Tirofiban
These highlights do not include all the information needed to use TIROFIBAN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for TIROFIBAN HYDROCHLORIDE INJECTION. TIROFIBAN HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1998
Approved
Approval ID
d554acff-22e9-4f28-b826-ee1b91daa2df
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 13, 2023
Manufacturers
FDA
Eugia US LLC
DUNS: 968961354
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 Code55150-429
Application NumberANDA216379
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tirofiban
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 13, 2023
FDA Product Classification
INGREDIENTS (5)
TIROFIBAN HYDROCHLORIDEActive
Quantity: 5 mg in 100 mL
Code: 6H925F8O5J
Classification: ACTIM
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Tirofiban
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-430
Application NumberANDA216379
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tirofiban
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 13, 2023
FDA Product Classification
INGREDIENTS (5)
TIROFIBAN HYDROCHLORIDEActive
Quantity: 12.5 mg in 250 mL
Code: 6H925F8O5J
Classification: ACTIM
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT