Memantine Hydrochloride

Product NDC
71335-2013
11-digit product format
713352013
Labeler code
71335
Product ID
71335-2013_24aceb1f-1a08-4643-ac9d-713874e86ab6
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
5 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
71335-2013-17133520130130 TABLET in 1 BOTTLE (71335-2013-1) 30 tablet2022-02-10NoNoHistorical
71335-2013-27133520130228 TABLET in 1 BOTTLE (71335-2013-2) 28 tablet2022-02-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Memantine HydrochlorideBryant Ranch Prepack2023-03-24HUMAN PRESCRIPTION DRUG LABEL101