FDA.reportPublic FDA data

Donepezil Hydrochloride

Product NDC
16571-779
11-digit product format
165710779
Labeler code
16571
Product ID
16571-779_b963d4b7-66f3-47d7-8671-7412d49e6cb3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA090056
Marketing category
ANDA
Marketing start
2011-05-31
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3O2T2PJ89D
Rxcui997223, 997229

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94db636e-a074-45fd-8e8d-331920a99436Product name420250103
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7Product name120221214
d7e50b51-94ef-29ef-8273-837d555048c1Product name920160811

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-779-03Donepezil Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
16571-779-09Donepezil Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902
16571-779-10Donepezil Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10002
16571-779-50Donepezil Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-779-03EA - Each16571-7794f1b54a3-169a-4017-8878-e82b6c0bc36e12021-11-09
16571-779-09EA - Each16571-7797938814b-088b-428c-a6d9-cc35229f120912021-11-09
16571-779-10EA - Each16571-7795078d7c2-55c0-4036-a854-bffba21af50312021-11-09
16571-779-50EA - Each16571-77998e6de95-f5c0-4553-a535-fd5c3862f8c112021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-779DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]2Current NDC, Legacy NDC, 4 package rows20240110_86b0c5a0-ff3c-4840-a4ac-82af922d58bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN1c6e8d7f-5219-4b6c-a1ce-2baff28c3d55100
997223donepezil hydrochloride 10 MG Oral TabletSCD1c6e8d7f-5219-4b6c-a1ce-2baff28c3d55100
997223donepezil HCl 10 MG Oral TabletPSN86b0c5a0-ff3c-4840-a4ac-82af922d58bf2
997229donepezil HCl 5 MG Oral TabletPSN86b0c5a0-ff3c-4840-a4ac-82af922d58bf2
997223donepezil hydrochloride 10 MG Oral TabletSCD86b0c5a0-ff3c-4840-a4ac-82af922d58bf2
997229donepezil hydrochloride 5 MG Oral TabletSCD86b0c5a0-ff3c-4840-a4ac-82af922d58bf2
997223donepezil HCl 10 MG Oral TabletPSN27be405c-83bf-5ccf-e063-6394a90adc4a1
997223donepezil hydrochloride 10 MG Oral TabletSCD27be405c-83bf-5ccf-e063-6394a90adc4a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16571-779-031657107790330 TABLET, FILM COATED in 1 BOTTLE (16571-779-03) 2011-05-310000-00-00NoNoCurrent
16571-779-091657107790990 TABLET, FILM COATED in 1 BOTTLE (16571-779-09) 2011-05-310000-00-00NoNoCurrent
16571-779-10165710779101000 TABLET, FILM COATED in 1 BOTTLE (16571-779-10) 2011-05-310000-00-00NoNoCurrent
16571-779-5016571077950500 TABLET, FILM COATED in 1 BOTTLE (16571-779-50) 2011-05-310000-00-00NoNoCurrent