FDA.reportPublic FDA data

donepezil hydrochloride

Product NDC
43547-276
11-digit product format
435470276
Labeler code
43547
Product ID
43547-276_dcfd9a94-e1bc-4b53-ae6f-0200ee714917
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
donepezil hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA200292
Marketing category
ANDA
Marketing start
2011-11-01
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
43547-276-03donepezil hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3015
43547-276-09donepezil hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9015
43547-276-11donepezil hydrochloride1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-276DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]12Current NDC, Legacy NDC, 3 package rows20230921_042a59ea-131a-4806-b0f4-2f791d4414e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN042a59ea-131a-4806-b0f4-2f791d4414e215
997223donepezil HCl 10 MG Oral TabletPSN41c095b6-acd9-4627-a813-bbca7ecafee515
997229donepezil HCl 5 MG Oral TabletPSN042a59ea-131a-4806-b0f4-2f791d4414e215
997223donepezil hydrochloride 10 MG Oral TabletSCD042a59ea-131a-4806-b0f4-2f791d4414e215
997223donepezil hydrochloride 10 MG Oral TabletSCD41c095b6-acd9-4627-a813-bbca7ecafee515
997229donepezil hydrochloride 5 MG Oral TabletSCD042a59ea-131a-4806-b0f4-2f791d4414e215
997223donepezil HCl 10 MG Oral TabletPSNc26d9bf3-e148-48bb-8f4f-e8c73804b3116
997223donepezil hydrochloride 10 MG Oral TabletSCDc26d9bf3-e148-48bb-8f4f-e8c73804b3116
997223donepezil HCl 10 MG Oral TabletPSN598bd4d0-18bc-2542-e053-2991aa0a07622
997223donepezil HCl 10 MG Oral TabletPSNcb1b3ed1-6e68-08e2-e053-2995a90a68c42
997223donepezil hydrochloride 10 MG Oral TabletSCD598bd4d0-18bc-2542-e053-2991aa0a07622
997223donepezil hydrochloride 10 MG Oral TabletSCDcb1b3ed1-6e68-08e2-e053-2995a90a68c42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-276-034354702760330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-276-03) 2011-11-010000-00-00NoNoCurrent
43547-276-094354702760990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-276-09) 2011-11-010000-00-00NoNoCurrent
43547-276-11435470276111000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-276-11) 2011-11-010000-00-00NoNoCurrent