Harliku (nitisinone) NDC 70709-112

NDC codes

FDA NDC Directory

Product NDC (as listed)70709-112Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70709-0112Add 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
70709-112-60	70709011260	1 BOTTLE, PLASTIC in 1 CARTON (70709-112-60) / 60 TABLET in 1 BOTTLE, PLASTICMarketed from Jul 21, 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): Harliku
Generic name (nonproprietary): nitisinone
Active ingredients: Nitisinone — 2 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Cycle Pharmaceuticals Ltd.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 209449
Marketing start: Jul 21, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 2E1 Inducers (Mechanism)Hydroxyphenylpyruvate Dioxygenase Inhibitors (Mechanism)Organic Anion Transporter 1 Inhibitors (Mechanism)Organic Anion Transporter 3 Inhibitors (Mechanism)
Identifiers: Product ID 70709-112_2d883e57-720f-494e-be8f-db592ba0aa32SPL ID 2d883e57-720f-494e-be8f-db592ba0aa32SPL set ID 7cf67e24-d46b-4376-bbd0-0b973c406d0dRxCUI 1941474, 2719722UNII K5BN214699UPC 0370709112602
Pharmacologic class: 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor

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

N470709011260 followed by a unit qualifier and the quantity

Package 70709-0112-60. 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 2, 2025.

Indications (excerpt from the label)

HARLIKU TM is indicated for the reduction of urine homogentisic acid (HGA) in adult patients with alkaptonuria (AKU). HARLIKU is a hydroxyphenyl-pyruvate dioxygenase inhibitor indicated for the reduction of urine homogentisic acid (HGA) in adult patients with alkaptonuria (AKU). ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 209449

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

FDA NDC Directory listings under NDA 209449
Product	Strength	Form · route	Labeler	Product NDC
Nityrnitisinone	Nitisinone 5 mg/1	TabletOral	Cycle Pharmaceuticals Ltd.	70709-005
Nityrnitisinone	Nitisinone 10 mg/1	TabletOral	Cycle Pharmaceuticals Ltd.	70709-000
Nityrnitisinone	Nitisinone 2 mg/1	TabletOral	Cycle Pharmaceuticals Ltd.	70709-002