Eptifibatide
NDC Package 14335-070-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Eptifibatide is treatment with eptifibatide injection 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 injection or any component of the product (hypersensitivity reactions that occurred included anaphylaxis and urticaria). Marketed by Hainan Poly Pharm. Co., Ltd., this product is identified by NDC 14335-070 and is authorized under FDA application ANDA209864.

Identification & Billing

NDC Package Code
14335-070-01
Package Description
10 mL in 1 VIAL
Product Code
14335-070
11-Digit Billing Format
14335007001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Eptifibatide
Dosage Form
-
Usage Information
Treatment with eptifibatide injection 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 injection or any component of the product (hypersensitivity reactions that occurred included anaphylaxis and urticaria).

Regulatory & Marketing

Labeler Name
Hainan Poly Pharm. Co., Ltd.
FDA Application #
ANDA209864
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-22-2019
Listing Expiration
12-31-2022
Exclude Flag
I
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 14335-070-01 identifies a specific commercial package of 10 ml in 1 vial of Eptifibatide, labeled by Hainan Poly Pharm. Co., Ltd.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Hainan Poly Pharm. Co., Ltd. on July 22, 2019. The current certification is valid through December 31, 2022.

How is this Hainan Poly Pharm. Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 14335007001. 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)
14335-070-01
11-Digit CMS (5-4-2)
14335-0070-01

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