Home NDC 69150-415 Donepezil Hydrochloride
Product NDC 69150-415
11-digit product format 691500415
Labeler code 69150
Product ID 69150-415_4c4bfc6d-a15c-4c6d-93c4-301466517b86
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name donepezil hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler BIOMES PHARMACEUTICALS LLC
Application ANDA090551
Marketing category ANDA
Marketing start 2016-02-25
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 2019-12-31
Current FDA listing Historical FDA.report record 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 2 · 84 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090551-001 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 A090551-002 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A090551-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090551-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090551-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090551-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090551-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090551-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090551-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090551-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090551-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090551-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090551-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090551-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090551-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090551-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090551-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090551-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090551-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090551-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090551-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090551-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090551-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090551-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090551-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090551-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090551-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090551-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090551-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090551-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090551-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090551-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090551-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090551-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090551-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090551-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090551-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090551-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090551-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090551-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090551-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090551-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 3 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 69150-415-03 2020-01-31 C162847 48780-1 9d75b9d1-012c-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Donepezil Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Donepezil Hydrochloride Tablets, USP. Donepezil Hydrochloride Tablets USP, for oral use Initial U.S. Approval: 1996 69150-415-09 2020-01-31 C162847 48780-1 9d75b9d1-012c-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Donepezil Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Donepezil Hydrochloride Tablets, USP. Donepezil Hydrochloride Tablets USP, for oral use Initial U.S. Approval: 1996 69150-415-10 2020-01-31 C162847 48780-1 9d75b9d1-012c-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Donepezil Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Donepezil Hydrochloride Tablets, USP. Donepezil Hydrochloride Tablets USP, for oral use Initial U.S. Approval: 1996
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69150-415-03 Donepezil Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 4 69150-415-09 Donepezil Hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 4 69150-415-10 Donepezil Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69150-415 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [BIOMES PHARMACEUTICALS LLC] 4 Legacy NDC, 3 package rows 20180516_cb1809d4-5f84-46bc-830a-f71e8c45bc80.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 69150-415-03 69150041503 30 in 1 BOTTLE Historical 69150-415-09 69150041509 90 in 1 BOTTLE Historical 69150-415-10 69150041510 1000 in 1 BOTTLE Historical