Home NDC 42543-703 Donepezil Hydrochloride
Product NDC 42543-703
11-digit product format 425430703
Labeler code 42543
Product ID 42543-703_a73d19f0-cd8e-4b4a-8ded-b9e028305958
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Donepezil Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Vensun Pharmaceuticals, Inc.
Application ANDA203907
Marketing category ANDA
Marketing start 2014-12-10
Marketing end 0000-00-00
Substance DONEPEZIL HYDROCHLORIDE
Active strength 10 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 3 · 126 matching rows.
View current auxiliary records. · View the auxiliary file history.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203907-001 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 A203907-002 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 42543-703-01 These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE tablets, safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE tablets. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996 42543-703-05 These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE tablets, safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE tablets. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996 42543-703-10 These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE tablets, safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE tablets. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996 42543-703-30 These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE tablets, safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE tablets. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996 42543-703-90 These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE tablets, safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE tablets. DONEPEZIL HYDROCHLORIDE tablets, 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 42543-703-01 Donepezil Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 9 42543-703-05 Donepezil Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 9 42543-703-10 Donepezil Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 9 42543-703-30 Donepezil Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 9 42543-703-90 Donepezil Hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DONEPEZIL HYDROCHLORIDE ACTIVE INGREDIENT 3O2T2PJ89D DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.] 3 DONEPEZIL ACTIVE MOIETY 8SSC91326P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.] 3 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.] 3 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42543-703 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.] 9 Legacy NDC, 5 package rows 20180120_851107e7-143c-47f3-8168-1bf197b91c1e.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 42543-703-01 42543070301 100 in 1 BOTTLE Historical 42543-703-05 42543070305 500 in 1 BOTTLE Historical 42543-703-10 42543070310 1000 in 1 BOTTLE Historical 42543-703-30 42543070330 30 in 1 BOTTLE Historical 42543-703-90 42543070390 90 in 1 BOTTLE Historical