Eptifibatide Injection, Solution
NDC Package 52958-040-01

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 daysSevere hypertension (systolic blood pressure >200 mm Hg or diastolic blood pressure >110 mm Hg) not adequately controlled on antihypertensive therapyMajor surgery within the preceding 6 weeksHistory of stroke within 30 days or any history of hemorrhagic strokeCurrent or planned administration of another parenteral GP IIb/IIIa inhibitorDependency on renal dialysisHypersensitivity 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 Hainan Shuangcheng Pharmaceuticals Co., Ltd., this product is identified by NDC 52958-040 and is authorized under FDA application ANDA213081.

Identification & Billing

NDC Package Code
52958-040-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 100 mL in 1 VIAL, SINGLE-DOSE
Product Code
52958-040
11-Digit Billing Format
52958004001
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 .75 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 daysSevere hypertension (systolic blood pressure >200 mm Hg or diastolic blood pressure >110 mm Hg) not adequately controlled on antihypertensive therapyMajor surgery within the preceding 6 weeksHistory of stroke within 30 days or any history of hemorrhagic strokeCurrent or planned administration of another parenteral GP IIb/IIIa inhibitorDependency on renal dialysisHypersensitivity to eptifibatide or any component of the product (hypersensitivity reactions that occurred included anaphylaxis and urticaria)

Regulatory & Marketing

Labeler Name
Hainan Shuangcheng Pharmaceuticals Co., Ltd.
Product Type
Human Prescription Drug
FDA Application #
ANDA213081
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-21-2022
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 52958-040-01 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 100 ml in 1 vial, single-dose of Eptifibatide, a human prescription drug labeled by Hainan Shuangcheng Pharmaceuticals Co., Ltd.. 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 Hainan Shuangcheng Pharmaceuticals Co., Ltd. on April 21, 2022. The current certification is valid through December 31, 2026.

How is this Hainan Shuangcheng Pharmaceuticals Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52958004001. 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)
52958-040-01
11-Digit CMS (5-4-2)
52958-0040-01

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