Prasugrel
PRASUGREL TABLETS. These highlights do not include all the information needed to use PRASUGREL TABLETS safely and effectively. See full prescribing information for PRASUGREL TABLETS. PRASUGREL tablets, for oral use Initial U.S. Approval: 2009
Approved
Approval ID
bb78f952-69a5-1620-e053-2a95a90afe97
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2022
Manufacturers
FDA
Golden State Medical Supply, Inc.
DUNS: 603184490
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Prasugrel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51407-445
Application NumberANDA205927
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prasugrel
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2022
FDA Product Classification
INGREDIENTS (13)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SUCROSE, 6-STEARATEInactive
Code: 114S1GA41U
Classification: IACT
PRASUGREL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: G89JQ59I13
Classification: ACTIM
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Prasugrel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51407-444
Application NumberANDA205927
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prasugrel
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2022
FDA Product Classification
INGREDIENTS (12)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSE, 6-STEARATEInactive
Code: 114S1GA41U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
PRASUGREL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: G89JQ59I13
Classification: ACTIM