Home NDC 63304-128 Donepezil Hydrochloride
Product NDC 63304-128
11-digit product format 633040128
Labeler code 63304
Product ID 63304-128_e045a98a-fd37-48c0-ba67-2889a4666d8c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Donepezil Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Ranbaxy Pharmaceuticals Inc.
Application ANDA076786
Marketing category ANDA
Marketing start 2010-11-29
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 3 · 154 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 A076786-001 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2010-11-26 A076786-002 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2010-11-26
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 A076786-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2010-11-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076786-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2010-11-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076786-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2010-11-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076786-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2010-11-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076786-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2010-11-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076786-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2010-11-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076786-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2010-11-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076786-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2010-11-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076786-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2010-11-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076786-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2010-11-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076786-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2010-11-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076786-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2010-11-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076786-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2010-11-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076786-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2010-11-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076786-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2010-11-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076786-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2010-11-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076786-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2010-11-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076786-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2010-11-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076786-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2010-11-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076786-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2010-11-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076786-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2010-11-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076786-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2010-11-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076786-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2010-11-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076786-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2010-11-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076786-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2010-11-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076786-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2010-11-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076786-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2010-11-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076786-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2010-11-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076786-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2010-11-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076786-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2010-11-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076786-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2010-11-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076786-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2010-11-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076786-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2010-11-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076786-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2010-11-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076786-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2010-11-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076786-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2010-11-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076786-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2010-11-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076786-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2010-11-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076786-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2010-11-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076786-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2010-11-26 74a2ff9319b5…
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, Related label table NDC Related label 63304-128-10 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 63304-128-20 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 63304-128-30 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 63304-128-31 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 63304-128-77 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 63304-128-90 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 63304-128-10 Donepezil Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 7 63304-128-20 Donepezil Hydrochloride 20 in 1 BOTTLE TABLET, FILM COATED 20 7 63304-128-30 Donepezil Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 7 63304-128-31 Donepezil Hydrochloride 10 in 1 BLISTER PACK TABLET, FILM COATED 10 7 63304-128-31 Donepezil Hydrochloride 3 in 1 CARTON TABLET, FILM COATED 3 7 63304-128-77 Donepezil Hydrochloride 10 in 1 BLISTER PACK TABLET, FILM COATED 10 7 63304-128-77 Donepezil Hydrochloride 10 in 1 CARTON TABLET, FILM COATED 10 7 63304-128-90 Donepezil Hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 7
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 [RANBAXY PHARMACEUTICALS INC.] 7 DONEPEZIL ACTIVE MOIETY 8SSC91326P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 7 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 7 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 7 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 7 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 7 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 7 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 7 TALC INACTIVE INGREDIENT 7SEV7J4R1U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 7 DONEPEZIL HYDROCHLORIDE ACTIVE INGREDIENT 3O2T2PJ89D DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 DONEPEZIL ACTIVE MOIETY 8SSC91326P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63304-128 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 7 Legacy NDC, 8 package rows 20131219_4fbb6318-f83f-47ce-ab6c-09e92460bb6d.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 63304-128-10 63304012810 1000 in 1 BOTTLE Historical 63304-128-20 63304012820 20 in 1 BOTTLE Historical 63304-128-30 63304012830 30 in 1 BOTTLE Historical 63304-128-31 63304012831 10 in 1 BLISTER PACK Historical 63304-128-77 63304012877 10 in 1 BLISTER PACK Historical 63304-128-90 63304012890 90 in 1 BOTTLE Historical