Donepezil Hydrochloride

Product NDC
16571-779
11-digit product format
165710779
Labeler code
16571
Product ID
16571-779_b963d4b7-66f3-47d7-8671-7412d49e6cb3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA090056
Marketing category
ANDA
Marketing start
2011-05-31
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
10 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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090056-001DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31
A090056-002DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A090056-001AB
A090056-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090056-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090056-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090056-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090056-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090056-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090056-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090056-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090056-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090056-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090056-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090056-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090056-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090056-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090056-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090056-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090056-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090056-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090056-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090056-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A090056-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090056-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090056-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090056-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090056-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090056-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090056-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090056-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090056-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090056-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090056-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090056-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090056-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090056-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090056-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090056-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090056-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090056-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090056-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090056-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A090056-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090056-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090056-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090056-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090056-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090056-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090056-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090056-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090056-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090056-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090056-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090056-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090056-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090056-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090056-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090056-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090056-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090056-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090056-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090056-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090056-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090056-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090056-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090056-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090056-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090056-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090056-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090056-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090056-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090056-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090056-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090056-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090056-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090056-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090056-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090056-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090056-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090056-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090056-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090056-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090056-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Donepezil Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DONEPEZIL HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3O2T2PJ89DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
997223Internal RxNorm lookup
997229Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
86b0c5a0-ff3c-4840-a4ac-82af922d58bfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94db636e-a074-45fd-8e8d-331920a99436Product name420250103
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7Product name120221214
d7e50b51-94ef-29ef-8273-837d555048c1Product name920160811

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-779-03Donepezil Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
16571-779-09Donepezil Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902
16571-779-10Donepezil Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10002
16571-779-50Donepezil Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-779-03EA - Each16571-7794f1b54a3-169a-4017-8878-e82b6c0bc36e12021-11-09
16571-779-09EA - Each16571-7797938814b-088b-428c-a6d9-cc35229f120912021-11-09
16571-779-10EA - Each16571-7795078d7c2-55c0-4036-a854-bffba21af50312021-11-09
16571-779-50EA - Each16571-77998e6de95-f5c0-4553-a535-fd5c3862f8c112021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-779DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]2Current NDC, Legacy NDC, 4 package rows20240110_86b0c5a0-ff3c-4840-a4ac-82af922d58bf.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEPreferred Pharmaceuticals Inc.8138f616-83f3-4c47-84ef-1bce2db339f72026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090056
application number: ANDA090056
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEREMEDYREPACK INC.de96349a-5fee-4de9-921c-e453d44b32032025-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090056
application number: ANDA090056
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEBryant Ranch Prepacke2ab403a-ec2d-44e7-9da1-66d0a7443f1d2025-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090056
application number: ANDA090056
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDECoupler LLC2d01fb96-c825-fad5-e063-6394a90ac6cc2025-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090056
application number: ANDA090056
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEA-S Medication Solutions0516d548-db9b-410a-aec9-79aedbc3f6e92024-10-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090056
application number: ANDA090056
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEBryant Ranch Prepackc030fd7c-da5c-457a-a825-1767bd87d04d2024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090056
application number: ANDA090056
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEBryant Ranch Prepack1c6e8d7f-5219-4b6c-a1ce-2baff28c3d552024-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090056
application number: ANDA090056
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEAurobindo Pharma Limited3257494f-8f44-4978-b92d-bde87b2444b62024-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090056
application number: ANDA090056
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDERising Pharma Holdings, Inc.86b0c5a0-ff3c-4840-a4ac-82af922d58bf2024-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090056
application number: ANDA090056
ndc (product): 16571-779

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN1c6e8d7f-5219-4b6c-a1ce-2baff28c3d55100
997223donepezil hydrochloride 10 MG Oral TabletSCD1c6e8d7f-5219-4b6c-a1ce-2baff28c3d55100
997223donepezil HCl 10 MG Oral TabletPSN86b0c5a0-ff3c-4840-a4ac-82af922d58bf2
997229donepezil HCl 5 MG Oral TabletPSN86b0c5a0-ff3c-4840-a4ac-82af922d58bf2
997223donepezil hydrochloride 10 MG Oral TabletSCD86b0c5a0-ff3c-4840-a4ac-82af922d58bf2
997229donepezil hydrochloride 5 MG Oral TabletSCD86b0c5a0-ff3c-4840-a4ac-82af922d58bf2
997223donepezil HCl 10 MG Oral TabletPSN27be405c-83bf-5ccf-e063-6394a90adc4a1
997223donepezil hydrochloride 10 MG Oral TabletSCD27be405c-83bf-5ccf-e063-6394a90adc4a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16571-779-031657107790330 TABLET, FILM COATED in 1 BOTTLE (16571-779-03) 2011-05-310000-00-00NoNoCurrent
16571-779-091657107790990 TABLET, FILM COATED in 1 BOTTLE (16571-779-09) 2011-05-310000-00-00NoNoCurrent
16571-779-10165710779101000 TABLET, FILM COATED in 1 BOTTLE (16571-779-10) 2011-05-310000-00-00NoNoCurrent
16571-779-5016571077950500 TABLET, FILM COATED in 1 BOTTLE (16571-779-50) 2011-05-310000-00-00NoNoCurrent