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

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A200292-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200292-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200292-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200292-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200292-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200292-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200292-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200292-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200292-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200292-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200292-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200292-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200292-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200292-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200292-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200292-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200292-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200292-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200292-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200292-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200292-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200292-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200292-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200292-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200292-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200292-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200292-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200292-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200292-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200292-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200292-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200292-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200292-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200292-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200292-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200292-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200292-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200292-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200292-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A200292-002AB1782e0a99824c…

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 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
43547-276-03donepezil 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-276-03EA - Each43547-2764cd6a53e-1d20-4293-84cc-0633404beed412012-07-24
43547-276-09EA - Each43547-276c11c81fa-1608-495d-ae73-12d48397a93812012-07-24
43547-276-11EA - Each43547-276e6e28b51-902f-4196-9666-50604a7671e312012-07-24

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
43547-276DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]12Current NDC, Legacy NDC, 3 package rows20230921_042a59ea-131a-4806-b0f4-2f791d4414e2.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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): 43547-276
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

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