1. Home
  2. Labeler Index
  3. Nuray Chemicals Private Limited
  4. 58159-037
  5. NDC Package Code: 58159-037-01 Nitisinone

NDC Package 58159-037-01 Nitisinone

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
58159-037-01
Package Description:
35 kg in 1 DRUM
Product Code:
58159-037
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:
58159003701
Product Type:
Bulk Ingredient
Labeler Name:
Nuray Chemicals Private Limited
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s):
  • NITISINONE 35 kg/35kg
    • Sample Package:
    N/A
    Marketing Category:
    BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
    Start Marketing Date:
    02-05-2020
    Listing Expiration Date:
    12-31-2024
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    58159-037-0220 kg in 1 DRUM
    58159-037-0315 kg in 1 DRUM
    58159-037-0410 kg in 1 DRUM
    58159-037-055 kg in 1 DRUM

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 58159-037-01?

    The NDC Packaged Code 58159-037-01 is assigned to an UNFINISHED drug package of 35 kg in 1 drum of Nitisinone, a bulk ingredient labeled by Nuray Chemicals Private Limited. The product's dosage form is powder and is administered via form.

    Is NDC 58159-037 included in the NDC Directory?

    Yes, Nitisinone is an UNFINISHED PRODUCT with code 58159-037 that is active and included in the NDC Directory. The product was first marketed by Nuray Chemicals Private Limited on February 05, 2020 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 11-digit format for NDC 58159-037-01?

    The 11-digit format is 58159003701. 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
    5-3-258159-037-015-4-258159-0037-01