Terbutaline Sulfate
NDC Package 43063-059-04

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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 Pd-rx Pharmaceuticals, Inc., this product is identified by NDC 43063-059 and is authorized under FDA application ANDA075877.

Identification & Billing

NDC Package Code
43063-059-04
Package Description
4 TABLET in 1 BOTTLE, PLASTIC
Product Code
43063-059
11-Digit Billing Format
43063005904
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4 EA

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
Pd-rx Pharmaceuticals, Inc.
FDA Application #
ANDA075877
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-26-2001
End Marketing Date
08-20-2018
Listing Expiration
08-20-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (43063-059). Click a package code to view its specific billing and regulatory data.

43063-059-08
8 TABLET in 1 BOTTLE, PLASTIC

* 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 43063-059-04 identifies a specific commercial package of 4 tablet in 1 bottle, plastic of Terbutaline Sulfate, labeled by Pd-rx Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 4 billable units per package. 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 Pd-rx Pharmaceuticals, Inc. on June 26, 2001. The current certification is valid through August 20, 2018.

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 Pd-rx Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43063005904. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 4 total billable units per package. 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)
43063-059-04
11-Digit CMS (5-4-2)
43063-0059-04

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