FDA.reportPublic FDA data

Donepezil hydrochloride

Product NDC
42799-954
11-digit product format
427990954
Labeler code
42799
Product ID
42799-954_19147d81-49ac-463e-8643-26dace803ea5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Edenbridge Pharmaceuticals LLC.
Application
ANDA203713
Marketing category
ANDA
Marketing start
2016-02-19
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
23 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Donepezil hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DONEPEZIL HYDROCHLORIDE23 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3O2T2PJ89D
Rxcui1100184

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94db636e-a074-45fd-8e8d-331920a99436Product name420250103
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7Product name120221214
d7e50b51-94ef-29ef-8273-837d555048c1Product name920160811

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42799-954-01Donepezil hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
42799-954-02Donepezil hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42799-954-01EA - Each42799-95410cb5340-5c8b-4c08-a247-73f9c9fe58e912024-01-04
42799-954-02EA - Each42799-954d31b6adb-8c2c-44e6-95ef-7d232dff83d712024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42799-954DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [EDENBRIDGE PHARMACEUTICALS LLC.]1Current NDC, 2 package rows20231208_11404dc3-1bde-4d4e-8386-006b67ee19dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100184donepezil HCl 23 MG Oral TabletPSN11404dc3-1bde-4d4e-8386-006b67ee19dd2
1100184donepezil hydrochloride 23 MG Oral TabletSCD11404dc3-1bde-4d4e-8386-006b67ee19dd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42799-954-014279909540130 TABLET, FILM COATED in 1 BOTTLE (42799-954-01) 2023-12-05NoNoHistorical
42799-954-024279909540290 TABLET, FILM COATED in 1 BOTTLE (42799-954-02) 2023-12-05NoNoHistorical