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  5. NDC Package Code: 63069-072-60 Nitisinone

NDC Package 63069-072-60 Nitisinone

Tablet - View Billable Units, 11-Digit Format, RxNorm

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.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
63069-072-60
Package Description:
60 TABLET in 1 BOTTLE
Product Code:
63069-072
Non-Proprietary Name:
Nitisinone
Substance Name:
Nitisinone
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.
11-Digit NDC Billing Format:
63069007260
Product Type:
Drug For Further Processing
Labeler Name:
Penn Pharmaceutical Services Ltd
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Active Ingredient(s):
NITISINONE 2 mg/1
Sample Package:
N/A
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 Date:
12-31-2025
Exclude Flag:
N
Unfinished Product:
Yes
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 63069-072-60?

The NDC Packaged Code 63069-072-60 is assigned to an UNFINISHED drug package of 60 tablet in 1 bottle of Nitisinone, drug for further processing labeled by Penn Pharmaceutical Services Ltd. The product's dosage form is tablet and is administered via form.

Is NDC 63069-072 included in the NDC Directory?

Yes, Nitisinone is an UNFINISHED PRODUCT with code 63069-072 that is active and included in the NDC Directory. The product was first marketed by Penn Pharmaceutical Services Ltd on July 26, 2017 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 63069-072-60?

The 11-digit format is 63069007260. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-263069-072-605-4-263069-0072-60