Dipyridamole
Dipyridamole Tablets, USP (25 mg, 50 mg and 75 mg)Rx only
Approved
Approval ID
a18b2af5-7c4a-4b7f-92c7-8a76e34da373
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 17, 2023
Manufacturers
FDA
Amneal Pharmaceuticals of New York LLC
DUNS: 123797875
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DIPYRIDAMOLE
PRODUCT DETAILS
NDC Product Code0115-1072
Application NumberANDA040782
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 17, 2023
Generic NameDIPYRIDAMOLE
INGREDIENTS (11)
DIPYRIDAMOLEActive
Quantity: 75 mg in 1 1
Code: 64ALC7F90C
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
DIPYRIDAMOLE
PRODUCT DETAILS
NDC Product Code0115-1070
Application NumberANDA040782
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 17, 2023
Generic NameDIPYRIDAMOLE
INGREDIENTS (11)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DIPYRIDAMOLEActive
Quantity: 25 mg in 1 1
Code: 64ALC7F90C
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
DIPYRIDAMOLE
PRODUCT DETAILS
NDC Product Code0115-1071
Application NumberANDA040782
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 17, 2023
Generic NameDIPYRIDAMOLE
INGREDIENTS (11)
DIPYRIDAMOLEActive
Quantity: 50 mg in 1 1
Code: 64ALC7F90C
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Drug Labeling Information
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 4/17/2023
DOSAGE AND ADMINISTRATION
Adjunctive Use in Prophylaxis of Thromboembolism after Cardiac Valve Replacement.
The recommended dose is 75 mg to 100 mg four times daily as an adjunct to the usual warfarin therapy. Please note that aspirin is not to be administered concomitantly with coumarin anticoagulants.