Memantine Hydrochloride

Product NDC
63629-2513
11-digit product format
636292513
Labeler code
63629
Product ID
63629-2513_0259deac-9c4d-47b5-a33f-3f4ca4348efe
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
63629-2513-163629251301500 TABLET in 1 BOTTLE (63629-2513-1) 500 tablet2021-05-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Memantine HydrochlorideBryant Ranch Prepack2023-03-03HUMAN PRESCRIPTION DRUG LABEL102