Eptifibatide
These highlights do not include all the information needed to use EPTIFIBATIDE INJECTION safely and effectively. See full prescribing information for EPTIFIBATIDE INJECTION. EPTIFIBATIDE injection, for intravenous use Initial U.S. Approval: 1998
Approved
Approval ID
c488f1af-a82c-4360-8886-79520635561a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 21, 2022
Manufacturers
FDA
Hainan Shuangcheng Pharmaceuticals Co., Ltd.
DUNS: 421282282
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 Code52958-402
Application NumberANDA213081
Product Classification
M
Marketing Category
C73584
G
Generic Name
Eptifibatide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 21, 2022
FDA Product Classification
INGREDIENTS (3)
EptifibatideActive
Quantity: 2 mg in 1 mL
Code: NA8320J834
Classification: ACTIB
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Citric Acid MonohydrateInactive
Quantity: 5.25 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
Eptifibatide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52958-040
Application NumberANDA213081
Product Classification
M
Marketing Category
C73584
G
Generic Name
Eptifibatide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 21, 2022
FDA Product Classification
INGREDIENTS (3)
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