donepezil hydrochloride

Product NDC
70518-1666
11-digit product format
705181666
Labeler code
70518
Product ID
70518-1666_4e3cd922-0ae5-3fad-e063-6294a90a1a91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
donepezil hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA200292
Marketing category
ANDA
Marketing start
2018-11-12
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3O2T2PJ89D
Rxcui997223

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
70518-1666-0donepezil hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9015
70518-1666-1donepezil hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN41c095b6-acd9-4627-a813-bbca7ecafee515
997223donepezil hydrochloride 10 MG Oral TabletSCD41c095b6-acd9-4627-a813-bbca7ecafee515

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1666-07051816660090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1666-0) 2018-11-120000-00-00NoNoCurrent
70518-1666-170518166601100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1666-1) 2026-03-29NoNoCurrent