Pretomanid Tablet
NDC Package 49502-476-93

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

Package Information

Pretomanid tablets is limited Population: Pretomanid Tablet is indicated, as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary extensively drug resistant (XDR) or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB). This formulation utilizes a tablet delivery system. Marketed by Viatris Specialty Llc, this product is identified by NDC 49502-476 and is authorized under FDA application NDA212862.

Identification & Billing

NDC Package Code
49502-476-93
Package Description
1 BOTTLE in 1 CARTON / 30 TABLET in 1 BOTTLE
Product Code
49502-476
11-Digit Billing Format
49502047693
RxNorm Crosswalk
RxCUI: 2198370 - pretomanid 200 MG Oral Tablet

Clinical Specifications

Proprietary Name
Pretomanid
Non-Proprietary Name
Pretomanid
Substance Name
Pretomanid
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)
PRETOMANID 200 mg/1
Pharmacologic Class
Usage Information
Limited Population: Pretomanid Tablet is indicated, as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary extensively drug resistant (XDR) or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB). Approval of this indication is based on limited clinical safety and efficacy data. This drug is indicated for use in a limited and specific population of patients.Limitations of Use:•Pretomanid Tablets are not indicated in patients with the following conditions:oDrug-sensitive (DS) tuberculosis oLatent infection due to Mycobacterium tuberculosis.oExtra-pulmonary infection due to Mycobacterium tuberculosis.oMDR-TB that is not treatment-intolerant or nonresponsive to standard therapy.•Safety and effectiveness of Pretomanid Tablets have not been established for its use in combination with drugs other than bedaquiline and linezolid as part of the recommended dosing regimen [see Dosage and Administration (2.2)].

Regulatory & Marketing

Labeler Name
Viatris Specialty Llc
Product Type
Human Prescription Drug
FDA Application #
NDA212862
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-07-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (49502-476). Click a package code to view its specific billing and regulatory data.

49502-476-26
1 BOTTLE in 1 CARTON / 26 TABLET in 1 BOTTLE
49502-476-28
2 BLISTER PACK in 1 CARTON / 14 TABLET in 1 BLISTER PACK (49502-476-32)

* 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 49502-476-93 identifies a specific commercial package of 1 bottle in 1 carton / 30 tablet in 1 bottle of Pretomanid, a human prescription drug labeled by Viatris Specialty Llc. This tablet is formulated for oral use and contains pretomanid 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 Viatris Specialty Llc on November 07, 2019. The current certification is valid through December 31, 2026.

How is this Viatris Specialty Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49502047693. 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)
49502-476-93
11-Digit CMS (5-4-2)
49502-0476-93

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