FDA.reportPublic FDA data

memantine hydrochloride

Product NDC
0904-6735
11-digit product format
009046735
Labeler code
0904
Product ID
0904-6735_64e26acf-3799-4ad1-b91f-cf5766e5ada9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA206028
Marketing category
ANDA
Marketing start
2018-02-20
Substance
MEMANTINE HYDROCHLORIDE
Active strength
28 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 HYDROCHLORIDE28 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJY0WD0UA60
Rxcui996594, 996603, 996609, 996615

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
0904-6735-61memantine hydrochloride100 in 1 CARTONCAPSULE, EXTENDED RELEASE1006
0904-6735-61memantine hydrochloride1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6735-61EA - Each0904-6735f79d3403-215c-476b-97ad-2636ae216dff12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6735MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20250418_f6ce7cca-d245-44f2-986c-2a8d85dbb5fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996594memantine HCl 14 MG 24HR Extended Release Oral CapsulePSNf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996603memantine HCl 21 MG 24HR Extended Release Oral CapsulePSNf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996609memantine HCl 28 MG 24HR Extended Release Oral CapsulePSNf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996615memantine HCl 7 MG 24HR Extended Release Oral CapsulePSNf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
99659424 HR memantine hydrochloride 14 MG Extended Release Oral CapsuleSCDf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
99660324 HR memantine hydrochloride 21 MG Extended Release Oral CapsuleSCDf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
99660924 HR memantine hydrochloride 28 MG Extended Release Oral CapsuleSCDf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
99661524 HR memantine hydrochloride 7 MG Extended Release Oral CapsuleSCDf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996594memantine hydrochloride 14 MG 24 HR Extended Release Oral CapsuleSYf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996603memantine hydrochloride 21 MG 24 HR Extended Release Oral CapsuleSYf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996609memantine hydrochloride 28 MG 24 HR Extended Release Oral CapsuleSYf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996615memantine hydrochloride 7 MG 24 HR Extended Release Oral CapsuleSYf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6735-6100904673561100 BLISTER PACK in 1 CARTON (0904-6735-61) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK100 blister pack2018-02-200000-00-00NoNoCurrent