Tobi Podhaler Capsule
NDC Package 49502-401-24

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

Tobi Podhaler (tobramycin) capsules is a medication used to treat people with cystic fibrosis who have a persistent lung infection with a certain bacteria (Pseudomonas aeruginosa). This formulation utilizes a capsule delivery system. Marketed by Viatris Specialty Llc, this product is identified by NDC 49502-401 and is authorized under FDA application NDA201688.

Identification & Billing

NDC Package Code
49502-401-24
Package Description
4 PACKAGE in 1 BOX, UNIT-DOSE / 7 BLISTER PACK in 1 PACKAGE / 8 CAPSULE in 1 BLISTER PACK
Product Code
49502-401
11-Digit Billing Format
49502040124
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4 EA

Clinical Specifications

Proprietary Name
Tobi Podhaler
Non-Proprietary Name
Tobramycin
Substance Name
Tobramycin
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
  • Oral - Administration to or by way of the mouth.
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
TOBRAMYCIN 28 mg/1
Pharmacologic Class
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
Product Type
Human Prescription Drug
FDA Application #
NDA201688
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-01-2021
Listing Expiration
12-31-2027
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 (49502-401). Click a package code to view its specific billing and regulatory data.

49502-401-09
8 CAPSULE in 1 BOX, UNIT-DOSE
49502-401-57
7 BLISTER PACK in 1 BOX, UNIT-DOSE / 8 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 49502-401-24 identifies a specific commercial package of 4 package in 1 box, unit-dose / 7 blister pack in 1 package / 8 capsule in 1 blister pack of Tobi Podhaler, a human prescription drug labeled by Viatris Specialty Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 4 billable units per package. This capsule is formulated for oral; respiratory (inhalation) use and contains tobramycin 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 September 01, 2021. The current certification is valid through December 31, 2027.

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: 49502040124. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 4 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)
49502-401-24
11-Digit CMS (5-4-2)
49502-0401-24

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