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FDA Approval

Eptifibatide

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
April 27, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Eptifibatide(2 mg in 1 mL)

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
14335-070
Application Number
ANDA209864
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
April 27, 2021
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Code: NA8320J834Class: ACTIBQuantity: 2 mg in 1 mL

Eptifibatide

Product Details

NDC Product Code
14335-071
Application Number
ANDA209864
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
April 27, 2021
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Code: NA8320J834Class: ACTIBQuantity: 0.75 mg in 1 mL
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