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  5. NDC Package Code: 66658-204-90 Orfadin

NDC Package 66658-204-90 Orfadin

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

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

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:
66658-204-90
Package Description:
1 BOTTLE, GLASS in 1 CARTON / 90 mL in 1 BOTTLE, GLASS
Product Code:
66658-204
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:
66658020490
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1790310 - nitisinone 4 MG in 1 mL Oral Suspension
  • RxCUI: 1790310 - nitisinone 4 MG/ML Oral Suspension
  • RxCUI: 1790310 - nitisinone 4 MG per 1 ML Oral Suspension
  • RxCUI: 1790317 - Orfadin 4 MG in 1 mL Oral Suspension
  • RxCUI: 1790317 - nitisinone 4 MG/ML Oral Suspension [Orfadin]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Swedish Orphan Biovitrum Ab (publ)
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • NITISINONE 4 mg/mL
    • Pharmacologic Class(es):
  • 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Cytochrome P450 2C9 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 2E1 Inducers - [MoA] (Mechanism of Action)
  • Hydroxyphenylpyruvate Dioxygenase Inhibitors - [MoA] (Mechanism of Action)
  • Organic Anion Transporter 1 Inhibitors - [MoA] (Mechanism of Action)
  • Organic Anion Transporter 3 Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA206356
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    06-01-2016
    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 66658-204-90?

    The NDC Packaged Code 66658-204-90 is assigned to a package of 1 bottle, glass in 1 carton / 90 ml in 1 bottle, glass of Orfadin, a human prescription drug labeled by Swedish Orphan Biovitrum Ab (publ). The product's dosage form is suspension and is administered via oral form.

    Is NDC 66658-204 included in the NDC Directory?

    Yes, Orfadin with product code 66658-204 is active and included in the NDC Directory. The product was first marketed by Swedish Orphan Biovitrum Ab (publ) on June 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 66658-204-90?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 66658-204-90?

    The 11-digit format is 66658020490. 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
    5-3-266658-204-905-4-266658-0204-90