FDA.reportPublic FDA data

Memantine and Donepezil Hydrochlorides Extended-release

Product NDC
73190-004
11-digit product format
731900004
Labeler code
73190
Product ID
73190-004_2d821398-bb64-e4dc-e063-6294a90a6c51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine and Donepezil
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
AvKARE
Application
ANDA208328
Marketing category
ANDA
Marketing start
2025-02-06
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 Hydrochlorides Extended-release
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
Unii3O2T2PJ89D, JY0WD0UA60
Rxcui1599803

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94db636e-a074-45fd-8e8d-331920a99436Product name420250103
941773f8-a40e-0684-da08-ff9a143e6368Product name720231219
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
73190-004-30Memantine and Donepezil Hydrochlorides Extended-release30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73190-004MEMANTINE AND DONEPEZIL HYDROCHLORIDES EXTENDED-RELEASE (MEMANTINE AND DONEPEZIL) CAPSULE, EXTENDED RELEASE [AVKARE]1Current NDC, 1 package rows20250209_2d821427-34ca-3c5d-e063-6394a90a9013.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1599803donepezil HCl 10 MG / memantine HCl 28 MG 24HR Extended Release Oral CapsulePSN2d821427-34ca-3c5d-e063-6394a90a90131
159980324 HR donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG Extended Release Oral CapsuleSCD2d821427-34ca-3c5d-e063-6394a90a90131
1599803donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG 24 HR Extended Release Oral CapsuleSY2d821427-34ca-3c5d-e063-6394a90a90131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73190-004-307319000043030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (73190-004-30) 2025-02-06NoNoCurrent