Cystaran Solution
NDC Package 54482-020-01

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

Package Information

Cystaran (cysteamine hydrochloride) solution is 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 formulation utilizes a solution delivery system. Marketed by Leadiant Biosciences, Inc., this product is identified by NDC 54482-020 and is authorized under FDA application NDA200740.

Identification & Billing

NDC Package Code
54482-020-01
Package Description
15 mL in 1 BOTTLE
Product Code
54482-020
11-Digit Billing Format
54482002001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
15 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cystaran
Non-Proprietary Name
Cysteamine Hydrochloride
Substance Name
Cysteamine Hydrochloride
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
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
CYSTEAMINE HYDROCHLORIDE 6.5 mg/mL
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Leadiant Biosciences, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA200740
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-30-2012
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54482-020). Click a package code to view its specific billing and regulatory data.

54482-020-02
15 mL in 1 BOTTLE

* 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 54482-020-01 identifies a specific commercial package of 15 ml in 1 bottle of Cystaran, a human prescription drug labeled by Leadiant Biosciences, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 15 billable units per package. This solution is formulated for ophthalmic use and contains cysteamine hydrochloride 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 Leadiant Biosciences, Inc. on December 30, 2012. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Leadiant Biosciences, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54482002001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 15 total billable units per package. 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)
54482-020-01
11-Digit CMS (5-4-2)
54482-0020-01

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