ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE
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 Initial U.S. Approval: 1999
Approved
Approval ID
111a4f6a-c3e4-43e2-8f0e-8c72f71cddb2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 28, 2022
Manufacturers
FDA
Micro Labs Limited
DUNS: 862174955
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 Code42571-274
Application NumberANDA209929
Product Classification
M
Marketing Category
C73584
G
Generic Name
ASPIRIN and Extended-Release DIPYRIDAMOLE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 28, 2022
FDA Product Classification
INGREDIENTS (26)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ASPIRINActive
Quantity: 25 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
DIPYRIDAMOLEActive
Quantity: 200 mg in 1 1
Code: 64ALC7F90C
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CAPRYLIC/CAPRIC MONO/DIGLYCERIDESInactive
Code: U72Q2I8C85
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT