Home NDC 50228-139 Donepezil Hydrochloride
Product NDC 50228-139
11-digit product format 502280139
Labeler code 50228
Product ID 50228-139_652d4a32-9c92-43df-be8a-a91cfaf61c3a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Donepezil Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ScieGen Pharmaceuticals, Inc.
Application ANDA203907
Marketing category ANDA
Marketing start 2014-10-29
Substance DONEPEZIL HYDROCHLORIDE
Active strength 5 mg/1
Pharmacologic classes Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 A203907-001 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 A203907-002 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29
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 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203907-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-10-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203907-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-10-29 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Donepezil Hydrochloride
Listing expiration 2027-12-31 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 50228-139-10 Donepezil Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 6 50228-139-30 Donepezil Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 6
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 [SCIEGEN PHARMACEUTICALS, INC.] 4 DONEPEZIL ACTIVE MOIETY 8SSC91326P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] 4 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] 4 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] 4 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] 4 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] 4 DONEPEZIL HYDROCHLORIDE ACTIVE INGREDIENT 3O2T2PJ89D DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC] 1 DONEPEZIL ACTIVE MOIETY 8SSC91326P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC] 1 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC] 1 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50228-139 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20190330_6e9aacf9-abb6-4dec-9a8d-4eabf934d512.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 · 2 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 50228-139-10 50228013910 1000 TABLET, FILM COATED in 1 BOTTLE (50228-139-10) 2014-10-29 0000-00-00 No No Current 50228-139-30 50228013930 30 TABLET, FILM COATED in 1 BOTTLE (50228-139-30) 2014-10-29 0000-00-00 No No Current