Bethkis Solution
NDC Package 10122-820-28

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Bethkis (tobramycin) solution 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 solution delivery system. Marketed by Chiesi Usa, Inc., this product is identified by NDC 10122-820 and is authorized under FDA application NDA201820.

Identification & Billing

NDC Package Code
10122-820-28
Package Description
7 POUCH in 1 CARTON / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE
Product Code
10122-820
11-Digit Billing Format
10122082028
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bethkis
Non-Proprietary Name
Tobramycin
Substance Name
Tobramycin
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
TOBRAMYCIN 300 mg/4mL
Pharmacologic Class
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
Chiesi Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA201820
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-15-2013
Listing Expiration
12-31-2026
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J7682
Source: ASP
Tobramycin non-comp unit
HCPCS Dosage 300 MG
Units / Pkg 28

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 (10122-820). Click a package code to view its specific billing and regulatory data.

10122-820-04
4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE
10122-820-56
14 POUCH in 1 CARTON / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE

* 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 10122-820-28 identifies a specific commercial package of 7 pouch in 1 carton / 4 ampule in 1 pouch / 4 ml in 1 ampule of Bethkis, a human prescription drug labeled by Chiesi Usa, Inc.. This solution is formulated for 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 Chiesi Usa, Inc. on April 15, 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 Chiesi Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10122082028. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
10122-820-28
11-Digit CMS (5-4-2)
10122-0820-28

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