memantine

Product NDC
62135-896
11-digit product format
621350896
Labeler code
62135
Product ID
62135-896_f3ba0986-42cf-a016-e053-2995a90a7c9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA090244
Marketing category
ANDA
Marketing start
2018-07-11
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
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
5b597f00-4538-4686-aa4e-3c60ed3788c8Product name220210511
1836e79a-a4d1-4087-2f2e-f878e8a1fef2Product name920151209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-896-60memantine60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-896-60EA - Each62135-89612b21ec1-19a6-4155-90ae-1aa599d9692d12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-896MEMANTINE TABLET [CHARTWELL RX, LLC]1Current NDC, 1 package rows20230203_6906b0b4-1944-40f0-844a-e0db72ba4675.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSN6906b0b4-1944-40f0-844a-e0db72ba46751
996571memantine HCl 5 MG Oral TabletPSN6906b0b4-1944-40f0-844a-e0db72ba46751
996561memantine hydrochloride 10 MG Oral TabletSCD6906b0b4-1944-40f0-844a-e0db72ba46751
996571memantine hydrochloride 5 MG Oral TabletSCD6906b0b4-1944-40f0-844a-e0db72ba46751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-896-606213508966060 TABLET in 1 BOTTLE (62135-896-60) 60 tablet2023-02-01NoNoHistorical