MEMANTINE

Product NDC
60505-6162
11-digit product format
605056162
Labeler code
60505
Product ID
60505-6162_909dca28-d83f-dbc8-25a0-6f6a40ea2ccc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA209955
Marketing category
ANDA
Marketing start
2018-04-30
Substance
MEMANTINE HYDROCHLORIDE
Active strength
2 mg/mL
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEMANTINE HYDROCHLORIDE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJY0WD0UA60
Rxcui996740

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
60505-6162-5MEMANTINE1 in 1 CARTONSOLUTION16
60505-6162-5MEMANTINE360 mL in 1 BOTTLESOLUTION3606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6162-5ML - Milliliter60505-61621ff954b7-e8fa-4b85-aa75-39627e44786112018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6162MEMANTINE (MEMANTINE HYDROCHLORIDE) SOLUTION [APOTEX CORP.]6Current NDC, Legacy NDC, 2 package rows20250411_4076d3ef-d0a9-96c5-1a15-812c1e42929c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996740memantine HCl 2 MG in 1 mL Oral SolutionPSN4076d3ef-d0a9-96c5-1a15-812c1e42929c6
996740memantine hydrochloride 2 MG/ML Oral SolutionSCD4076d3ef-d0a9-96c5-1a15-812c1e42929c6
996740memantine HCl 10 MG per 5 ML Oral SolutionSY4076d3ef-d0a9-96c5-1a15-812c1e42929c6
996740memantine HCl 2 MG per 1 ML Oral SolutionSY4076d3ef-d0a9-96c5-1a15-812c1e42929c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-6162-5605056162051 BOTTLE in 1 CARTON (60505-6162-5) / 360 mL in 1 BOTTLE1 bottle2018-04-300000-00-00NoNoCurrent