Home NDC 59746-330 DONEPEZIL HYDROCHLORIDE
Product NDC 59746-330
11-digit product format 597460330
Labeler code 59746
Product ID 59746-330_8a92fbfc-6c69-4af8-84d3-ef4bfbae6b32
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DONEPEZIL HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Jubilant Cadista Pharmaceuticals Inc.
Application ANDA090768
Marketing category ANDA
Marketing start 2011-05-31
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 2020-12-31
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 · 105 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 A090768-001 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 A090768-002 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 · 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 A090768-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090768-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090768-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090768-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090768-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090768-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090768-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090768-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090768-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090768-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090768-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090768-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090768-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090768-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090768-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090768-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090768-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090768-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090768-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090768-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090768-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090768-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090768-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090768-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090768-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090768-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090768-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090768-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090768-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090768-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090768-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090768-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090768-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090768-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090768-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090768-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090768-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090768-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090768-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A090768-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 59746-330-01 2025-12-31 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 59746-330-03 2025-12-31 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 59746-330-05 2025-12-31 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 59746-330-10 2025-12-31 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 59746-330-30 2025-12-31 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 59746-330-90 2025-12-31 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 59746-330-01 2023-01-30 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 59746-330-03 2023-01-30 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 59746-330-05 2023-01-30 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 59746-330-10 2023-01-30 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 59746-330-30 2023-01-30 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 59746-330-90 2023-01-30 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
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 [JUBILANT CADISTA PHARMACEUTICALS INC.] 4 Donepezil ACTIVE MOIETY 8SSC91326P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 4 Cellulose, Microcrystalline INACTIVE INGREDIENT OP1R32D61U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 4 Hydroxypropyl Cellulose, Low Substituted INACTIVE INGREDIENT 2165RE0K14 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 4 Hypromellose 2910 (6 Mpa.s) INACTIVE INGREDIENT 0WZ8WG20P6 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 4 Lactose Monohydrate INACTIVE INGREDIENT EWQ57Q8I5X DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 4 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 4 Polyethylene Glycol 8000 INACTIVE INGREDIENT Q662QK8M3B DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 4 Starch, Corn INACTIVE INGREDIENT O8232NY3SJ DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 4 Talc INACTIVE INGREDIENT 7SEV7J4R1U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 4 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 4 Donepezil Hydrochloride ACTIVE INGREDIENT 3O2T2PJ89D DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 1 Donepezil ACTIVE MOIETY 8SSC91326P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 1 Cellulose, Microcrystalline INACTIVE INGREDIENT OP1R32D61U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 1 Hydroxypropyl Cellulose, Low Substituted INACTIVE INGREDIENT 2165RE0K14 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 1 Hypromellose 2910 (6 Mpa.s) INACTIVE INGREDIENT 0WZ8WG20P6 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 1 Lactose Monohydrate INACTIVE INGREDIENT EWQ57Q8I5X DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 1 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 1 Polyethylene Glycol 8000 INACTIVE INGREDIENT Q662QK8M3B DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 1 Starch, Corn INACTIVE INGREDIENT O8232NY3SJ DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 1 Talc INACTIVE INGREDIENT 7SEV7J4R1U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 1 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59746-330 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 7 Legacy NDC 20190904_0baef0fd-e6c0-4ee8-bb7e-1d2e89d6e0ec.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59746-330-01 59746033001 100 TABLET, FILM COATED in 1 BOTTLE (59746-330-01) 2011-05-31 0000-00-00 No No Current 59746-330-03 59746033003 10 BLISTER PACK in 1 CARTON (59746-330-03) > 10 TABLET, FILM COATED in 1 BLISTER PACK (59746-330-12) 10 blister pack 2011-05-31 0000-00-00 No No Current 59746-330-05 59746033005 500 TABLET, FILM COATED in 1 BOTTLE (59746-330-05) 2011-05-31 0000-00-00 No No Current 59746-330-10 59746033010 1000 TABLET, FILM COATED in 1 BOTTLE (59746-330-10) 2011-05-31 0000-00-00 No No Current 59746-330-30 59746033030 30 TABLET, FILM COATED in 1 BOTTLE (59746-330-30) 2011-05-31 0000-00-00 No No Current 59746-330-90 59746033090 90 TABLET, FILM COATED in 1 BOTTLE (59746-330-90) 2011-05-31 0000-00-00 No No Current