Terbutaline Sulfate
NDC Package 62778-080-22

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Terbutaline Sulfate is terbutaline is used to treat wheezing and shortness of breath from lung problems (e.g., asthma, chronic obstructive pulmonary disease-COPD, bronchitis, emphysema). Marketed by Hikma Farmaceutica, this product is identified by NDC 62778-080 and is authorized under FDA application ANDA078630.

Identification & Billing

NDC Package Code
62778-080-22
Package Description
10 VIAL in 1 CARTON / 1 mL in 1 VIAL (62778-080-21)
Product Code
62778-080
11-Digit Billing Format
62778008022

Clinical Specifications

Proprietary Name
Terbutaline Sulfate
Dosage Form
-
Usage Information
Terbutaline is used to treat wheezing and shortness of breath from lung problems (e.g., asthma, chronic obstructive pulmonary disease-COPD, bronchitis, emphysema). Terbutaline belongs to a class of drugs known as bronchodilators. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily.

Regulatory & Marketing

Labeler Name
Hikma Farmaceutica
FDA Application #
ANDA078630
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-20-2009
End Marketing Date
05-20-2009
Listing Expiration
05-20-2009
Exclude Flag
D
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 62778-080-22 identifies a specific commercial package of 10 vial in 1 carton / 1 ml in 1 vial (62778-080-21) of Terbutaline Sulfate, labeled by Hikma Farmaceutica. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Hikma Farmaceutica on May 20, 2009. The current certification is valid through May 20, 2009.

What are the primary indications for this medication?

Terbutaline is used to treat wheezing and shortness of breath from lung problems (e.g., asthma, chronic obstructive pulmonary disease-COPD, bronchitis, emphysema). Terbutaline belongs to a class of drugs known as bronchodilators. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily.

How is this Hikma Farmaceutica product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62778008022. 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)
62778-080-22
11-Digit CMS (5-4-2)
62778-0080-22

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