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 useInitial U.S. Approval: 1998
Approved
Approval ID
88a37f9c-496b-4a6b-9665-4550abba04f1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 28, 2021
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
Products 3
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 Code67457-631
Application NumberANDA203258
Product Classification
M
Marketing Category
C73584
G
Generic Name
eptifibatide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 17, 2018
FDA Product Classification
INGREDIENTS (3)
EPTIFIBATIDEActive
Quantity: 0.75 mg in 1 mL
Code: NA8320J834
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Quantity: 5.25 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
eptifibatide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67457-629
Application NumberANDA203258
Product Classification
M
Marketing Category
C73584
G
Generic Name
eptifibatide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 17, 2018
FDA Product Classification
INGREDIENTS (3)
EPTIFIBATIDEActive
Quantity: 2 mg in 1 mL
Code: NA8320J834
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Quantity: 5.25 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
eptifibatide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67457-630
Application NumberANDA203258
Product Classification
M
Marketing Category
C73584
G
Generic Name
eptifibatide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 17, 2018
FDA Product Classification
INGREDIENTS (3)
CITRIC ACID MONOHYDRATEInactive
Quantity: 5.25 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
EPTIFIBATIDEActive
Quantity: 2 mg in 1 mL
Code: NA8320J834
Classification: ACTIB