Donepezil Hydrochloride

Product NDC
42291-246
11-digit product format
422910246
Labeler code
42291
Product ID
42291-246_d57a0ad3-8160-ce9f-e053-2a95a90a0c19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
donepezil hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
AvKARE
Application
ANDA203104
Marketing category
ANDA
Marketing start
2015-03-11
Marketing end
0000-00-00
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
23 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42291-246DDiscontinued by firm2026-08-17
excluded packagepackage42291-24642291-246-90DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42291-246-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42291-246-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42291-246-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42291-246-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42291-246-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42291-246-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42291-246-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42291-246-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42291-246-900efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42291-246-90ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42291-246-90367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42291-246-90557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203104-001DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203104-001AB

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-293f01610625f2…
2019-09-15 20:21 UTC2019-09A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203104-001DONEPEZIL HYDROCHLORIDE23MGTABLET / ORALAB2014-10-29e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203104-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203104-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203104-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203104-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203104-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203104-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203104-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203104-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203104-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203104-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203104-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203104-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203104-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203104-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203104-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203104-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203104-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203104-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203104-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203104-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203104-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203104-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A203104-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203104-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203104-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203104-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A203104-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203104-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203104-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203104-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203104-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203104-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203104-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203104-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203104-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203104-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203104-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203104-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203104-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203104-001AB1e64feba35796…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-246-90EA - Each42291-2460bfe2e44-c7ad-43cf-b854-9d12bde8f9c112015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DONEPEZIL HYDROCHLORIDEACTIVE INGREDIENT3O2T2PJ89DDONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [AVKARE, INC.]1
DONEPEZILACTIVE MOIETY8SSC91326PDONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [AVKARE, INC.]1
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [AVKARE, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [AVKARE, INC.]1
Hydroxypropyl Cellulose (type H)INACTIVE INGREDIENTRFW2ET671PDONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [AVKARE, INC.]1
HYPROMELLOSE 2208 (4000 MPA.S)INACTIVE INGREDIENT39J80LT57TDONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [AVKARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [AVKARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [AVKARE, INC.]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [AVKARE, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [AVKARE, INC.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [AVKARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [AVKARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [AVKARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [AVKARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [AVKARE, INC.]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [AVKARE, INC.]1

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEGolden State Medical Supply, Inc.a085ed33-c262-44ab-e053-2a95a90a55572026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203104
application number: ANDA203104
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEUpsher-Smith Laboratories, LLC12a755c5-1ad9-43d1-832a-eb2ff17bd6932026-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203104
application number: ANDA203104
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEBryant Ranch Prepack8090bff0-e0f0-4846-a2ab-cb28a0a2648d2024-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203104
application number: ANDA203104
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEBryant Ranch Prepackcaebc31c-5a35-4434-b7e2-80f6405383ca2024-01-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203104
application number: ANDA203104
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEProficient Rx LP32709bda-53d0-4d57-9f0b-3e1f28e39f252022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203104
application number: ANDA203104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-246-904229102469090 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-246-90) 2015-03-110000-00-00NoNoCurrent