Orfadin
NDC Package 66621-1010-6

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Orfadin is nitisinone is used to treat a certain inherited disorder (hereditary tyrosinemia type 1, also known as HT-1). Marketed by Rare Disease Therapeutics, Inc., this product is identified by NDC 66621-1010 and is authorized under FDA application NDA021232.

Identification & Billing

NDC Package Code
66621-1010-6
Package Description
60 CAPSULE in 1 BOTTLE
Product Code
11-Digit Billing Format
66621101006
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA

Clinical Specifications

Proprietary Name
Orfadin
Dosage Form
-
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
Rare Disease Therapeutics, Inc.
FDA Application #
NDA021232
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-18-2002
End Marketing Date
07-31-2015
Listing Expiration
07-31-2015
Exclude Flag
D
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 66621-1010-6 identifies a specific commercial package of 60 capsule in 1 bottle of Orfadin, labeled by Rare Disease Therapeutics, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Rare Disease Therapeutics, Inc. on January 18, 2002. The current certification is valid through July 31, 2015.

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 Rare Disease Therapeutics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66621101006. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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 (5-4-1)
66621-1010-6
11-Digit CMS (5-4-2)
66621-1010-06

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