FDA.reportPublic FDA data

Memantine and Donepezil Hydrochlorides Extended-release

Product NDC
69238-1248
11-digit product format
692381248
Labeler code
69238
Product ID
69238-1248_acd577e1-312c-4d5a-85b5-bc50ef9de545
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine and Donepezil
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA208328
Marketing category
ANDA
Marketing start
2017-02-01
Substance
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Active strength
10; 14 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 HYDROCHLORIDE14 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJY0WD0UA60, 3O2T2PJ89D
Rxcui1599803, 1599805, 1805420, 1805425

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
69238-1248-3Memantine and Donepezil Hydrochlorides Extended-release30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3016
69238-1248-9Memantine and Donepezil Hydrochlorides Extended-release90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1248-3EA - Each69238-1248f8a7789f-698c-4c82-bead-161df50d605612025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1248MEMANTINE AND DONEPEZIL HYDROCHLORIDES EXTENDED-RELEASE (MEMANTINE AND DONEPEZIL) CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS NY LLC]16Current NDC, Legacy NDC, 2 package rows20250302_2335950c-be3b-4248-ad04-e9763aee47d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1599805donepezil HCl 10 MG / memantine HCl 14 MG 24HR Extended Release Oral CapsulePSN2335950c-be3b-4248-ad04-e9763aee47d216
1805420donepezil HCl 10 MG / memantine HCl 21 MG 24HR Extended Release Oral CapsulePSN2335950c-be3b-4248-ad04-e9763aee47d216
1599803donepezil HCl 10 MG / memantine HCl 28 MG 24HR Extended Release Oral CapsulePSN2335950c-be3b-4248-ad04-e9763aee47d216
1805425donepezil HCl 10 MG / memantine HCl 7 MG 24HR Extended Release Oral CapsulePSN2335950c-be3b-4248-ad04-e9763aee47d216
159980524 HR donepezil hydrochloride 10 MG / memantine hydrochloride 14 MG Extended Release Oral CapsuleSCD2335950c-be3b-4248-ad04-e9763aee47d216
180542024 HR donepezil hydrochloride 10 MG / memantine hydrochloride 21 MG Extended Release Oral CapsuleSCD2335950c-be3b-4248-ad04-e9763aee47d216
159980324 HR donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG Extended Release Oral CapsuleSCD2335950c-be3b-4248-ad04-e9763aee47d216
180542524 HR donepezil hydrochloride 10 MG / memantine hydrochloride 7 MG Extended Release Oral CapsuleSCD2335950c-be3b-4248-ad04-e9763aee47d216
1599805donepezil hydrochloride 10 MG / memantine hydrochloride 14 MG 24 HR Extended Release Oral CapsuleSY2335950c-be3b-4248-ad04-e9763aee47d216
1805420donepezil hydrochloride 10 MG / memantine hydrochloride 21 MG 24HR Extended Release Oral CapsuleSY2335950c-be3b-4248-ad04-e9763aee47d216
1599803donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG 24 HR Extended Release Oral CapsuleSY2335950c-be3b-4248-ad04-e9763aee47d216
1805425donepezil hydrochloride 10 MG / memantine hydrochloride 7 MG 24HR Extended Release Oral CapsuleSY2335950c-be3b-4248-ad04-e9763aee47d216

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69238-1248-36923812480330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-1248-3) 2017-02-010000-00-00NoNoCurrent
69238-1248-96923812480990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-1248-9) 2017-02-010000-00-00NoNoCurrent