Terbutaline Sulfate Injection, Solution
NDC Package 63323-665-01

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

Package Information

Terbutaline Sulfate injection 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 injection, solution delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-665 and is authorized under FDA application ANDA076887.

Identification & Billing

NDC Package Code
63323-665-01
Package Description
25 VIAL, SINGLE-USE in 1 TRAY / 1 mL in 1 VIAL, SINGLE-USE (63323-665-00)
Product Code
63323-665
11-Digit Billing Format
63323066501
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Terbutaline Sulfate
Non-Proprietary Name
Terbutaline Sulfate
Substance Name
Terbutaline Sulfate
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
TERBUTALINE SULFATE 1 mg/mL
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
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA076887
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-10-2011
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.

J3105
Source: PDAC
INJECTION, TERBUTALINE SULFATE, UP TO 1 MG
HCPCS Dosage 1 MG
Units / Pkg

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 63323-665-01 identifies a specific commercial package of 25 vial, single-use in 1 tray / 1 ml in 1 vial, single-use (63323-665-00) of Terbutaline Sulfate, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This injection, solution is formulated for subcutaneous 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 Fresenius Kabi Usa, Llc on March 10, 2011. 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 Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63323066501. 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)
63323-665-01
11-Digit CMS (5-4-2)
63323-0665-01

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