Tobramycin 28mg Inhalation Powder Hard Capsule
NDC Package 50909-2001-1

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Tobramycin 28mg Inhalation Powder Hard Capsule capsules is a medication used to treat people with a certain inherited condition (cystic fibrosis) who have a persistent lung infection with a certain bacteria (Pseudomonas aeruginosa). This formulation utilizes a capsule delivery system. Marketed by Hovione Farmaciencia Sa, this product is identified by NDC 50909-2001.

Identification & Billing

NDC Package Code
50909-2001-1
Package Description
1 BAG in 1 CONTAINER / 8000 CAPSULE in 1 BAG
Product Code
50909-2001
11-Digit Billing Format
50909200101

Clinical Specifications

Proprietary Name
Tobramycin 28mg Inhalation Powder Hard Capsule
Non-Proprietary Name
Tobramycin 28mg Inhalation Powder Hard Capsule
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.
Active Ingredient(s)
TOBRAMYCIN 28 mg/1
Usage Information
This medication is used to treat people with a certain inherited condition (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 inhalation solution works by stopping the growth of a certain bacteria (Pseudomonas aeruginosa) that commonly infects the lungs of people with cystic fibrosis. This effect decreases lung infections and damage, and helps to improve breathing.

Regulatory & Marketing

Labeler Name
Hovione Farmaciencia Sa
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
11-20-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 50909-2001-1 identifies a specific commercial package of 1 bag in 1 container / 8000 capsule in 1 bag of Tobramycin 28mg Inhalation Powder Hard Capsule (UNFINISHED drug), drug for further processing labeled by Hovione Farmaciencia Sa. This capsule is formulated for 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 Hovione Farmaciencia Sa on November 20, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat people with a certain inherited condition (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 inhalation solution works by stopping the growth of a certain bacteria (Pseudomonas aeruginosa) that commonly infects the lungs of people with cystic fibrosis. This effect decreases lung infections and damage, and helps to improve breathing.

How is this Hovione Farmaciencia Sa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50909200101. 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 (5-4-1)
50909-2001-1
11-Digit CMS (5-4-2)
50909-2001-01

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