DONEPEZIL HYDROCHLORIDE

Product NDC
71209-020
11-digit product format
712090020
Labeler code
71209
Product ID
71209-020_e33aac76-604d-43cb-8be4-d58ce3b2b6f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
donepezil hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cadila Pharmaceuticals Limited
Application
ANDA204609
Marketing category
ANDA
Marketing start
2017-01-30
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
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7Product name120221214
d7e50b51-94ef-29ef-8273-837d555048c1Product name920160811

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71209-020-01DONEPEZIL HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED307
71209-020-04DONEPEZIL HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED907
71209-020-11DONEPEZIL HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED10007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71209-020DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CADILA PHARMACEUTICALS LIMITED]7Current NDC, Legacy NDC, 3 package rows20221228_37aa1285-774a-4714-a4af-4e3fa9fa7f55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN37aa1285-774a-4714-a4af-4e3fa9fa7f557
997229donepezil HCl 5 MG Oral TabletPSN37aa1285-774a-4714-a4af-4e3fa9fa7f557
997223donepezil hydrochloride 10 MG Oral TabletSCD37aa1285-774a-4714-a4af-4e3fa9fa7f557
997229donepezil hydrochloride 5 MG Oral TabletSCD37aa1285-774a-4714-a4af-4e3fa9fa7f557

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71209-020-017120900200130 TABLET, FILM COATED in 1 BOTTLE (71209-020-01) 2018-11-240000-00-00NoNoCurrent
71209-020-047120900200490 TABLET, FILM COATED in 1 BOTTLE (71209-020-04) 2018-11-240000-00-00NoNoCurrent
71209-020-11712090020111000 TABLET, FILM COATED in 1 BOTTLE (71209-020-11) 2018-11-240000-00-00NoNoCurrent