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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code47335-927
Application NumberANDA208572
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aspirin and Dipyridamole Extended Release
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 18, 2019
FDA Product Classification
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