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  5. NDC Package Code: 50909-2001-1 Tobramycin 28mg Inhalation Powder Hard Capsule

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

Capsule - View Billable Units, 11-Digit Format, RxNorm

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.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
50909-2001-1
Package Description:
1 BAG in 1 CONTAINER / 8000 CAPSULE in 1 BAG
Product Code:
50909-2001
Non-Proprietary Name:
Tobramycin 28mg Inhalation Powder Hard Capsule
Substance Name:
Tobramycin
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.
11-Digit NDC Billing Format:
50909200101
Product Type:
Drug For Further Processing
Labeler Name:
Hovione Farmaciencia Sa
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
Sample Package:
N/A
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 Date:
12-31-2026
Exclude Flag:
N
Unfinished Product:
Yes
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 50909-2001-1?

The NDC Packaged Code 50909-2001-1 is assigned to an UNFINISHED drug package of 1 bag in 1 container / 8000 capsule in 1 bag of Tobramycin 28mg Inhalation Powder Hard Capsule, drug for further processing labeled by Hovione Farmaciencia Sa. The product's dosage form is capsule and is administered via form.

Is NDC 50909-2001 included in the NDC Directory?

Yes, Tobramycin 28mg Inhalation Powder Hard Capsule is an UNFINISHED PRODUCT with code 50909-2001 that is active and included in the NDC Directory. The product was first marketed by Hovione Farmaciencia Sa on November 20, 2024 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 50909-2001-1?

The 11-digit format is 50909200101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-150909-2001-15-4-250909-2001-01