Tobi Podhaler
NDC Package 49502-346-57

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Tobi Podhaler is a medication used to treat people with cystic fibrosis who have a persistent lung infection with a certain bacteria (Pseudomonas aeruginosa). Marketed by Viatris Specialty Llc, this product is identified by NDC 49502-346 and is authorized under FDA application NDA201688.

Identification & Billing

NDC Package Code
49502-346-57
Package Description
7 BLISTER PACK in 1 BOX, UNIT-DOSE / 8 CAPSULE in 1 BLISTER PACK
Product Code
49502-346
11-Digit Billing Format
49502034657

Clinical Specifications

Proprietary Name
Tobi Podhaler
Dosage Form
-
Usage Information
This medication is used to treat people with cystic fibrosis who have a persistent lung infection with a certain bacteria (Pseudomonas aeruginosa). People with cystic fibrosis produce thick, sticky mucus that can plug up the tubes, ducts and passageways in the lungs. This can result in serious breathing problems and infections in the lungs. Tobramycin belongs to a class of drugs known as aminoglycoside antibiotics. Tobramycin works by stopping the growth of bacteria, including Pseudomonas aeruginosa, that commonly infect the lungs of people with cystic fibrosis. This effect decreases lung infections and damage, and helps to improve breathing.

Regulatory & Marketing

Labeler Name
Viatris Specialty Llc
FDA Application #
NDA201688
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-24-2020
End Marketing Date
05-31-2023
Listing Expiration
05-31-2023
Exclude Flag
D
Sample Package
Yes

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 (49502-346). Click a package code to view its specific billing and regulatory data.

49502-346-24
224 PACKAGE in 1 BOX, UNIT-DOSE / 56 BLISTER PACK in 1 PACKAGE / 4 CAPSULE in 1 BLISTER PACK

* 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 49502-346-57 identifies a specific commercial package of 7 blister pack in 1 box, unit-dose / 8 capsule in 1 blister pack of Tobi Podhaler, labeled by Viatris Specialty Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Viatris Specialty Llc on September 24, 2020. The current certification is valid through May 31, 2023.

What are the primary indications for this medication?

This medication is used to treat people with cystic fibrosis who have a persistent lung infection with a certain bacteria (Pseudomonas aeruginosa). People with cystic fibrosis produce thick, sticky mucus that can plug up the tubes, ducts and passageways in the lungs. This can result in serious breathing problems and infections in the lungs. Tobramycin belongs to a class of drugs known as aminoglycoside antibiotics. Tobramycin works by stopping the growth of bacteria, including Pseudomonas aeruginosa, that commonly infect the lungs of people with cystic fibrosis. This effect decreases lung infections and damage, and helps to improve breathing.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49502034657. 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)
49502-346-57
11-Digit CMS (5-4-2)
49502-0346-57

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