Terbutaline Sulfate Tablet
NDC Package 62559-721-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Terbutaline Sulfate tablets is terbutaline is used to treat wheezing and shortness of breath from lung problems (e.g., asthma, chronic obstructive pulmonary disease-COPD, bronchitis, emphysema). This formulation utilizes a tablet delivery system. Marketed by Ani Pharmaceuticals, Inc., this product is identified by NDC 62559-721 and is authorized under FDA application NDA017849.

Identification & Billing

NDC Package Code
62559-721-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
62559-721
11-Digit Billing Format
62559072101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Terbutaline Sulfate
Non-Proprietary Name
Terbutaline Sulfate
Substance Name
Terbutaline Sulfate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TERBUTALINE SULFATE 2.5 mg/1
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
Ani Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA017849
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
10-16-2018
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 62559-721-01 identifies a specific commercial package of 100 tablet in 1 bottle of Terbutaline Sulfate, a human prescription drug labeled by Ani Pharmaceuticals, Inc.. This tablet is formulated for oral use and contains terbutaline sulfate 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 Ani Pharmaceuticals, Inc. on October 16, 2018. The current certification is valid through December 31, 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 Ani Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62559072101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
62559-721-01
11-Digit CMS (5-4-2)
62559-0721-01

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