Memantine Hydrochloride

Product NDC
50090-6400
11-digit product format
500906400
Labeler code
50090
Product ID
50090-6400_0f1a6f0c-50ec-4e4b-a804-5385a2fd2e40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
JY0WD0UA60MEMANTINE HYDROCHLORIDE41100-52-1MEMANTINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6400-05009064000090 TABLET in 1 BOTTLE (50090-6400-0) 90 tablet2023-03-16NoNoHistorical
50090-6400-15009064000160 TABLET in 1 BOTTLE (50090-6400-1) 60 tablet2023-03-16NoNoHistorical
50090-6400-250090640002180 TABLET in 1 BOTTLE (50090-6400-2) 180 tablet2023-03-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Memantine HydrochlorideA-S Medication Solutions2023-04-19Human Prescription Drug Label1