FDA.reportPublic FDA data

donepezil hydrochloride

Product NDC
43547-275
11-digit product format
435470275
Labeler code
43547
Product ID
43547-275_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
5 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 HYDROCHLORIDE5 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
43547-275-03donepezil hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3015
43547-275-09donepezil hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9015
43547-275-11donepezil hydrochloride1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-275-03EA - Each43547-275283e1a5d-4181-4daf-a241-f7fd9dccb0b412012-07-24
43547-275-09EA - Each43547-2758fc92fc8-3dde-45d2-a666-3bdfd78e8fb712012-07-24
43547-275-11EA - Each43547-275711b41ab-9f43-443e-a0a7-ff0e3fa5988112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
donepezil hydrochlorideACTIVE INGREDIENT3O2T2PJ89DDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]3
donepezilACTIVE MOIETY8SSC91326PDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]3
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]3
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]3
fd&c blue no. 2INACTIVE INGREDIENTL06K8R7DQKDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]3
ferric oxide redINACTIVE INGREDIENT1K09F3G675DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]3
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]3
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]3
hypromellosesINACTIVE INGREDIENT3NXW29V3WODONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]3
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]3
magnesium stearateINACTIVE INGREDIENT70097M6I30DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]3
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ADONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]3
starch, cornINACTIVE INGREDIENTO8232NY3SJDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-275DONEPEZIL 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
997229donepezil HCl 5 MG Oral TabletPSN042a59ea-131a-4806-b0f4-2f791d4414e215
997223donepezil hydrochloride 10 MG Oral TabletSCD042a59ea-131a-4806-b0f4-2f791d4414e215
997229donepezil hydrochloride 5 MG Oral TabletSCD042a59ea-131a-4806-b0f4-2f791d4414e215
997229donepezil HCl 5 MG Oral TabletPSN5d46ef3c-0dee-4389-a2d5-997ea83428177
997229donepezil hydrochloride 5 MG Oral TabletSCD5d46ef3c-0dee-4389-a2d5-997ea83428177
997229donepezil HCl 5 MG Oral TabletPSN93dddf28-094b-dd8c-e053-2995a90a63e93
997229donepezil hydrochloride 5 MG Oral TabletSCD93dddf28-094b-dd8c-e053-2995a90a63e93
997229donepezil HCl 5 MG Oral TabletPSN1e18da51-1dd3-a3fd-e063-6294a90ad0be1
997229donepezil HCl 5 MG Oral TabletPSN92fce88e-9fdf-43a8-e053-2995a90a58671
997229donepezil HCl 5 MG Oral TabletPSN93dd96a4-3a74-ea7e-e053-2a95a90ab0a41
997229donepezil hydrochloride 5 MG Oral TabletSCD1e18da51-1dd3-a3fd-e063-6294a90ad0be1
997229donepezil hydrochloride 5 MG Oral TabletSCD92fce88e-9fdf-43a8-e053-2995a90a58671
997229donepezil hydrochloride 5 MG Oral TabletSCD93dd96a4-3a74-ea7e-e053-2a95a90ab0a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-275-034354702750330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-275-03) 2011-11-010000-00-00NoNoCurrent
43547-275-094354702750990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-275-09) 2011-11-010000-00-00NoNoCurrent
43547-275-11435470275111000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-275-11) 2011-11-010000-00-00NoNoCurrent