FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
71335-1899
11-digit product format
713351899
Labeler code
71335
Product ID
71335-1899_ab7d2d43-bf63-43e4-bc4c-25ad6291d4e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206528
Marketing category
ANDA
Marketing start
2015-08-27
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Memantine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEMANTINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJY0WD0UA60
Rxcui996561

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
71335-1899-1Memantine Hydrochloride30 in 1 BOTTLETABLET30103
71335-1899-2Memantine Hydrochloride60 in 1 BOTTLETABLET60103
71335-1899-3Memantine Hydrochloride90 in 1 BOTTLETABLET90103
71335-1899-4Memantine Hydrochloride180 in 1 BOTTLETABLET180103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1899-2EA - Each71335-18995eeecfc6-7da4-46c9-adf8-a8a8b462fce012023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1899MEMANTINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 4 package rows20231116_afc07196-be28-4521-afc0-d4aa5b6fd46d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSNafc07196-be28-4521-afc0-d4aa5b6fd46d103
996561memantine hydrochloride 10 MG Oral TabletSCDafc07196-be28-4521-afc0-d4aa5b6fd46d103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1899-17133518990130 TABLET in 1 BOTTLE (71335-1899-1) 30 tablet2021-06-250000-00-00NoNoCurrent
71335-1899-27133518990260 TABLET in 1 BOTTLE (71335-1899-2) 60 tablet2022-02-140000-00-00NoNoCurrent
71335-1899-37133518990390 TABLET in 1 BOTTLE (71335-1899-3) 90 tablet2021-08-090000-00-00NoNoCurrent
71335-1899-471335189904180 TABLET in 1 BOTTLE (71335-1899-4) 180 tablet2021-12-230000-00-00NoNoCurrent