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  5. NDC Package Code: 68135-000-99 Laronidase

NDC Package 68135-000-99 Laronidase

Injection, Solution, Concentrate - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
68135-000-99
Package Description:
20000 mL in 1 BAG
Product Code:
68135-000
Non-Proprietary Name:
Laronidase
Substance Name:
Laronidase
11-Digit NDC Billing Format:
68135000099
Product Type:
Drug For Further Processing
Labeler Name:
Biomarin Pharmaceutical Inc.
Dosage Form:
Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
Active Ingredient(s):
  • LARONIDASE 2.9 mg/5mL
    • Sample Package:
    N/A
    Marketing Category:
    DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
    Start Marketing Date:
    04-30-2003
    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.

    Frequently Asked Questions

    What is NDC 68135-000-99?

    The NDC Packaged Code 68135-000-99 is assigned to an UNFINISHED drug package of 20000 ml in 1 bag of Laronidase, drug for further processing labeled by Biomarin Pharmaceutical Inc.. The product's dosage form is injection, solution, concentrate and is administered via form.

    Is NDC 68135-000 included in the NDC Directory?

    Yes, Laronidase is an UNFINISHED PRODUCT with code 68135-000 that is active and included in the NDC Directory. The product was first marketed by Biomarin Pharmaceutical Inc. on April 30, 2003 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 68135-000-99?

    The 11-digit format is 68135000099. 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
    5-3-268135-000-995-4-268135-0000-99