Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
USV Private Limited
USV Private Limited
650434348
Products1
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
62147-0600Application Number
ANDA204362Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
March 18, 2019EptifibatideActive
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
WATERInactive
Code: 059QF0KO0RClass: IACT