Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg
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 useInitial U.S. Approval: 1999
Approved
Approval ID
237a1f63-53ff-47fa-903c-ac6276e594a2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2022
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Aspirin and Extended - Release Dipyridamole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-007
Application NumberANDA207944
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aspirin and Extended - Release Dipyridamole
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2018
FDA Product Classification
INGREDIENTS (27)
ASPIRINActive
Quantity: 25 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
DIPYRIDAMOLEActive
Quantity: 200 mg in 1 1
Code: 64ALC7F90C
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT