FDA.reportPublic FDA data

memantine hydrochloride and donepezil hydrochloride

Product NDC
69680-185
11-digit product format
696800185
Labeler code
69680
Product ID
69680-185_ffe5cf41-299a-49e5-a9b8-c9048c4861fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride and donepezil hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Vitruvias Therapeutics, Inc.
Application
ANDA216901
Marketing category
ANDA
Marketing start
2025-07-16
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 hydrochloride and donepezil hydrochloride
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
69680-185-30memantine hydrochloride and donepezil hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1599805donepezil HCl 10 MG / memantine HCl 14 MG 24HR Extended Release Oral CapsulePSNc888a2b2-92c6-46ae-99ea-21de616208b63
1599803donepezil HCl 10 MG / memantine HCl 28 MG 24HR Extended Release Oral CapsulePSNc888a2b2-92c6-46ae-99ea-21de616208b63
159980524 HR donepezil hydrochloride 10 MG / memantine hydrochloride 14 MG Extended Release Oral CapsuleSCDc888a2b2-92c6-46ae-99ea-21de616208b63
159980324 HR donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG Extended Release Oral CapsuleSCDc888a2b2-92c6-46ae-99ea-21de616208b63
1599805donepezil hydrochloride 10 MG / memantine hydrochloride 14 MG 24 HR Extended Release Oral CapsuleSYc888a2b2-92c6-46ae-99ea-21de616208b63
1599803donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG 24 HR Extended Release Oral CapsuleSYc888a2b2-92c6-46ae-99ea-21de616208b63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69680-185-306968001853030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69680-185-30) 2025-07-16NoNoCurrent