NDC Package 66621-1010-6 Orfadin

View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

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

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:

66621-1010-6

Package Description:

60 CAPSULE in 1 BOTTLE

Product Code:

66621-1010

Proprietary Name:

Orfadin

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:

66621101006

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

60 EA

Labeler Name:

Rare Disease Therapeutics, Inc.

Sample Package:

FDA Application Number:

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 Date:

07-31-2015

Exclude Flag:

Code Structure:

66621 - Rare Disease Therapeutics, Inc.
- 66621-1010 - Orfadin
  - 66621-1010-6 - 60 CAPSULE in 1 BOTTLE

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 66621-1010-6?

The NDC Packaged Code 66621-1010-6 is assigned to a package of 60 capsule in 1 bottle of Orfadin, labeled by Rare Disease Therapeutics, Inc.. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package.

Is NDC 66621-1010 included in the NDC Directory?

No, Orfadin with product code 66621-1010 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Rare Disease Therapeutics, Inc. on January 18, 2002 and its listing in the NDC Directory is set to expire on July 31, 2015 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 66621-1010-6?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 60.

What is the 11-digit format for NDC 66621-1010-6?

The 11-digit format is 66621101006. 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 5-4-1 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-4-1	66621-1010-6	5-4-2	66621-1010-06

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