Memantine Hydrochloride

Product NDC
33342-066
11-digit product format
333420066
Labeler code
33342
Product ID
33342-066_0cc19195-8ba3-473e-aa2c-3bf990882db7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA202790
Marketing category
ANDA
Marketing start
2015-10-13
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 Hydrochloride
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
5b597f00-4538-4686-aa4e-3c60ed3788c8Product name220210511
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
1836e79a-a4d1-4087-2f2e-f878e8a1fef2Product name920151209
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-066-28Memantine Hydrochloride240 mL in 1 BOTTLESOLUTION2404

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-066-28ML - Milliliter33342-0662033048f-06ea-41ea-851f-2d4646c5d6df12018-04-19

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-066MEMANTINE HYDROCHLORIDE SOLUTION [MACLEODS PHARMACEUTICALS LIMITED]4Current NDC, Legacy NDC, 1 package rows20240415_42f0a9f2-4aa4-46fb-bc24-d3df843bb906.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996740memantine HCl 2 MG in 1 mL Oral SolutionPSN42f0a9f2-4aa4-46fb-bc24-d3df843bb9064
996740memantine hydrochloride 2 MG/ML Oral SolutionSCD42f0a9f2-4aa4-46fb-bc24-d3df843bb9064
996740memantine HCl 10 MG per 5 ML Oral SolutionSY42f0a9f2-4aa4-46fb-bc24-d3df843bb9064
996740memantine HCl 2 MG per 1 ML Oral SolutionSY42f0a9f2-4aa4-46fb-bc24-d3df843bb9064

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-066-2833342006628240 mL in 1 BOTTLE (33342-066-28) 240 ml2015-10-130000-00-00NoNoCurrent