DONEPEZIL HYDROCHLORIDE- donepezil hydrochloride tablet, film coated 
Cadila Healthcare 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

Donepezil HCl Tablets, USP

NDC 65841-750-01 in bottle of 100 tablets

Donepezil Hydrochloride Tablets USP, 10 mg

Rx only

100 tablets

Donepezil HCl Tablets, USP
DONEPEZIL HYDROCHLORIDE 
donepezil hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-749
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P) DONEPEZIL HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
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)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code ZF9
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-749-05500 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2011
2NDC:65841-749-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2011
3NDC:65841-749-0630 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2011
4NDC:65841-749-1690 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2011
5NDC:65841-749-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2011
6NDC:65841-749-3010 in 1 CARTON05/25/2011
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09010005/25/2011
DONEPEZIL HYDROCHLORIDE 
donepezil hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-750
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P) DONEPEZIL HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
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)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size9mm
FlavorImprint Code ZF10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-750-0630 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2011
2NDC:65841-750-1690 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2011
3NDC:65841-750-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2011
4NDC:65841-750-05500 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2011
5NDC:65841-750-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2011
6NDC:65841-750-3010 in 1 CARTON05/25/2011
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09010005/25/2011
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(65841-749, 65841-750) , MANUFACTURE(65841-749, 65841-750)

Revised: 8/2020
Document Id: 1034fc7b-c312-437b-89d9-b324b799bc21
Set id: 43a18848-fb43-4adb-9273-a3fe812e3d05
Version: 4
Effective Time: 20200821
 
Cadila Healthcare Limited