DIPYRIDAMOLE
Dipyridamole Tablets
Approved
Approval ID
0146650f-d6e6-4a9c-8925-415b3c92b0e7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2022
Manufacturers
FDA
Rising Pharmaceuticals, Inc.
DUNS: 041241766
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DIPYRIDAMOLE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64980-135
Application NumberANDA040733
Product Classification
M
Marketing Category
C73584
G
Generic Name
DIPYRIDAMOLE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2022
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
DIPYRIDAMOLEActive
Quantity: 75 mg in 1 1
Code: 64ALC7F90C
Classification: ACTIB
DIPYRIDAMOLE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64980-134
Application NumberANDA040733
Product Classification
M
Marketing Category
C73584
G
Generic Name
DIPYRIDAMOLE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2022
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
DIPYRIDAMOLEActive
Quantity: 50 mg in 1 1
Code: 64ALC7F90C
Classification: ACTIB
DIPYRIDAMOLE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64980-133
Application NumberANDA040733
Product Classification
M
Marketing Category
C73584
G
Generic Name
DIPYRIDAMOLE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2022
FDA Product Classification
INGREDIENTS (8)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
DIPYRIDAMOLEActive
Quantity: 25 mg in 1 1
Code: 64ALC7F90C
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT