Donepezil Hydrochloride

Product NDC
13668-102
11-digit product format
136680102
Labeler code
13668
Product ID
13668-102_bc153659-2091-4682-a63b-8735e1146bac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA090686
Marketing category
ANDA
Marketing start
2011-05-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090686-001DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31
A090686-002DONEPEZIL 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
A090686-001AB
A090686-002AB

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 UTC2026-02A090686-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090686-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090686-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090686-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090686-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090686-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090686-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090686-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090686-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090686-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090686-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090686-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090686-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090686-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090686-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090686-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090686-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090686-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090686-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A090686-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090686-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090686-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090686-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090686-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090686-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090686-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090686-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090686-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090686-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090686-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090686-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090686-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090686-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090686-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090686-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090686-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090686-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090686-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090686-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A090686-002DONEPEZIL 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 UTC2026-02A090686-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090686-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090686-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090686-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090686-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090686-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090686-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090686-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090686-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090686-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090686-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090686-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090686-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090686-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090686-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090686-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090686-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090686-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090686-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090686-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090686-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090686-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090686-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090686-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090686-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090686-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090686-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090686-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090686-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090686-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090686-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090686-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090686-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090686-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090686-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090686-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090686-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090686-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090686-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090686-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Donepezil Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DONEPEZIL HYDROCHLORIDE5 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
76bf638e-dbde-418e-8977-1caf009990bcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94db636e-a074-45fd-8e8d-331920a99436Product name420250103
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7Product name120221214
d7e50b51-94ef-29ef-8273-837d555048c1Product name920160811

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
13668-102-052021-07-14These 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 Rx Only Initial U.S. Approval: 1996
13668-102-102021-07-14These 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 Rx Only Initial U.S. Approval: 1996
13668-102-302021-07-14These 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 Rx Only Initial U.S. Approval: 1996
13668-102-402021-07-14These 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 Rx Only Initial U.S. Approval: 1996
13668-102-742021-07-14These 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 Rx Only Initial U.S. Approval: 1996
13668-102-902021-07-14These 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 Rx Only Initial U.S. Approval: 1996
13668-102-052021-01-29These 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 Rx Only Initial U.S. Approval: 1996
13668-102-102021-01-29These 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 Rx Only Initial U.S. Approval: 1996
13668-102-302021-01-29These 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 Rx Only Initial U.S. Approval: 1996
13668-102-402021-01-29These 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 Rx Only Initial U.S. Approval: 1996
13668-102-742021-01-29These 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 Rx Only Initial U.S. Approval: 1996
13668-102-902021-01-29These 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 Rx Only Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13668-102-05Donepezil Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50016
13668-102-10Donepezil Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100016
13668-102-30Donepezil Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3016
13668-102-40Donepezil Hydrochloride4000 in 1 BOTTLETABLET, FILM COATED400016
13668-102-90Donepezil Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-102-05EA - Each13668-10235f5800e-2b8d-4ae2-81bc-abc17ef1c91b12012-07-24
13668-102-10EA - Each13668-10241148e35-80f9-480b-b06c-9e7cec384dea12012-07-24
13668-102-30EA - Each13668-1021518f73b-7da8-460e-a266-45dd09e80d1c12012-07-24
13668-102-40EA - Each13668-1028ca2af4e-b43e-48e4-baa5-0ff6e6fe34bd12012-07-24
13668-102-74EA - Each13668-102720ca5b5-393a-4688-84de-fbd163abee8d12012-07-24
13668-102-90EA - Each13668-102bc883b5c-59ed-478a-99e1-11086faa59ec12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DONEPEZIL HYDROCHLORIDEACTIVE INGREDIENT3O2T2PJ89DDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED DONEPEZIL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
DONEPEZILACTIVE MOIETY8SSC91326PDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED DONEPEZIL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED DONEPEZIL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED DONEPEZIL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED DONEPEZIL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED DONEPEZIL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED DONEPEZIL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED DONEPEZIL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED DONEPEZIL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED DONEPEZIL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
TALCINACTIVE INGREDIENT7SEV7J4R1UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED DONEPEZIL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED DONEPEZIL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
DONEPEZIL HYDROCHLORIDEACTIVE INGREDIENT3O2T2PJ89DDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]4
DONEPEZILACTIVE MOIETY8SSC91326PDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]4
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]4
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]4
TALCINACTIVE INGREDIENT7SEV7J4R1UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]4
DONEPEZIL HYDROCHLORIDEACTIVE INGREDIENT3O2T2PJ89DDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
DONEPEZILACTIVE MOIETY8SSC91326PDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-102DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]15Current NDC, Legacy NDC, 5 package rows20250122_76bf638e-dbde-418e-8977-1caf009990bc.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDECardinal Health 107, LLCc942a4c9-dbe5-4131-bb6c-aa2d31b387e72026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090686
application number: ANDA090686
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEMajor Pharmaceuticalsc777ddc9-0b61-4d6f-95d6-818ba1861d622026-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090686
application number: ANDA090686
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDETorrent Pharmaceuticals Limited76bf638e-dbde-418e-8977-1caf009990bc2026-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090686
application number: ANDA090686
ndc (product): 13668-102

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN76bf638e-dbde-418e-8977-1caf009990bc16
997229donepezil HCl 5 MG Oral TabletPSN76bf638e-dbde-418e-8977-1caf009990bc16
997223donepezil hydrochloride 10 MG Oral TabletSCD76bf638e-dbde-418e-8977-1caf009990bc16
997229donepezil hydrochloride 5 MG Oral TabletSCD76bf638e-dbde-418e-8977-1caf009990bc16
997223donepezil HCl 10 MG Oral TabletPSNc777ddc9-0b61-4d6f-95d6-818ba1861d626
997229donepezil HCl 5 MG Oral TabletPSNc777ddc9-0b61-4d6f-95d6-818ba1861d626
997223donepezil hydrochloride 10 MG Oral TabletSCDc777ddc9-0b61-4d6f-95d6-818ba1861d626
997229donepezil hydrochloride 5 MG Oral TabletSCDc777ddc9-0b61-4d6f-95d6-818ba1861d626
997223donepezil HCl 10 MG Oral TabletPSNec5cc9e9-aa3a-4c54-b0a1-de1449701f781
997229donepezil HCl 5 MG Oral TabletPSNec5cc9e9-aa3a-4c54-b0a1-de1449701f781
997223donepezil hydrochloride 10 MG Oral TabletSCDec5cc9e9-aa3a-4c54-b0a1-de1449701f781
997229donepezil hydrochloride 5 MG Oral TabletSCDec5cc9e9-aa3a-4c54-b0a1-de1449701f781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13668-102-0513668010205500 TABLET, FILM COATED in 1 BOTTLE (13668-102-05) 2011-05-310000-00-00NoNoCurrent
13668-102-10136680102101000 TABLET, FILM COATED in 1 BOTTLE (13668-102-10) 2011-05-310000-00-00NoNoCurrent
13668-102-301366801023030 TABLET, FILM COATED in 1 BOTTLE (13668-102-30) 2011-05-310000-00-00NoNoCurrent
13668-102-40136680102404000 TABLET, FILM COATED in 1 BOTTLE (13668-102-40) 2011-05-310000-00-00NoNoCurrent
13668-102-7413668010274100 TABLET, FILM COATED in 1 CARTON (13668-102-74) 2011-05-310000-00-00NoNoCurrent
13668-102-901366801029090 TABLET, FILM COATED in 1 BOTTLE (13668-102-90) 2011-05-310000-00-00NoNoCurrent