donepezil / Memantine Extended Release Oral Capsule

Brand(s)
Namzaric
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Forest Laboratories, Inc (2015-02-25)
Oldest Current Product
2014-12-24
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL CAPSULE\DONEPEZIL:MEMANTINE
FDAOB
ORAL\CAPSULE, EXTENDED RELEASE\DONEPEZIL HYDROCHLORIDE: MEMANTINE HYDROCHLORIDE
SPL Active
ORAL\CAPSULE\DONEPEZIL HYDROCHLORIDE: MEMANTINE HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE\DONEPEZIL: MEMANTINE

product(s) by strength(s)

24 hr donepezil hydrochloride 10 mg / memantine hydrochloride 14 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004561214NamzaricNDAForest Laboratories, Inc2014-12-24DONEPEZIL HYDROCHLORIDE, MEMANTINE HYDROCHLORIDEORALCAPSULENDA20643990fedc32-19e5-480c-afc6-f35a5cf4b9aa

24 hr donepezil hydrochloride 10 mg / memantine hydrochloride 28 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004561228NamzaricNDAForest Laboratories, Inc2014-12-24DONEPEZIL HYDROCHLORIDE, MEMANTINE HYDROCHLORIDEORALCAPSULENDA20643990fedc32-19e5-480c-afc6-f35a5cf4b9aa

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA206439NAMZARICFOREST LABORATORIES LLC2014-12-23p8362085, MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
p8338486, MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
p8598233, SUBSTANCE
p8580858, MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
p8039009, MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
p8058291, MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
p8168209, SUBSTANCE
p8283379, MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
p8338485, SUBSTANCE
p5061703, MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
p8173708, MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
p8329752, SUBSTANCE
p8293794, SUBSTANCE
NDA206439_001, NDA206439_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA206439_001RXMEMANTINE HYDROCHLORIDE (14MG), DONEPEZIL HYDROCHLORIDE (10MG)ORALCAPSULE, EXTENDED RELEASEFalse2014-12-23NAMZARIC
2NDA206439_002RXDONEPEZIL HYDROCHLORIDE (10MG), MEMANTINE HYDROCHLORIDE (28MG)ORALCAPSULE, EXTENDED RELEASETrue2014-12-23NAMZARIC

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5061703 (view patent)2015-04-11NDA206439, NDA021487, NDA021627, NDA022525Memantine Extended Release Oral Capsule
Memantine Oral Solution
Memantine Oral Tablet
2p8039009 (view patent)2029-03-24NDA206439, NDA022525Memantine Extended Release Oral Capsule
3p8058291 (view patent)2029-12-05NDA206439
4p8168209 (view patent)2025-11-22NDA206439, NDA022525Memantine Extended Release Oral Capsule
5p8173708 (view patent)2025-11-22NDA206439, NDA022525Memantine Extended Release Oral Capsule
6p8283379 (view patent)2025-11-22NDA206439, NDA022525Memantine Extended Release Oral Capsule
7p8293794 (view patent)2025-11-22NDA206439
8p8329752 (view patent)2025-11-22NDA206439, NDA022525Memantine Extended Release Oral Capsule
9p8338485 (view patent)2025-11-22NDA206439
10p8338486 (view patent)2025-11-22NDA206439
11p8362085 (view patent)2025-11-22NDA206439, NDA022525Memantine Extended Release Oral Capsule
12p8580858 (view patent)2025-11-22NDA206439
13p8598233 (view patent)2025-11-22NDA206439, NDA022525Memantine Extended Release Oral Capsule

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
190fedc32-19e5-480c-afc6-f35a5cf4b9aa (view SPL)These highlights do not include all the information needed to use NAMZARIC capsules safely and effectively. See full prescribing information for NAMZARIC capsules. NAMZARIC (memantine hydrochloride extended-release and donepezil hydrochloride) capsules, for oral useInitial U.S. Approval: 2014prescriptionHuman PrescriptionForest Laboratories, IncANALYSIS, API MANUFACTURE, PACK2015-02-255004561214, 004561228

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII