Home NDC 68382-303 donepezil hydrochloride
Product NDC 68382-303
11-digit product format 683820303
Labeler code 68382
Product ID 68382-303_b0572ed8-c991-403f-a8e9-af8be1ce39dc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name donepezil hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals (USA) Inc.
Application ANDA090100
Marketing category ANDA
Marketing start 2011-05-25
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 2021-12-31
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 A090100-001 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-10-24 A090100-002 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24
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 A090100-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-10-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090100-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090100-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-10-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090100-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090100-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-10-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090100-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090100-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-10-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090100-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090100-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-10-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090100-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090100-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-10-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090100-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090100-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-10-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090100-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090100-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-10-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090100-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090100-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-10-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090100-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090100-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-10-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090100-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090100-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-10-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090100-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090100-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-10-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090100-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090100-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-10-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090100-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090100-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-10-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090100-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090100-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-10-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090100-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090100-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-10-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090100-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090100-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-10-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090100-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090100-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-10-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090100-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090100-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-10-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090100-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090100-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-10-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090100-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 [ZYDUS PHARMACEUTICALS (USA) INC.] 4 DONEPEZIL ACTIVE MOIETY 8SSC91326P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 4 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 4
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68382-303-01 68382030301 100 TABLET, FILM COATED in 1 BOTTLE (68382-303-01) 2011-05-25 0000-00-00 No No Current 68382-303-05 68382030305 500 TABLET, FILM COATED in 1 BOTTLE (68382-303-05) 2011-05-25 0000-00-00 No No Current 68382-303-06 68382030306 30 TABLET, FILM COATED in 1 BOTTLE (68382-303-06) 2011-05-25 0000-00-00 No No Current 68382-303-10 68382030310 1000 TABLET, FILM COATED in 1 BOTTLE (68382-303-10) 2011-05-25 0000-00-00 No No Current 68382-303-16 68382030316 90 TABLET, FILM COATED in 1 BOTTLE (68382-303-16) 2011-05-25 0000-00-00 No No Current 68382-303-77 68382030377 100 BLISTER PACK in 1 CARTON (68382-303-77) > 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-303-30) 100 blister pack 2011-05-25 0000-00-00 No No Current