Cystadrops Solution
NDC Package 55292-410-05

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

Package Information

Cystadrops (cysteamine hydrochloride) solution is cYSTADROPS is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis. This formulation utilizes a solution delivery system. Marketed by Recordati Rare Diseases, Inc., this product is identified by NDC 55292-410 and is authorized under FDA application NDA211302.

Identification & Billing

NDC Package Code
55292-410-05
Package Description
1 BOTTLE, GLASS in 1 BOX / 5 mL in 1 BOTTLE, GLASS
Product Code
55292-410
11-Digit Billing Format
55292041005

Clinical Specifications

Proprietary Name
Cystadrops
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 3.5 mg/mL
Pharmacologic Class
Usage Information
CYSTADROPS is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis.

Regulatory & Marketing

Labeler Name
Recordati Rare Diseases, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA211302
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-19-2020
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 55292-410-05 identifies a specific commercial package of 1 bottle, glass in 1 box / 5 ml in 1 bottle, glass of Cystadrops, a human prescription drug labeled by Recordati Rare Diseases, Inc.. 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 Recordati Rare Diseases, Inc. on August 19, 2020. The current certification is valid through December 31, 2026.

How is this Recordati Rare Diseases, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55292041005. 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)
55292-410-05
11-Digit CMS (5-4-2)
55292-0410-05

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