Memantine Hydrochloride

Product NDC
68999-943
11-digit product format
689990943
Labeler code
68999
Product ID
68999-943_4a2cbed1-d548-b830-e063-6394a90a0ee6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell Governmental & Specialty RX, LLC.
Application
ANDA204033
Marketing category
ANDA
Marketing start
2015-10-13
Substance
MEMANTINE HYDROCHLORIDE
Active strength
2 mg/mL
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 HYDROCHLORIDE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJY0WD0UA60
Rxcui996740

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
68999-943-05Memantine Hydrochloride5 mL in 1 CUPSOLUTION51
68999-943-24Memantine Hydrochloride10 in 1 TRAYSOLUTION101
68999-943-24Memantine Hydrochloride2 in 1 BOXSOLUTION21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68999-943-05ML - Milliliter68999-943da0ff492-8c6c-4c9e-b025-1f07f629c78112026-04-20
68999-943-24ML - Milliliter68999-943126b9a48-eaf6-426c-b05c-3213dbaecc8b12026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996740memantine HCl 2 MG in 1 mL Oral SolutionPSNd1f97615-e888-421e-b50a-95a87a1965ff1
996740memantine hydrochloride 2 MG/ML Oral SolutionSCDd1f97615-e888-421e-b50a-95a87a1965ff1
996740memantine HCl 10 MG per 5 ML Oral SolutionSYd1f97615-e888-421e-b50a-95a87a1965ff1
996740memantine HCl 2 MG per 1 ML Oral SolutionSYd1f97615-e888-421e-b50a-95a87a1965ff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68999-943-05689990943055 mL in 1 CUP5 mlHistorical
68999-943-24689990943242 TRAY in 1 BOX (68999-943-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-943-05) 2 tray2026-02-02NoNoHistorical