FDA.reportPublic FDA data

Donepezil Hydrochloride

Product NDC
68788-8711
11-digit product format
687888711
Labeler code
68788
Product ID
68788-8711_c9fdb857-2048-40fe-a3d1-4e89dda6cdf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078662
Marketing category
ANDA
Marketing start
2024-07-08
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Donepezil Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DONEPEZIL HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3O2T2PJ89D
Rxcui997229

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
68788-8711-3Donepezil Hydrochloride30 in 1 BOTTLETABLET303
68788-8711-6Donepezil Hydrochloride60 in 1 BOTTLETABLET603
68788-8711-9Donepezil Hydrochloride90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8711-3EA - Each68788-871176192a7a-0ac4-4606-bf51-43ec25a7de7812024-09-09
68788-8711-6EA - Each68788-8711ee2eedc6-05fb-4fa8-b244-2e5702641b8f12024-09-09
68788-8711-9EA - Each68788-8711d6f89586-785a-4d91-8846-0f396566a0b912024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8711DONEPEZIL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 3 package rows20250406_ee54a472-6783-41df-b8bb-9c3e4c996907.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997229donepezil HCl 5 MG Oral TabletPSNee54a472-6783-41df-b8bb-9c3e4c9969073
997229donepezil hydrochloride 5 MG Oral TabletSCDee54a472-6783-41df-b8bb-9c3e4c9969073

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8711-36878887110330 TABLET in 1 BOTTLE (68788-8711-3) 30 tablet2024-07-08NoNoHistorical
68788-8711-66878887110660 TABLET in 1 BOTTLE (68788-8711-6) 60 tablet2024-07-08NoNoHistorical
68788-8711-96878887110990 TABLET in 1 BOTTLE (68788-8711-9) 90 tablet2024-07-08NoNoHistorical