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  5. NDC Package Code: 59676-702-60 Sirturo

NDC Package 59676-702-60 Sirturo

Bedaquiline Fumarate Tablet 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:
59676-702-60
Package Description:
60 TABLET in 1 BOTTLE
Product Code:
59676-702
Proprietary Name:
Sirturo
Non-Proprietary Name:
Bedaquiline Fumarate
Substance Name:
Bedaquiline Fumarate
Usage Information:
This medication must be used with other medications to treat active multi-drug-resistant tuberculosis (TB) of the lungs in people with limited treatment options. Bedaquiline belongs to a class of drugs known as antibiotics. It works by stopping the growth of the bacteria that causes TB. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.
11-Digit NDC Billing Format:
59676070260
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
60 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1364509 - bedaquiline 100 MG Oral Tablet
  • RxCUI: 1364509 - bedaquiline 100 MG (as bedaquiline fumarate 120.9 MG) Oral Tablet
  • RxCUI: 1364515 - Sirturo 100 MG Oral Tablet
  • RxCUI: 1364515 - bedaquiline 100 MG Oral Tablet [Sirturo]
  • RxCUI: 1364515 - Sirturo 100 MG (as bedaquiline fumarate 120.9 MG) Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Janssen Products, Lp
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • BEDAQUILINE FUMARATE 20 mg/1
    • Pharmacologic Class(es):
  • Diarylquinoline Antimycobacterial - [EPC] (Established Pharmacologic Class)
  • Diarylquinolines - [CS]
    • Sample Package:
    No
    FDA Application Number:
    NDA204384
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    05-27-2020
    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 59676-702-60?

    The NDC Packaged Code 59676-702-60 is assigned to a package of 60 tablet in 1 bottle of Sirturo, a human prescription drug labeled by Janssen Products, Lp. The product's dosage form is tablet and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package.

    Is NDC 59676-702 included in the NDC Directory?

    Yes, Sirturo with product code 59676-702 is active and included in the NDC Directory. The product was first marketed by Janssen Products, Lp on May 27, 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 NDC billing unit for package 59676-702-60?

    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 60.

    What is the 11-digit format for NDC 59676-702-60?

    The 11-digit format is 59676070260. 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
    5-3-259676-702-605-4-259676-0702-60