Home NDC 24724-028 DONEPEZIL HYDROCHLORIDE
Product NDC 24724-028
11-digit product format 247240028
Labeler code 24724
Product ID 24724-028_9e4deae4-c73a-4d5f-94bf-a7ca02a813ad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DONEPEZIL
Dosage form TABLET, FILM COATED
Route ORAL
Labeler INDICUS PHARMA LLC
Application ANDA201634
Marketing category ANDA
Marketing start 2011-06-15
Marketing end 0000-00-00
Substance DONEPEZIL HYDROCHLORIDE
Active strength 5 mg/1
Pharmacologic classes Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2018-12-31
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 · 88 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 24724-028-10 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 24724-028-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 24724-028-03 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 24724-028-03 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 24724-028-01 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 24724-028-10 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 24724-028-03 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 24724-028-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 24724-028-10 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 24724-028-03 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 24724-028-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 24724-028-10 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 24724-028-03 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 24724-028-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 24724-028-10 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 24724-028-03 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 24724-028-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 24724-028-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 24724-028-03 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 24724-028-01 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 24724-028-10 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 24724-028-03 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 24724-028-01 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 24724-028-10 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 24724-028-03 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 24724-028-01 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 24724-028-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 24724-028-03 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 24724-028-01 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 24724-028-10 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 24724-028-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 24724-028-01 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 24724-028-10 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 24724-028-03 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 24724-028-01 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 24724-028-10 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 24724-028-03 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 24724-028-01 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 24724-028-10 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 24724-028-03 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 24724-028-01 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 24724-028-10 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 24724-028-03 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 24724-028-01 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 24724-028-10 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
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 A201634-001 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2012-06-13 A201634-002 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2012-06-13
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 A201634-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2012-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201634-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2012-06-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201634-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2012-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201634-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2012-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201634-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2012-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201634-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2012-06-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201634-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201634-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-06-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201634-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201634-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-06-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201634-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-06-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201634-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-06-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201634-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-06-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201634-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-06-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201634-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-06-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201634-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-06-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201634-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-06-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201634-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-06-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201634-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-06-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201634-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-06-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201634-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-06-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201634-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-06-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201634-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-06-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201634-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-06-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201634-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-06-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201634-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-06-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201634-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-06-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201634-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-06-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201634-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-06-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201634-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-06-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201634-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-06-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201634-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-06-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201634-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-06-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201634-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-06-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201634-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-06-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A201634-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-06-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201634-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-06-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A201634-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-06-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201634-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-06-13 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A201634-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-06-13 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DONEPEZIL HYDROCHLORIDE ACTIVE INGREDIENT 3O2T2PJ89D DONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC] 5 DONEPEZIL ACTIVE MOIETY 8SSC91326P DONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC] 5 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 DONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC] 5 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 DONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC] 5 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W DONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC] 5 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC] 5 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ DONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC] 5 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B DONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC] 5 TALC INACTIVE INGREDIENT 7SEV7J4R1U DONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24724-028 DONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC] 5 Legacy NDC 20110707_e8ac5d36-8116-456f-8274-3defac54bb24.zip