aspirin-dipyridamole
ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE CAPSULES
Approved
Approval ID
72f3a5f5-562d-4fbf-bac2-5123f873699d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 13, 2022
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
aspirin-dipyridamole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1172
Application NumberANDA206753
Product Classification
M
Marketing Category
C73584
G
Generic Name
aspirin-dipyridamole
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2022
FDA Product Classification
INGREDIENTS (28)
DIPYRIDAMOLEActive
Quantity: 200 mg in 1 1
Code: 64ALC7F90C
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)Inactive
Code: G4U024CQK6
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ASPIRINActive
Quantity: 25 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive
Code: 5KY68S2577
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 8/13/2020
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1172-6
Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg
Rx only
60 Capsules
