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
80b86c46-230c-0090-e053-2991aa0a8fc1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 27, 2021
Manufacturers
FDA
Hainan Poly Pharm. Co., Ltd.
DUNS: 654561638
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 Code14335-070
Application NumberANDA209864
Product Classification
M
Marketing Category
C73584
G
Generic Name
eptifibatide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 27, 2021
FDA Product Classification
INGREDIENTS (3)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
EPTIFIBATIDEActive
Quantity: 2 mg in 1 mL
Code: NA8320J834
Classification: ACTIB
eptifibatide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14335-071
Application NumberANDA209864
Product Classification
M
Marketing Category
C73584
G
Generic Name
eptifibatide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 27, 2021
FDA Product Classification
INGREDIENTS (3)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
EPTIFIBATIDEActive
Quantity: 0.75 mg in 1 mL
Code: NA8320J834
Classification: ACTIB