DIPYRIDAMOLE- dipyridamole tablet, film coated 
Zydus Lifesciences Limited

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Dipyridamole Tablets, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-662-01 in bottle of 100 tablets

Dipyridamole Tablets USP, 25 mg

Rx only

100 tablets

ZYDUS

Dipyridamole Tablets, 25 mg

NDC 65841-663-01 in bottle of 100 tablets

Dipyridamole Tablets USP, 50 mg

Rx only

100 tablets

ZYDUS

Dipyridamole Tablets, 50 mg

NDC 65841-664-01 in bottle of 100 tablets

Dipyridamole Tablets USP, 75 mg

Rx only

100 tablets

ZYDUS

Dipyridamole Tablets, 75 mg
DIPYRIDAMOLE 
dipyridamole tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-662
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C) DIPYRIDAMOLE25 mg
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorYELLOW (LIGHT YELLOW) Scoreno score
ShapeROUND (ROUND) Size6mm
FlavorImprint Code ZE;43
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-662-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/22/2008
2NDC:65841-662-05500 in 1 BOTTLE; Type 0: Not a Combination Product05/22/2008
3NDC:65841-662-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/22/2008
4NDC:65841-662-7710 in 1 CARTON05/22/2008
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04087405/22/2008
DIPYRIDAMOLE 
dipyridamole tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-663
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C) DIPYRIDAMOLE50 mg
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorYELLOW (LIGHT YELLOW) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code ZE;49
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-663-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/22/2008
2NDC:65841-663-05500 in 1 BOTTLE; Type 0: Not a Combination Product05/22/2008
3NDC:65841-663-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/22/2008
4NDC:65841-663-7710 in 1 CARTON05/22/2008
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04087405/22/2008
DIPYRIDAMOLE 
dipyridamole tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-664
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C) DIPYRIDAMOLE75 mg
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorYELLOW (LIGHT YELLOW) Scoreno score
ShapeROUND (ROUND) Size8mm
FlavorImprint Code ZE;50
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-664-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/22/2008
2NDC:65841-664-05500 in 1 BOTTLE; Type 0: Not a Combination Product05/22/2008
3NDC:65841-664-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/22/2008
4NDC:65841-664-7710 in 1 CARTON05/22/2008
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04087405/22/2008
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-662, 65841-663, 65841-664) , MANUFACTURE(65841-662, 65841-663, 65841-664)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited677605858ANALYSIS(65841-662, 65841-663, 65841-664) , MANUFACTURE(65841-662, 65841-663, 65841-664)

Revised: 11/2024
Document Id: 7426aa35-2cba-4a73-b80f-d044bfe22177
Set id: 312aadb1-435c-4aa7-8e46-6506cedacaa0
Version: 8
Effective Time: 20241126
 
Zydus Lifesciences Limited