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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200292-001DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31
A200292-002DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A200292-001AB
A200292-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31a50c72e98297…
2026-08-01 22:54:322026-06A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A200292-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A200292-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDEREMEDYREPACK INC.41c095b6-acd9-4627-a813-bbca7ecafee52026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDESolco Healthcare US, LLC48178cb4-4fee-47c0-88e9-a4f017f1f4482025-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDESolco Healthcare US, LLC042a59ea-131a-4806-b0f4-2f791d4414e22025-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
ndc (product): 43547-275
DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEDirect_Rx93dddf28-094b-dd8c-e053-2995a90a63e92025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEDirectRxcb1b3ed1-6e68-08e2-e053-2995a90a68c42025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDEBryant Ranch Prepackc26d9bf3-e148-48bb-8f4f-e8c73804b3112023-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDEA-S Medication Solutions5d46ef3c-0dee-4389-a2d5-997ea83428172023-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3O2T2PJ89DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
997223Internal RxNorm lookup
997229Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
042a59ea-131a-4806-b0f4-2f791d4414e2Available on FDA.report

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