Memantine Hydrochloride

Product NDC
71335-1908
11-digit product format
713351908
Labeler code
71335
Product ID
71335-1908_417d1056-9d1c-47c4-a065-ca8bd6397982
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090058
Marketing category
ANDA
Marketing start
2015-07-11
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 formatDescriptionMarketing startSampleExclude flagStatus
71335-1908-17133519080130 TABLET, FILM COATED in 1 BOTTLE (71335-1908-1) 2021-07-15NoNoHistorical
71335-1908-27133519080260 TABLET, FILM COATED in 1 BOTTLE (71335-1908-2) 2021-07-15NoNoHistorical
71335-1908-37133519080390 TABLET, FILM COATED in 1 BOTTLE (71335-1908-3) 2021-07-15NoNoHistorical
71335-1908-471335190804180 TABLET, FILM COATED in 1 BOTTLE (71335-1908-4) 2021-07-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Memantine HydrochlorideBryant Ranch Prepack2024-04-05HUMAN PRESCRIPTION DRUG LABEL102