FDA.reportPublic FDA data

Memantine hydrochloride

Product NDC
68180-229
11-digit product format
681800229
Labeler code
68180
Product ID
68180-229_392d48fd-7c93-40f3-9ab0-d0f304b7e439
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA090051
Marketing category
ANDA
Marketing start
2015-07-13
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
5b597f00-4538-4686-aa4e-3c60ed3788c8Product name220210511
1836e79a-a4d1-4087-2f2e-f878e8a1fef2Product name920151209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-229-07Memantine hydrochloride60 in 1 BOTTLETABLET, FILM COATED6013
68180-229-11Memantine hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED1013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-229-07EA - Each68180-229e51fff3f-21d4-432b-8fc5-3ab0bf4b52c212015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEMANTINE HYDROCHLORIDEACTIVE INGREDIENTJY0WD0UA60MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]2
MEMANTINEACTIVE MOIETYW8O17SJF3TMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-229MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]11Current NDC, Legacy NDC, 2 package rows20250528_1b4a0162-9cb4-4ba6-8c02-95c2955734ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSN1b4a0162-9cb4-4ba6-8c02-95c2955734ae13
996571memantine HCl 5 MG Oral TabletPSN1b4a0162-9cb4-4ba6-8c02-95c2955734ae13
996561memantine hydrochloride 10 MG Oral TabletSCD1b4a0162-9cb4-4ba6-8c02-95c2955734ae13
996571memantine hydrochloride 5 MG Oral TabletSCD1b4a0162-9cb4-4ba6-8c02-95c2955734ae13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-229-076818002290760 TABLET, FILM COATED in 1 BOTTLE (68180-229-07) 2015-07-130000-00-00NoNoCurrent
68180-229-116818002291110 in 1 BLISTER PACKHistorical
68180-229-136818002291310 BLISTER PACK in 1 CARTON (68180-229-13) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68180-229-11) 10 blister pack2015-07-130000-00-00NoNoCurrent