AGGRASTAT
These highlights do not include all the information needed to use AGGRASTAT® (tirofiban hydrochloride) safely and effectively. See full prescribing information for AGGRASTAT. AGGRASTAT (tirofiban hydrochloride) injection, for intravenous use
Approved
Approval ID
e850111f-e713-41a2-9c65-21c517cf5511
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2023
Manufacturers
FDA
Medicure International Inc
DUNS: 860240324
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TIROFIBAN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25208-901
Application NumberNDA020912
Product Classification
M
Marketing Category
C73594
G
Generic Name
TIROFIBAN
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 3, 2023
FDA Product Classification
INGREDIENTS (5)
TIROFIBAN HYDROCHLORIDEActive
Quantity: 3.75 mg in 15 mL
Code: 6H925F8O5J
Classification: ACTIM
ANHYDROUS CITRIC ACIDInactive
Quantity: 2.4 mg in 15 mL
Code: XF417D3PSL
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 40.5 mg in 15 mL
Code: B22547B95K
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 120 mg in 15 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TIROFIBAN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25208-902
Application NumberNDA020913
Product Classification
M
Marketing Category
C73594
G
Generic Name
TIROFIBAN
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 3, 2023
FDA Product Classification
INGREDIENTS (5)
ANHYDROUS CITRIC ACIDInactive
Quantity: 3.2 mg in 100 mL
Code: XF417D3PSL
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 54 mg in 100 mL
Code: B22547B95K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 900 mg in 100 mL
Code: 451W47IQ8X
Classification: IACT
TIROFIBAN HYDROCHLORIDEActive
Quantity: 5 mg in 100 mL
Code: 6H925F8O5J
Classification: ACTIM