NDC Package 66658-110-60 Orfadin

Nitisinone Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

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:
66658-110-60
Package Description:
1 BOTTLE, PLASTIC in 1 CARTON / 60 CAPSULE in 1 BOTTLE, PLASTIC
Product Code:
Proprietary Name:
Orfadin
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:
66658011060
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1798999 - nitisinone 20 MG Oral Capsule
  • RxCUI: 1799001 - Orfadin 20 MG Oral Capsule
  • RxCUI: 1799001 - nitisinone 20 MG Oral Capsule [Orfadin]
  • RxCUI: 351173 - nitisinone 2 MG Oral Capsule
  • RxCUI: 351174 - nitisinone 5 MG Oral Capsule
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Swedish Orphan Biovitrum Ab (publ)
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    NDA021232
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    07-01-2016
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    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 66658-110-60?

    The NDC Packaged Code 66658-110-60 is assigned to a package of 1 bottle, plastic in 1 carton / 60 capsule in 1 bottle, plastic of Orfadin, a human prescription drug labeled by Swedish Orphan Biovitrum Ab (publ). The product's dosage form is capsule and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 66658-110 included in the NDC Directory?

    Yes, Orfadin with product code 66658-110 is active and included in the NDC Directory. The product was first marketed by Swedish Orphan Biovitrum Ab (publ) on July 01, 2016 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 66658-110-60?

    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 1.

    What is the 11-digit format for NDC 66658-110-60?

    The 11-digit format is 66658011060. 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
    5-3-266658-110-605-4-266658-0110-60