FDA.reportPublic FDA data

Memantine and Donepezil

Product NDC
33342-313
11-digit product format
333420313
Labeler code
33342
Product ID
33342-313_3d9a23dc-8cbe-47c3-a048-70d86cb9dc14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine and Donepezil
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA208672
Marketing category
ANDA
Marketing start
2025-07-15
Substance
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Active strength
10; 28 mg/1; mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], 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 and Donepezil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DONEPEZIL HYDROCHLORIDE10 mg/1
MEMANTINE HYDROCHLORIDE28 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJY0WD0UA60, 3O2T2PJ89D
Rxcui1599803, 1599805

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94db636e-a074-45fd-8e8d-331920a99436Product name420250103
941773f8-a40e-0684-da08-ff9a143e6368Product name720231219
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7Product name120221214
5b597f00-4538-4686-aa4e-3c60ed3788c8Product name220210511
d7e50b51-94ef-29ef-8273-837d555048c1Product name920160811
1836e79a-a4d1-4087-2f2e-f878e8a1fef2Product name920151209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-313-07Memantine and Donepezil30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
33342-313-10Memantine and Donepezil90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901
33342-313-56Memantine and Donepezil10 in 1 CARTONCAPSULE, EXTENDED RELEASE101
33342-313-56Memantine and Donepezil14 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE141

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1599805donepezil HCl 10 MG / memantine HCl 14 MG 24HR Extended Release Oral CapsulePSN3d9a23dc-8cbe-47c3-a048-70d86cb9dc141
1599803donepezil HCl 10 MG / memantine HCl 28 MG 24HR Extended Release Oral CapsulePSN3d9a23dc-8cbe-47c3-a048-70d86cb9dc141
159980524 HR donepezil hydrochloride 10 MG / memantine hydrochloride 14 MG Extended Release Oral CapsuleSCD3d9a23dc-8cbe-47c3-a048-70d86cb9dc141
159980324 HR donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG Extended Release Oral CapsuleSCD3d9a23dc-8cbe-47c3-a048-70d86cb9dc141
1599805donepezil hydrochloride 10 MG / memantine hydrochloride 14 MG 24 HR Extended Release Oral CapsuleSY3d9a23dc-8cbe-47c3-a048-70d86cb9dc141
1599803donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG 24 HR Extended Release Oral CapsuleSY3d9a23dc-8cbe-47c3-a048-70d86cb9dc141

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-313-073334203130730 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-313-07) 2025-07-15NoNoCurrent
33342-313-103334203131090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-313-10) 2025-07-15NoNoCurrent
33342-313-563334203135610 BLISTER PACK in 1 CARTON (33342-313-56) / 14 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2025-07-15NoNoCurrent