Cystaran (cysteamine hydrochloride) NDC 54482-035

NDC codes

FDA NDC Directory

Product NDC (as listed)54482-035Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54482-0035Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
54482-035-02	54482003502	15 mL in 1 BOTTLE (54482-035-02)Marketed from Apr 25, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Cystaran
Generic name (nonproprietary): cysteamine hydrochloride
Active ingredients: Cysteamine hydrochloride — 6.5 mg/mL
Dosage form: Solution
Route: Ophthalmic
Labeler: Leadiant Biosciences, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 200740
Marketing start: Dec 30, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Cystine Disulfide Reduction (Mechanism)
Identifiers: Product ID 54482-035_0ae95603-411c-455b-8bb8-8c5b01dac297SPL ID 0ae95603-411c-455b-8bb8-8c5b01dac297SPL set ID b98ee838-ed23-42a9-93b5-72579e490fbaRxCUI 1313780, 1313785UNII IF1B771SVB
Pharmacologic class: Cystine Depleting Agent

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N454482003502 followed by a unit qualifier and the quantity

Package 54482-0035-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Apr 30, 2025.

Indications (excerpt from the label)

CYSTARAN ® is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis. CYSTARAN is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 200740

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 200740
Product	Strength	Form · route	Labeler	Product NDC
Cystarancysteamine hydrochloride	Cysteamine hydrochloride 6.5 mg/mL	SolutionOphthalmic	Leadiant Biosciences, Inc.	54482-020