Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Hainan Shuangcheng Pharmaceuticals Co., Ltd.
Hainan Shuangcheng Pharmaceuticals Co., Ltd.
421282282
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
52958-402Application Number
ANDA213081Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
April 21, 2022EptifibatideActive
Code: NA8320J834Class: ACTIBQuantity: 2 mg in 1 mL
Sodium HydroxideInactive
Code: 55X04QC32IClass: IACT
Citric Acid MonohydrateInactive
Code: 2968PHW8QPClass: IACTQuantity: 5.25 mg in 1 mL
Eptifibatide
Product Details
NDC Product Code
52958-040Application Number
ANDA213081Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
April 21, 2022EptifibatideActive
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