FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
71335-1732
11-digit product format
713351732
Labeler code
71335
Product ID
71335-1732_216899e3-38c6-4ac6-9ffc-ec5264ef4246
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

Additional Listing Data#

Finished product
Yes
Brand name base
Memantine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEMANTINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJY0WD0UA60
Rxcui996571

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94db636e-a074-45fd-8e8d-331920a99436Product name420250103
941773f8-a40e-0684-da08-ff9a143e6368Product name720231219
5b597f00-4538-4686-aa4e-3c60ed3788c8Product name220210511
1836e79a-a4d1-4087-2f2e-f878e8a1fef2Product name920151209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1732-1Memantine Hydrochloride30 in 1 BOTTLETABLET30103
71335-1732-2Memantine Hydrochloride60 in 1 BOTTLETABLET60103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1732-2EA - Each71335-1732a0a77d3c-0600-4be4-ad76-21c127bda87912021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1732MEMANTINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 2 package rows20231005_9cfddd01-6e1d-4ee0-9310-3fb371724e3d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996571memantine HCl 5 MG Oral TabletPSN9cfddd01-6e1d-4ee0-9310-3fb371724e3d103
996571memantine hydrochloride 5 MG Oral TabletSCD9cfddd01-6e1d-4ee0-9310-3fb371724e3d103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1732-17133517320130 TABLET in 1 BOTTLE (71335-1732-1) 30 tablet2020-11-110000-00-00NoNoCurrent
71335-1732-27133517320260 TABLET in 1 BOTTLE (71335-1732-2) 60 tablet2020-11-110000-00-00NoNoCurrent