Nityr (nitisinone) NDC 70709-000

NDC codes

FDA NDC Directory

Product NDC (as listed)70709-000Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70709-0000Add 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
70709-000-60	70709000060	1 BOTTLE, PLASTIC in 1 CARTON (70709-000-60) / 60 TABLET in 1 BOTTLE, PLASTICMarketed from Jul 26, 2017

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): Nityr
Generic name (nonproprietary): nitisinone
Active ingredients: Nitisinone — 10 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 26, 2017
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 70709-000_9e29c768-8b6d-40c0-a8ee-72dfcf4dbe92SPL ID 9e29c768-8b6d-40c0-a8ee-72dfcf4dbe92SPL set ID 00fd1905-27e4-420e-8dc5-a69e4ddc1526RxCUI 1941464, 1941470, 1941471, 1941473, 1941474, 1941476UNII K5BN214699UPC 0370709000602, 0370709002606, 0370709005607
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

N470709000060 followed by a unit qualifier and the quantity

Package 70709-0000-60. 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 Dec 22, 2025.

Indications (excerpt from the label)

NITYR ® is indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. NITYR is a hydroxyphenyl-pyruvate dioxygenase inhibitor indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. ( 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 2 mg/1	TabletOral	Cycle Pharmaceuticals Ltd.	70709-002
Harlikunitisinone	Nitisinone 2 mg/1	TabletOral	Cycle Pharmaceuticals Ltd.	70709-112