Aspirin and Dipyridamole Extended Release
These highlights do not include all the information needed to use ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE CAPSULES safely and effectively. See full prescribing information for ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE CAPSULES. ASPIRIN and extended-release DIPYRIDAMOLE capsules, for oral use only Initial U.S. Approval: 1999
Approved
Approval ID
e85a2ba8-9d8a-4921-8a6d-5c04a0604926
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2019
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Aspirin and Dipyridamole Extended Release
PRODUCT DETAILS
NDC Product Code47335-927
Application NumberANDA208572
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 18, 2019
Generic NameAspirin and Dipyridamole Extended Release
INGREDIENTS (29)
ASPIRINActive
Quantity: 25 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
DIPYRIDAMOLEActive
Quantity: 200 mg in 1 1
Code: 64ALC7F90C
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive
Code: 5KY68S2577
Classification: IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)Inactive
Code: G4U024CQK6
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT