Tobramycin Powder
NDC Package 51846-1012-0

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 powders 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 powder delivery system. Marketed by Teva Pharmaceutical Works Private Limited Company, this product is identified by NDC 51846-1012.

Identification & Billing

NDC Package Code
51846-1012-0
Package Description
1 kg in 1 CARTON
Product Code
51846-1012
11-Digit Billing Format
51846101200

Clinical Specifications

Proprietary Name
Tobramycin
Non-Proprietary Name
Tobramycin
Substance Name
Tobramycin
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
TOBRAMYCIN 100 kg/100kg
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
Teva Pharmaceutical Works Private Limited Company
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
04-10-2013
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 51846-1012-0 identifies a specific commercial package of 1 kg in 1 carton of Tobramycin (UNFINISHED drug), a bulk ingredient labeled by Teva Pharmaceutical Works Private Limited Company. This powder 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 Teva Pharmaceutical Works Private Limited Company on April 10, 2013. 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 Teva Pharmaceutical Works Private Limited Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51846101200. 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)
51846-1012-0
11-Digit CMS (5-4-2)
51846-1012-00

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