Donepezil Hyrochloride

Product NDC
62980-907
11-digit product format
629800907
Labeler code
62980
Product ID
62980-907_eb0ec3ab-9077-4d91-a965-4b8ed556951f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Vivimed Labs Limited
Application
ANDA090551
Marketing category
ANDA
Marketing start
2019-11-05
Marketing end
0000-00-00
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62980-907DDiscontinued by firm2026-08-03
excluded packagepackage62980-90762980-907-04DDiscontinued by firm2026-08-03
excluded packagepackage62980-90762980-907-05DDiscontinued by firm2026-08-03
excluded packagepackage62980-90762980-907-07DDiscontinued by firm2026-08-03

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 · 48 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 packagepackage62980-907-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62980-907-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62980-907-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62980-907-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62980-907-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62980-907-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62980-907-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62980-907-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62980-907-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62980-907-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62980-907-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62980-907-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62980-907-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62980-907-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62980-907-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62980-907-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62980-907-07cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62980-907-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62980-907-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62980-907-07302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62980-907-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62980-907-04ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62980-907-07ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62980-907-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62980-907-040efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62980-907-070efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62980-907-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62980-907-04ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62980-907-07ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62980-907-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage62980-907-04367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage62980-907-07367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage62980-907-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage62980-907-04557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage62980-907-07557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage62980-907-05557ba5c1ecfa…9c80585c8c6e…

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
A090551-001DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31
A090551-002DONEPEZIL 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
A090551-001AB
A090551-002AB

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 UTC2026-02A090551-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090551-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090551-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090551-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090551-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090551-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090551-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090551-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090551-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090551-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090551-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090551-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090551-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090551-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090551-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090551-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090551-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090551-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090551-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A090551-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090551-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090551-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090551-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090551-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090551-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090551-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090551-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090551-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090551-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090551-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090551-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090551-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090551-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090551-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090551-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090551-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090551-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090551-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090551-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A090551-002DONEPEZIL 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 UTC2026-02A090551-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090551-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090551-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090551-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090551-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090551-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090551-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090551-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090551-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090551-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090551-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090551-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090551-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090551-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090551-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090551-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090551-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090551-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090551-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090551-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090551-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090551-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090551-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090551-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090551-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090551-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090551-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090551-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090551-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090551-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090551-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090551-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090551-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090551-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090551-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090551-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090551-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090551-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090551-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090551-002AB1782e0a99824c…