DONEPEZIL HYDROCHLORIDE- donepezil hydrochloride tablet, film coated
Zydus Lifesciences Limited

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DONEPEZIL HYDROCHLORIDE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-749-01 in bottle of 100 tablets

Donepezil Hydrochloride Tablets USP, 5 mg

Rx only

100 tablets

NDC 65841-750-01 in bottle of 100 tablets

Donepezil Hydrochloride Tablets USP, 10 mg

Rx only

100 tablets

DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride tablet, film coated

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P)	DONEPEZIL HYDROCHLORIDE	5 mg

Ingredient Name	Strength
Inactive Ingredients
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-749-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	05/25/2011	03/25/2025
2	NDC:65841-749-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	05/25/2011	03/25/2025
3	NDC:65841-749-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	05/25/2011	03/25/2025
4	NDC:65841-749-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	05/25/2011	03/25/2025
5	NDC:65841-749-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/25/2011	03/25/2025
6	NDC:65841-749-30	10 in 1 CARTON	05/25/2011	03/25/2025
6		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090100	05/25/2011	08/14/2025

DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride tablet, film coated

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P)	DONEPEZIL HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-750-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	05/25/2011	03/25/2025
2	NDC:65841-750-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	05/25/2011	03/25/2025
3	NDC:65841-750-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/25/2011	03/25/2025
4	NDC:65841-750-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	05/25/2011	03/25/2025
5	NDC:65841-750-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	05/25/2011	03/25/2025
6	NDC:65841-750-30	10 in 1 CARTON	05/25/2011	03/25/2025
6		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090100	05/25/2011	08/14/2025

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(65841-749, 65841-750) , MANUFACTURE(65841-749, 65841-750)

Revised: 8/2025

Document Id: 90bef7f3-6bf0-4679-8dae-b533bbec6eb0

Set id: 43a18848-fb43-4adb-9273-a3fe812e3d05

Version: 6

Effective Time: 20250814

Zydus Lifesciences Limited