Eptifibatide
These highlights do not include all the information needed to use Eptifibatide Injection safely and effectively. See full prescribing information for Eptifibatide Injection. Eptifibatide Injection, for intravenous use Initial U.S. Approval: 1998
Approved
Approval ID
ef0ad483-9086-4267-9b57-fcedd868719c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 26, 2019
Manufacturers
FDA
USV Private Limited
DUNS: 650611585
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Eptifibatide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62147-0602
Application NumberANDA204362
Product Classification
M
Marketing Category
C73584
G
Generic Name
Eptifibatide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 26, 2019
FDA Product Classification
INGREDIENTS (4)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 5.25 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
EPTIFIBATIDEActive
Quantity: 2 mg in 1 mL
Code: NA8320J834
Classification: ACTIB
Eptifibatide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62147-0601
Application NumberANDA204362
Product Classification
M
Marketing Category
C73584
G
Generic Name
Eptifibatide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 26, 2019
FDA Product Classification
INGREDIENTS (4)
EPTIFIBATIDEActive
Quantity: 0.75 mg in 1 mL
Code: NA8320J834
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 5.25 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT