FDA.reportPublic FDA data

Donepezil Hydrochloride

Product NDC
68788-8208
11-digit product format
687888208
Labeler code
68788
Product ID
68788-8208_cbb2b198-c1dd-4d48-8937-b3b58deba369
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090056
Marketing category
ANDA
Marketing start
2022-06-03
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
68788-8208-3Donepezil Hydrochloride30 in 1 BOTTLETABLET, FILM COATED305
68788-8208-6Donepezil Hydrochloride60 in 1 BOTTLETABLET, FILM COATED605
68788-8208-9Donepezil Hydrochloride90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8208-3EA - Each68788-8208d7759c83-4431-4212-b67d-974c882d931512022-07-06
68788-8208-6EA - Each68788-8208ba1a4ea8-8707-4003-85b0-858e202be0d912022-07-06
68788-8208-9EA - Each68788-82083de604a9-30c9-460f-b77d-4b94c3f8993812022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8208DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 3 package rows20250403_8138f616-83f3-4c47-84ef-1bce2db339f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997229donepezil HCl 5 MG Oral TabletPSN8138f616-83f3-4c47-84ef-1bce2db339f75
997229donepezil hydrochloride 5 MG Oral TabletSCD8138f616-83f3-4c47-84ef-1bce2db339f75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8208-36878882080330 TABLET, FILM COATED in 1 BOTTLE (68788-8208-3) 2022-06-030000-00-00NoNoCurrent
68788-8208-66878882080660 TABLET, FILM COATED in 1 BOTTLE (68788-8208-6) 2022-06-030000-00-00NoNoCurrent
68788-8208-96878882080990 TABLET, FILM COATED in 1 BOTTLE (68788-8208-9) 2022-06-030000-00-00NoNoCurrent