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  5. NDC Package Code: 52958-040-01 Eptifibatide

NDC Package 52958-040-01 Eptifibatide

Injection, Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Eptifibatide
Non-Proprietary Name:
Eptifibatide
Substance Name:
Eptifibatide
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)
11-Digit NDC Billing Format:
52958004001
NDC to RxNorm Crosswalk:
  • RxCUI: 1736470 - eptifibatide 20 MG in 10 ML Injection
  • RxCUI: 1736470 - 10 ML eptifibatide 2 MG/ML Injection
  • RxCUI: 1736470 - eptifibatide 20 MG per 10 ML Injection
  • RxCUI: 200349 - eptifibatide 75 MG in 100 ML Injection
  • RxCUI: 200349 - 100 ML eptifibatide 0.75 MG/ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hainan Shuangcheng Pharmaceuticals Co., Ltd.
    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(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • EPTIFIBATIDE .75 mg/mL
    • Pharmacologic Class(es):
  • Decreased Platelet Aggregation - [PE] (Physiologic Effect)
  • Platelet Aggregation Inhibitor - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA213081
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-21-2022
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 52958-040-01?

    The NDC Packaged Code 52958-040-01 is assigned to a 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.. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 52958-040 included in the NDC Directory?

    Yes, Eptifibatide with product code 52958-040 is active and included in the NDC Directory. The product was first marketed by Hainan Shuangcheng Pharmaceuticals Co., Ltd. on April 21, 2022 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 52958-040-01?

    The 11-digit format is 52958004001. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-252958-040-015-4-252958-0040-01