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  5. NDC Package Code: 71336-1002-1 Oxlumo

NDC Package 71336-1002-1 Oxlumo

Lumasiran Injection, Solution Subcutaneous - 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:
71336-1002-1
Package Description:
1 VIAL, SINGLE-USE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-USE
Product Code:
71336-1002
Proprietary Name:
Oxlumo
Non-Proprietary Name:
Lumasiran
Substance Name:
Lumasiran
Usage Information:
OXLUMO is indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients [see Clinical Pharmacology (12.1), Clinical Studies (14.1, 14.2)].
11-Digit NDC Billing Format:
71336100201
NDC to RxNorm Crosswalk:
  • RxCUI: 2467153 - lumasiran 94.5 MG in 0.5 ML Injection
  • RxCUI: 2467153 - 0.5 ML lumasiran 189 MG/ML Injection
  • RxCUI: 2467153 - lumasiran 94.5 MG (as lumasiran sodium 100 MG) per 0.5 ML Injection
  • RxCUI: 2467153 - lumasiran 94.5 MG per 0.5 ML Injection
  • RxCUI: 2467158 - OXLUMO 94.5 MG in 0.5 ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Alnylam Pharmaceuticals, Inc.
    Dosage Form:
    Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    Administration Route(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • LUMASIRAN 94.5 mg/.5mL
    • Sample Package:
    No
    FDA Application Number:
    NDA214103
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    11-23-2020
    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 71336-1002-1?

    The NDC Packaged Code 71336-1002-1 is assigned to a package of 1 vial, single-use in 1 carton / .5 ml in 1 vial, single-use of Oxlumo, a human prescription drug labeled by Alnylam Pharmaceuticals, Inc.. The product's dosage form is injection, solution and is administered via subcutaneous form.

    Is NDC 71336-1002 included in the NDC Directory?

    Yes, Oxlumo with product code 71336-1002 is active and included in the NDC Directory. The product was first marketed by Alnylam Pharmaceuticals, Inc. on November 23, 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 71336-1002-1?

    The 11-digit format is 71336100201. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-171336-1002-15-4-271336-1002-01