Nityr Tablet
NDC Package 70709-005-60

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Nityr (nitisinone) tablets is nitisinone is used to treat a certain inherited disorder (hereditary tyrosinemia type 1, also known as HT-1). This formulation utilizes a tablet delivery system. Marketed by Cycle Pharmaceuticals Ltd., this product is identified by NDC 70709-005 and is authorized under FDA application NDA209449.

Identification & Billing

NDC Package Code
70709-005-60
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 60 TABLET in 1 BOTTLE, PLASTIC
Product Code
70709-005
11-Digit Billing Format
70709000560
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nityr
Non-Proprietary Name
Nitisinone
Substance Name
Nitisinone
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NITISINONE 5 mg/1
Pharmacologic Class
Usage Information
Nitisinone is used to treat a certain inherited disorder (hereditary tyrosinemia type 1, also known as HT-1). HT-1 is usually discovered in infants and needs lifelong treatment. This condition is caused by a shortage of a certain natural substance that is needed to break down a nutrient (tyrosine) found in food. This effect causes a build-up of too much tyrosine and related substances in the liver. Nitisinone works by helping to prevent the formation and build-up of several toxic substances that cause damage to the liver, kidneys, and nervous system. This drug must be used along with a diet low in protein, tyrosine, and phenylalanine.

Regulatory & Marketing

Labeler Name
Cycle Pharmaceuticals Ltd.
Product Type
Human Prescription Drug
FDA Application #
NDA209449
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-26-2017
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70709-005-60 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 60 tablet in 1 bottle, plastic of Nityr, a human prescription drug labeled by Cycle Pharmaceuticals Ltd.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This tablet is formulated for oral use and contains nitisinone as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Cycle Pharmaceuticals Ltd. on July 26, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Nitisinone is used to treat a certain inherited disorder (hereditary tyrosinemia type 1, also known as HT-1). HT-1 is usually discovered in infants and needs lifelong treatment. This condition is caused by a shortage of a certain natural substance that is needed to break down a nutrient (tyrosine) found in food. This effect causes a build-up of too much tyrosine and related substances in the liver. Nitisinone works by helping to prevent the formation and build-up of several toxic substances that cause damage to the liver, kidneys, and nervous system. This drug must be used along with a diet low in protein, tyrosine, and phenylalanine.

How is this Cycle Pharmaceuticals Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70709000560. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
70709-005-60
11-Digit CMS (5-4-2)
70709-0005-60

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.