Memantine Hydrochloride

Product NDC
71610-911
11-digit product format
716100911
Labeler code
71610
Product ID
71610-911_3662a842-9689-b3e3-e063-6394a90a15a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090961
Marketing category
ANDA
Marketing start
2019-02-28
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
71610-911-60Memantine Hydrochloride90 in 1 BOTTLETABLET901
71610-911-70Memantine Hydrochloride120 in 1 BOTTLETABLET1201
71610-911-80Memantine Hydrochloride180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-911-60EA - Each71610-91181b1bb6b-252f-4285-ae7b-a4a08cbf757c12025-07-08
71610-911-70EA - Each71610-9119fea5b2a-1b5f-43a3-9ccb-7c6cc6c801f712025-07-08
71610-911-80EA - Each71610-911808f2560-19fb-4b1b-b153-6127849f224a12025-07-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996571memantine HCl 5 MG Oral TabletPSN3662b11a-354a-b683-e063-6394a90a00861
996571memantine hydrochloride 5 MG Oral TabletSCD3662b11a-354a-b683-e063-6394a90a00861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-911-607161009116090 TABLET in 1 BOTTLE (71610-911-60) 90 tablet2025-05-30NoNoHistorical
71610-911-7071610091170120 TABLET in 1 BOTTLE (71610-911-70) 120 tablet2025-05-30NoNoHistorical
71610-911-8071610091180180 TABLET in 1 BOTTLE (71610-911-80) 180 tablet2025-05-30NoNoHistorical