Sirturo Tablet
NDC Package 59676-702-60

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Sirturo (bedaquiline fumarate) tablets is 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. This formulation utilizes a tablet delivery system. Marketed by Janssen Products, Lp, this product is identified by NDC 59676-702 and is authorized under FDA application NDA204384.

Identification & Billing

NDC Package Code
59676-702-60
Package Description
60 TABLET in 1 BOTTLE
Product Code
59676-702
11-Digit Billing Format
59676070260
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sirturo
Non-Proprietary Name
Bedaquiline Fumarate
Substance Name
Bedaquiline Fumarate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BEDAQUILINE FUMARATE 20 mg/1
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Janssen Products, Lp
Product Type
Human Prescription Drug
FDA Application #
NDA204384
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-27-2020
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 59676-702-60 identifies a specific commercial package of 60 tablet in 1 bottle of Sirturo, a human prescription drug labeled by Janssen Products, Lp. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This tablet is formulated for oral use and contains bedaquiline fumarate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Janssen Products, Lp on May 27, 2020. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Janssen Products, Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59676070260. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
59676-702-60
11-Digit CMS (5-4-2)
59676-0702-60

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.