Memantine Hydrochloride

Product NDC
71335-1603
11-digit product format
713351603
Labeler code
71335
Product ID
71335-1603_7a5a4451-bd05-4f77-9c6c-563119465803
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090961
Marketing category
ANDA
Marketing start
2019-02-28
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
71335-1603-17133516030130 TABLET in 1 BOTTLE (71335-1603-1) 30 tablet2020-07-09NoNoHistorical
71335-1603-27133516030260 TABLET in 1 BOTTLE (71335-1603-2) 60 tablet2020-05-18NoNoHistorical
71335-1603-37133516030390 TABLET in 1 BOTTLE (71335-1603-3) 90 tablet2020-12-14NoNoHistorical
71335-1603-471335160304180 TABLET in 1 BOTTLE (71335-1603-4) 180 tablet2021-12-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Memantine HydrochlorideBryant Ranch Prepack2023-03-30HUMAN PRESCRIPTION DRUG LABEL4