Home NDC 71209-019 DONEPEZIL HYDROCHLORIDE
Product NDC 71209-019
11-digit product format 712090019
Labeler code 71209
Product ID 71209-019_e33aac76-604d-43cb-8be4-d58ce3b2b6f8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name donepezil hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cadila Pharmaceuticals Limited
Application ANDA204609
Marketing category ANDA
Marketing start 2017-01-30
Substance DONEPEZIL HYDROCHLORIDE
Active strength 5 mg/1
Pharmacologic classes Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A204609-001 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-09-19 A204609-002 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-09-19
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 · 84 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 2026-08-18 06:07:40 2026-07 A204609-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-09-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204609-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-09-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204609-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-09-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204609-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-09-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204609-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-09-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204609-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-09-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204609-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-09-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204609-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-09-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204609-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-09-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204609-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-09-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204609-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-09-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204609-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-09-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204609-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-09-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204609-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-09-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204609-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-09-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204609-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-09-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204609-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-09-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204609-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-09-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204609-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-09-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204609-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-09-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204609-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-09-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204609-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-09-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204609-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-09-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204609-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-09-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204609-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-09-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204609-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-09-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204609-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-09-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204609-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-09-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204609-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-09-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204609-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-09-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204609-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-09-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204609-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-09-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204609-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-09-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204609-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-09-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204609-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-09-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204609-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-09-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204609-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-09-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204609-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-09-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204609-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-09-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204609-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-09-19 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base DONEPEZIL HYDROCHLORIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DONEPEZIL HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3O2T2PJ89D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 997223 Internal RxNorm lookup 997229 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71209-019-01 DONEPEZIL HYDROCHLORIDE 30 in 1 BOTTLE TABLET, FILM COATED 30 7 71209-019-04 DONEPEZIL HYDROCHLORIDE 90 in 1 BOTTLE TABLET, FILM COATED 90 7 71209-019-11 DONEPEZIL HYDROCHLORIDE 1000 in 1 BOTTLE TABLET, FILM COATED 1000 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71209-019 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CADILA PHARMACEUTICALS LIMITED] 7 Current NDC, Legacy NDC, 3 package rows 20221228_37aa1285-774a-4714-a4af-4e3fa9fa7f55.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71209-019-01 71209001901 30 TABLET, FILM COATED in 1 BOTTLE (71209-019-01) 2018-11-24 0000-00-00 No No Current 71209-019-04 71209001904 90 TABLET, FILM COATED in 1 BOTTLE (71209-019-04) 2018-11-24 0000-00-00 No No Current 71209-019-11 71209001911 1000 TABLET, FILM COATED in 1 BOTTLE (71209-019-11) 2018-11-24 0000-00-00 No No Current