Albuterol Sulfate Powder
NDC Package 11517-012-01

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Albuterol Sulfate powders is albuterol (also known as salbutamol) is used to treat wheezing and shortness of breath caused by breathing problems such as asthma. This formulation utilizes a powder delivery system. Marketed by Kindeva Drug Delivery Limited, this product is identified by NDC 11517-012.

Identification & Billing

NDC Package Code
11517-012-01
Package Description
23 kg in 1 DRUM
Product Code
11517-012
11-Digit Billing Format
11517001201

Clinical Specifications

Proprietary Name
Albuterol Sulfate
Non-Proprietary Name
Albuterol Sulfate
Substance Name
Albuterol Sulfate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
ALBUTEROL SULFATE 1 kg/kg
Usage Information
Albuterol (also known as salbutamol) is used to treat wheezing and shortness of breath caused by breathing problems such as asthma. It is a quick-relief medication. Albuterol 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. Controlling symptoms of breathing problems can decrease time lost from work or school.

Regulatory & Marketing

Labeler Name
Kindeva Drug Delivery Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
04-30-2015
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 11517-012-01 identifies a specific commercial package of 23 kg in 1 drum of Albuterol Sulfate (UNFINISHED drug), a bulk ingredient labeled by Kindeva Drug Delivery Limited. This powder is formulated for use and contains albuterol 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 Kindeva Drug Delivery Limited on April 30, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Albuterol (also known as salbutamol) is used to treat wheezing and shortness of breath caused by breathing problems such as asthma. It is a quick-relief medication. Albuterol 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. Controlling symptoms of breathing problems can decrease time lost from work or school.

How is this Kindeva Drug Delivery Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11517001201. 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)
11517-012-01
11-Digit CMS (5-4-2)
11517-0012-01

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