FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
29300-172
11-digit product format
293000172
Labeler code
29300
Product ID
29300-172_16cd3370-8ddc-4dbb-82b3-98e128fb3482
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA200022
Marketing category
ANDA
Marketing start
2015-11-01
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEMANTINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJY0WD0UA60
Rxcui996561, 996571

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94db636e-a074-45fd-8e8d-331920a99436Product name420250103
941773f8-a40e-0684-da08-ff9a143e6368Product name720231219
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
5b597f00-4538-4686-aa4e-3c60ed3788c8Product name220210511
1836e79a-a4d1-4087-2f2e-f878e8a1fef2Product name920151209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29300-172-05Memantine Hydrochloride500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5005
29300-172-16Memantine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-172MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5Current NDC, Legacy NDC, 2 package rows20201212_ff74edcb-d7ed-4b70-8f22-4cb5ccc58f90.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSNca619439-f4ca-43f1-9261-9aa2b6dc74509
996561memantine hydrochloride 10 MG Oral TabletSCDca619439-f4ca-43f1-9261-9aa2b6dc74509
996561memantine HCl 10 MG Oral TabletPSN255e52a7-68c2-4f2a-8dc4-46f95d68c5685
996561memantine HCl 10 MG Oral TabletPSNff74edcb-d7ed-4b70-8f22-4cb5ccc58f905
996571memantine HCl 5 MG Oral TabletPSNff74edcb-d7ed-4b70-8f22-4cb5ccc58f905
996561memantine hydrochloride 10 MG Oral TabletSCD255e52a7-68c2-4f2a-8dc4-46f95d68c5685
996561memantine hydrochloride 10 MG Oral TabletSCDff74edcb-d7ed-4b70-8f22-4cb5ccc58f905
996571memantine hydrochloride 5 MG Oral TabletSCDff74edcb-d7ed-4b70-8f22-4cb5ccc58f905
996561memantine HCl 10 MG Oral TabletPSN11d27c75-fdc0-f9da-e063-6394a90ac6b02
996571memantine HCl 5 MG Oral TabletPSN11d27c75-fdc0-f9da-e063-6394a90ac6b02
996561memantine hydrochloride 10 MG Oral TabletSCD11d27c75-fdc0-f9da-e063-6394a90ac6b02
996571memantine hydrochloride 5 MG Oral TabletSCD11d27c75-fdc0-f9da-e063-6394a90ac6b02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
29300-172-0529300017205500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-172-05) 2015-11-010000-00-00NoNoCurrent
29300-172-162930001721660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-172-16) 2015-11-010000-00-00NoNoCurrent