Eptifibatide Injection, Solution
NDC Package 83634-300-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Eptifibatide injection is treatment with eptifibatide is contraindicated in patients with: A history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days Severe hypertension (systolic blood pressure >200 mm Hg or diastolic blood pressure >110 mm Hg) not adequately controlled on antihypertensive therapy Major surgery within the preceding 6 weeks History of stroke within 30 days or any history of hemorrhagic stroke Current or planned administration of another parenteral GP IIb/IIIa inhibitor Dependency on renal dialysis Hypersensitivity to eptifibatide or any component of the product (hypersensitivity reactions that occurred included anaphylaxis and urticaria). This formulation utilizes a injection, solution delivery system. Marketed by Avenacy Inc., this product is identified by NDC 83634-300 and is authorized under FDA application ANDA213081.

Identification & Billing

NDC Package Code
83634-300-10
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE
Product Code
83634-300
11-Digit Billing Format
83634030010
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Eptifibatide
Non-Proprietary Name
Eptifibatide
Substance Name
Eptifibatide
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
EPTIFIBATIDE 2 mg/mL
Pharmacologic Class
Usage Information
Treatment with eptifibatide is contraindicated in patients with: A history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days Severe hypertension (systolic blood pressure >200 mm Hg or diastolic blood pressure >110 mm Hg) not adequately controlled on antihypertensive therapy Major surgery within the preceding 6 weeks History of stroke within 30 days or any history of hemorrhagic stroke Current or planned administration of another parenteral GP IIb/IIIa inhibitor Dependency on renal dialysis Hypersensitivity to eptifibatide or any component of the product (hypersensitivity reactions that occurred included anaphylaxis and urticaria)

Regulatory & Marketing

Labeler Name
Avenacy Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA213081
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-31-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 83634-300-10 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose of Eptifibatide, a human prescription drug labeled by Avenacy Inc.. This injection, solution is formulated for intravenous use and contains eptifibatide as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Avenacy Inc. on January 31, 2024. The current certification is valid through December 31, 2026.

How is this Avenacy Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83634030010. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
83634-300-10
11-Digit CMS (5-4-2)
83634-0300-10

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.