Nitisinone Tablet
NDC Package 63069-072-60

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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 Penn Pharmaceutical Services Ltd, this product is identified by NDC 63069-072.

Identification & Billing

NDC Package Code
63069-072-60
Package Description
60 TABLET in 1 BOTTLE
Product Code
63069-072
11-Digit Billing Format
63069007260

Clinical Specifications

Proprietary Name
Nitisinone
Non-Proprietary Name
Nitisinone
Substance Name
Nitisinone
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Active Ingredient(s)
NITISINONE 2 mg/1
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
Penn Pharmaceutical Services Ltd
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
07-26-2017
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 63069-072-60 identifies a specific commercial package of 60 tablet in 1 bottle of Nitisinone (UNFINISHED drug), drug for further processing labeled by Penn Pharmaceutical Services Ltd. This tablet is formulated for 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 Penn Pharmaceutical Services 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 Penn Pharmaceutical Services Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63069007260. 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)
63069-072-60
11-Digit CMS (5-4-2)
63069-0072-60

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