 60 tablet2015-08-270000-00-00NoNoCurrent