ASPIRIN-DIPYRIDAMOLE - aspirin-dipyridamole capsule 
Zydus Lifesciences Limited

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ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE CAPSULES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1172-6

Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg

Rx only

60 Capsules

Aspirin and Extended-release Dipyridamole Capsules
ASPIRIN-DIPYRIDAMOLE 
aspirin-dipyridamole capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1172
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN25 mg
DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C) DIPYRIDAMOLE200 mg
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
AMMONIA (UNII: 5138Q19F1X)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) (UNII: G4U024CQK6)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) (UNII: 5KY68S2577)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorRED (OPAQUE RED CAP) , WHITE (OPAQUE WHITE BODY) Scoreno score
ShapeCAPSULE (CAPSULE) Size24mm
FlavorImprint Code 618
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1172-660 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20675301/04/2018
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1172) , MANUFACTURE(70771-1172)

Revised: 10/2022
Document Id: 76d666a7-044a-49c0-ada8-1a0ee22d3dbc
Set id: 72f3a5f5-562d-4fbf-bac2-5123f873699d
Version: 5
Effective Time: 20221013
 
Zydus Lifesciences Limited