Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Eptifibatide
Product Details
NDC Product Code
67457-631Application Number
ANDA203258Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
December 17, 2018EptifibatideActive
Code: NA8320J834Class: ACTIBQuantity: 0.75 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 5.25 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Eptifibatide
Product Details
NDC Product Code
67457-629Application Number
ANDA203258Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
December 17, 2018EptifibatideActive
Code: NA8320J834Class: ACTIBQuantity: 2 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 5.25 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Eptifibatide
Product Details
NDC Product Code
67457-630Application Number
ANDA203258Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
December 17, 2018CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 5.25 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
EptifibatideActive
Code: NA8320J834Class: ACTIBQuantity: 2 mg in 1 mL