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  5. NDC Package Code: 54482-020-02 Cystaran

NDC Package 54482-020-02 Cystaran

Cysteamine Hydrochloride Solution Ophthalmic - 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:
54482-020-02
Package Description:
15 mL in 1 BOTTLE
Product Code:
54482-020
Proprietary Name:
Cystaran
Non-Proprietary Name:
Cysteamine Hydrochloride
Substance Name:
Cysteamine Hydrochloride
Usage Information:
Cysteamine is used to treat eye problems in people with cystinosis, a hereditary metabolic disorder that causes build-up of a certain natural substance (cystine) in the body. This medication helps get rid of cystine build-up in the eyes.
11-Digit NDC Billing Format:
54482002002
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
15 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 1313780 - cysteamine HCl 0.44 % Ophthalmic Solution
  • RxCUI: 1313780 - cysteamine 4.4 MG/ML Ophthalmic Solution
  • RxCUI: 1313780 - cysteamine 0.44 % Ophthalmic Solution
  • RxCUI: 1313780 - cysteamine 4.4 MG/ML (as cysteamine hydrochloride 6.5 MG/ML) Ophthalmic Solution
  • RxCUI: 1313785 - cystaran 0.44 % Ophthalmic Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Leadiant Biosciences, Inc.
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Ophthalmic - Administration to the external eye.
    • Active Ingredient(s):
  • CYSTEAMINE HYDROCHLORIDE 6.5 mg/mL
    • Pharmacologic Class(es):
  • Cystine Depleting Agent - [EPC] (Established Pharmacologic Class)
  • Cystine Disulfide Reduction - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA200740
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-30-2012
    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 54482-020-02?

    The NDC Packaged Code 54482-020-02 is assigned to a package of 15 ml in 1 bottle of Cystaran, a human prescription drug labeled by Leadiant Biosciences, Inc.. The product's dosage form is solution and is administered via ophthalmic form.This product is billed per "ML" milliliter and contains an estimated amount of 15 billable units per package.

    Is NDC 54482-020 included in the NDC Directory?

    Yes, Cystaran with product code 54482-020 is active and included in the NDC Directory. The product was first marketed by Leadiant Biosciences, Inc. on December 30, 2012 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 NDC billing unit for package 54482-020-02?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 15.

    What is the 11-digit format for NDC 54482-020-02?

    The 11-digit format is 54482002002. 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
    5-3-254482-020-025-4-254482-0020-02