Terbutaline Sulfate
NDC Package 0404-9778-01

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 Henry Schein, Inc., this product is identified by NDC 0404-9778 and is authorized under FDA application ANDA078630.

Identification & Billing

NDC Package Code
0404-9778-01
Package Description
1 VIAL in 1 BAG / 1 mL in 1 VIAL
Product Code
0404-9778
11-Digit Billing Format
00404977801

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
Henry Schein, Inc.
FDA Application #
ANDA078630
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-07-2025
End Marketing Date
06-01-2026
Listing Expiration
06-01-2026
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 0404-9778-01 identifies a specific commercial package of 1 vial in 1 bag / 1 ml in 1 vial of Terbutaline Sulfate, labeled by Henry Schein, Inc.. 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 Henry Schein, Inc. on October 07, 2025. The current certification is valid through June 01, 2026.

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 Henry Schein, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00404977801. 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 (4-4-2)
0404-9778-01
11-Digit CMS (5-4-2)
00404-9778-01

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