FDA.reportPublic FDA data

Memantine hydrochloride

Product NDC
33342-219
11-digit product format
333420219
Labeler code
33342
Product ID
33342-219_1c695653-b7dd-40af-b5eb-a6e3ecbab14d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA206310
Marketing category
ANDA
Marketing start
2025-08-28
Substance
MEMANTINE HYDROCHLORIDE
Active strength
7 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 HYDROCHLORIDE7 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
33342-219-07Memantine hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302
33342-219-12Memantine hydrochloride10 in 1 CARTONCAPSULE, EXTENDED RELEASE102
33342-219-12Memantine hydrochloride10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE102

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996594memantine HCl 14 MG 24HR Extended Release Oral CapsulePSN62e32b0b-1eb2-424d-bfd2-d27ef27d35f32
996603memantine HCl 21 MG 24HR Extended Release Oral CapsulePSN62e32b0b-1eb2-424d-bfd2-d27ef27d35f32
996609memantine HCl 28 MG 24HR Extended Release Oral CapsulePSN62e32b0b-1eb2-424d-bfd2-d27ef27d35f32
996615memantine HCl 7 MG 24HR Extended Release Oral CapsulePSN62e32b0b-1eb2-424d-bfd2-d27ef27d35f32
99659424 HR memantine hydrochloride 14 MG Extended Release Oral CapsuleSCD62e32b0b-1eb2-424d-bfd2-d27ef27d35f32
99660324 HR memantine hydrochloride 21 MG Extended Release Oral CapsuleSCD62e32b0b-1eb2-424d-bfd2-d27ef27d35f32
99660924 HR memantine hydrochloride 28 MG Extended Release Oral CapsuleSCD62e32b0b-1eb2-424d-bfd2-d27ef27d35f32
99661524 HR memantine hydrochloride 7 MG Extended Release Oral CapsuleSCD62e32b0b-1eb2-424d-bfd2-d27ef27d35f32
996594memantine hydrochloride 14 MG 24 HR Extended Release Oral CapsuleSY62e32b0b-1eb2-424d-bfd2-d27ef27d35f32
996603memantine hydrochloride 21 MG 24 HR Extended Release Oral CapsuleSY62e32b0b-1eb2-424d-bfd2-d27ef27d35f32
996609memantine hydrochloride 28 MG 24 HR Extended Release Oral CapsuleSY62e32b0b-1eb2-424d-bfd2-d27ef27d35f32
996615memantine hydrochloride 7 MG 24 HR Extended Release Oral CapsuleSY62e32b0b-1eb2-424d-bfd2-d27ef27d35f32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-219-073334202190730 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-219-07) 2025-08-28NoNoCurrent
33342-219-123334202191210 BLISTER PACK in 1 CARTON (33342-219-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2025-08-28NoNoCurrent