Pheburane (sodium phenylbutyrate) NDC 71770-200

NDC codes

FDA NDC Directory

Product NDC (as listed)71770-200Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71770-0200Add 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
71770-200-10	71770020010	1 KIT in 1 CARTON (71770-200-10) * 174 g in 1 BOTTLE (71770-210-10)Marketed from Aug 26, 2022

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): Pheburane
Generic name (nonproprietary): sodium phenylbutyrate
Dosage form: Kit
Labeler: Medunik USA
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 216513
Marketing start: Aug 26, 2022
Listing expires: Dec 31, 2027
Identifiers: Product ID 71770-200_a3f7a328-2f56-42f0-8775-4252a8ff58beSPL ID a3f7a328-2f56-42f0-8775-4252a8ff58beSPL set ID d15f2cbf-4d22-40b5-8ef9-16b9d323a7f9RxCUI 2610128, 2610134UNII NT6K61736TUPC 0371770200106

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N471770020010 followed by a unit qualifier and the quantity

Package 71770-0200-10. 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 Jul 17, 2026.

Indications (excerpt from the label)

PHEBURANE is indicated as adjunctive therapy to standard of care, which includes dietary management, for the chronic management of adult and pediatric patients with urea cycle disorders (UCDs), involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) or argininosuccinic acid synthetase (AS). Limitations of Use Episodes of acute hyperammonemia may occur in patients while on PHEBURANE. PHEBURANE is not indicated for the treatment of acute hyperammonemia, which can be a life-threatening medical emergency that requires rapid acting interventions to reduce plasma ammonia levels. PHEBURANE is a nitrogen-binding agent indicated as adjunctive therapy to standard…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 216513

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

FDA NDC Directory listings under NDA 216513
Product	Strength	Form · route	Labeler	Product NDC
Pheburanesodium phenylbutyrate	Sodium phenylbutyrate 483 mg/g	PelletOral	Medunik USA	71770-210