Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Gland Pharma Limited
Amneal Pharmaceuticals LLC
918601238
Products2
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
70121-1003Application Number
ANDA205581Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
July 25, 2021EptifibatideActive
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
WATERInactive
Code: 059QF0KO0RClass: IACT
Eptifibatide
Product Details
NDC Product Code
70121-1002Application Number
ANDA205581Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
July 25, 2021EptifibatideActive
Code: NA8320J834Class: ACTIBQuantity: 2 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 5.25 mg in 1 mL