FDA.reportPublic FDA data

MEMANTINE AND DONEPEZIL HYDROCHLORIDES

Product NDC
62559-207
11-digit product format
625590207
Labeler code
62559
Product ID
62559-207_cd8d0e95-24ac-43e1-9d43-bb081b4f341e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MEMANTINE AND DONEPEZIL HYDROCHLORIDES
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA208237
Marketing category
ANDA
Marketing start
2025-01-01
Substance
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Active strength
10; 21 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DONEPEZIL HYDROCHLORIDE10 mg/1
MEMANTINE HYDROCHLORIDE21 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3O2T2PJ89D, JY0WD0UA60
Rxcui1805420

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
62559-207-30MEMANTINE AND DONEPEZIL HYDROCHLORIDES30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-207-30EA - Each62559-2079c6feeff-74ea-4609-b5d4-1c81413d2cec12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-207MEMANTINE AND DONEPEZIL HYDROCHLORIDES CAPSULE, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20250101_c42a995d-cd0f-466c-8f47-43c7f32d9675.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1805420donepezil HCl 10 MG / memantine HCl 21 MG 24HR Extended Release Oral CapsulePSNc42a995d-cd0f-466c-8f47-43c7f32d96751
180542024 HR donepezil hydrochloride 10 MG / memantine hydrochloride 21 MG Extended Release Oral CapsuleSCDc42a995d-cd0f-466c-8f47-43c7f32d96751
1805420donepezil hydrochloride 10 MG / memantine hydrochloride 21 MG 24HR Extended Release Oral CapsuleSYc42a995d-cd0f-466c-8f47-43c7f32d96751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62559-207-306255902073030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-207-30) 2025-01-01NoNoCurrent