Procysbi (cysteamine bitartrate) NDC 75987-100

NDC codes

FDA NDC Directory

Product NDC (as listed)75987-100Labeler and product segments. Claims need a package NDC.

Product NDC at billing width75987-0100Add 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
75987-100-04	75987010004	60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (75987-100-04)Marketed from Apr 30, 2013

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): Procysbi
Generic name (nonproprietary): cysteamine bitartrate
Active ingredients: Cysteamine bitartrate — 25 mg/1
Dosage form: Capsule, Delayed release pellets
Route: Oral
Labeler: Horizon Therapeutics USA, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 203389
Marketing start: Apr 30, 2013
Listing expires: Dec 31, 2027
Other FDA classes: Cystine Disulfide Reduction (Mechanism)
Identifiers: Product ID 75987-100_46e1ad21-f347-4113-8ea1-2a0fcb129391SPL ID 46e1ad21-f347-4113-8ea1-2a0fcb129391SPL set ID d3a3ec28-f746-463a-bb92-3bc8826db09eRxCUI 1421467, 1421473, 1421475, 1421477, 2284510, 2284514, 2284515, 2284516UNII QO84GZ3TST
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N475987010004 followed by a unit qualifier and the quantity

Package 75987-0100-04. 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 Jun 25, 2026.

Indications (excerpt from the label)

PROCYSBI is indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older. PROCYSBI is a cystine-depleting agent indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 203389

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

FDA NDC Directory listings under NDA 203389
Product	Strength	Form · route	Labeler	Product NDC
Procysbicysteamine bitartrate	Cysteamine bitartrate 75 mg/1	Capsule, Delayed release pelletsOral	Horizon Therapeutics USA, Inc.	75987-101