NDC Compounded Drug 81483-0044-0 Albuterol Sulfate

Inhalant Respiratory (inhalation)

Compounded Drug Product Information

NDC Product Code 81483-0044
NDC Package Code 81483-0044-0
11-Digit NDC Billing Format NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
81483004400
Package Description 25 VIAL in 1 TRAY > 10 mL in 1 VIAL
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Compounded Drug
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Albuterol Sulfate
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Albuterol Sulfate
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
Albuterol Sulfate
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
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.
Dosage Form Inhalant - A special class of inhalations consisting of a drug or combination of drugs, that by virtue of their high vapor pressure can be carried by an air current into the nasal passage where they exert their effect; the container from which the inhalant generally is administered is known as an inhaler.
Route Name Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Marketing Category OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Code 81483
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Tailstorm Health Inc
Substance Name Albuterol Sulfate
Active Ingredients Information 5 mg/1 mL
Reporting Period 2024-1

Frequently Asked Questions

What is the NDC number assigned to Albuterol Sulfate?

Albuterol Sulfate was assigned by its manufacturer with NDC product code 81483-0044. This product is a drug classified as a human compounded drug. Compounded drugs are medications created by combining or altering existing drugs to meet the specific needs of certain patients. The NDC directory only includes information about compounded drugs from facilities that choose to assign NDC numbers to their products.

Which are the NDC package codes for Albuterol Sulfate?

The NDC package code 81483-0044-0 was assigned to a 25 VIAL in 1 TRAY > 10 mL in 1 VIAL of albuterol sulfate administered respiratory (inhalation) via inhalant.

Who manufactures this product?

Albuterol Sulfate is manufactured by an outsourced facility and labeled by Tailstorm Health Inc. All compounded drugs included in the NDC directory are classified as "Outsourcing Facility Compounded Human Drug Product (Exempt from Approval Requirements)". Outsourcing facilities are a type of drug compounding facility regulated under Section 503B of the FD&C Act could be eligible for exemptions from drug registration if they meet all the conditions specified under Section 503B.