DONEPEZIL HYDROCHLORIDE- donepezil hydrochloride tablet, orally disintegrating 
Cadila Healthcare Limited

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DONEPEZIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-721-06 in bottle of 30 tablets

Donepezil Hydrochloride Orally Disintegrating Tablets USP, 5 mg

Rx only

30 tablets

Donepezil Hydrochloride Orally Disintegrating Tablets, 5 mg

NDC 65841-722-06 in bottle of 30 tablets

Donepezil Hydrochloride Orally Disintegrating Tablets USP, 10 mg

Rx only

30 tablets

Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg
DONEPEZIL HYDROCHLORIDE 
donepezil hydrochloride tablet, orally disintegrating
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-721
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
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
PEPPERMINT (UNII: V95R5KMY2B)  
STRAWBERRY (UNII: 4J2TY8Y81V)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorWHITE (WHITE TO OFF WHITE) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorPEPPERMINT (flavor firmenich powder peppermint) , STRAWBERRY (flavor strawberry) Imprint Code ZF;14
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-721-0630 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2011
2NDC:65841-721-1690 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2011
3NDC:65841-721-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2011
4NDC:65841-721-05500 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2011
5NDC:65841-721-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2011
6NDC:65841-721-3010 in 1 CARTON05/11/2011
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09017505/11/2011
DONEPEZIL HYDROCHLORIDE 
donepezil hydrochloride tablet, orally disintegrating
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-722
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
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
PEPPERMINT (UNII: V95R5KMY2B)  
STRAWBERRY (UNII: 4J2TY8Y81V)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorWHITE (WHITE TO OFF WHITE) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorPEPPERMINT (flavor firmenich powder peppermint) , STRAWBERRY (flavor strawberry) Imprint Code ZF;15
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-722-0630 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2011
2NDC:65841-722-1690 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2011
3NDC:65841-722-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2011
4NDC:65841-722-05500 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2011
5NDC:65841-722-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2011
6NDC:65841-722-3010 in 1 CARTON05/11/2011
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09017505/11/2011
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(65841-721, 65841-722) , MANUFACTURE(65841-721, 65841-722)

Revised: 8/2020
Document Id: 7e7d6dc6-401f-44e4-8ff6-b39efe831a39
Set id: adb67d38-99f4-44ea-b2c2-b472be7bafc7
Version: 5
Effective Time: 20200821
 
Cadila Healthcare Limited