Eptifibatide
These highlights do not include all the information needed to use EPTIFIBATIDE INJECTION safely and effectively. See full prescribing information for . EPTIFIBATIDE injection, for intravenous use Initial U.S. Approval: 1998
Approved
Approval ID
f48ecd1e-a2c3-45d1-9e2e-d9a8fb71a770
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 25, 2021
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 827748190
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 Code70121-1003
Application NumberANDA205581
Product Classification
M
Marketing Category
C73584
G
Generic Name
Eptifibatide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 25, 2021
FDA Product Classification
INGREDIENTS (4)
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
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Eptifibatide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70121-1002
Application NumberANDA205581
Product Classification
M
Marketing Category
C73584
G
Generic Name
Eptifibatide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 25, 2021
FDA Product Classification
INGREDIENTS (4)
EPTIFIBATIDEActive
Quantity: 2 mg in 1 mL
Code: NA8320J834
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 5.25 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT