Prasugrel
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
5edc1ab3-5c7a-47d6-8aaa-00523c9b4c8f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2023
Manufacturers
FDA
Unichem Pharmaceuticals (USA), Inc.
DUNS: 181620514
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 Code29300-301
Application NumberANDA213315
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prasugrel
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2023
FDA Product Classification
INGREDIENTS (12)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
SUCROSE STEARATEInactive
Code: 274KW0O50M
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PRASUGREL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: G89JQ59I13
Classification: ACTIM
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)Inactive
Code: NZ94SDL6WR
Classification: IACT
Prasugrel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code29300-302
Application NumberANDA213315
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prasugrel
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2023
FDA Product Classification
INGREDIENTS (12)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SUCROSE STEARATEInactive
Code: 274KW0O50M
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
PRASUGREL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: G89JQ59I13
Classification: ACTIM
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)Inactive
Code: NZ94SDL6WR
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT