NDC Compounded Drug 54288-831-01 Semaglutide

Injection Subcutaneous

Table of Contents

    1. Compounded Product Information
    2. NDC Crossover Products Matching Semaglutide Injection, 12.5 Mg/2.5 Ml (5 Mg/ml)
    3. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 54288-831
NDC Package Code 54288-831-01
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.		 54288083101
Package Description 14969 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.		 Semaglutide Injection, 12.5 Mg/2.5 Ml (5 Mg/ml)
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.		 Semaglutide Injection, 12.5 Mg/2.5 Ml (5 Mg/ml)
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.		 Semaglutide
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.		 Semaglutide is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Semaglutide is also used in people with type 2 diabetes and heart disease to lower the risk of death from heart attack or stroke. Semaglutide is similar to a natural hormone in your body (incretin). It works by causing insulin release in response to high blood sugar (such as after a meal) and decreasing the amount of sugar your liver makes. If you use insulin, semaglutide is not a substitute for insulin treatment.
Dosage Form Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Route Name Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Marketing Category OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Code 54288
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Bpi Labs Llc
Substance Name Semaglutide
Active Ingredients Information 12.5 mg/2.5 mL
Reporting Period 2024-1

NDC Crossover Products Matching Semaglutide

NDC crossover of Semaglutide Injection, 12.5 Mg/2.5 Ml (5 Mg/ml) with NDC 54288-831 a human compounded drug with other similar products matching the same substance name (Semaglutide) and the same administration route (subcutaneous) or dosage form (injection).

Frequently Asked Questions

What is the NDC number assigned to Semaglutide?

Semaglutide was assigned by its manufacturer with NDC product code 54288-831. 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 Semaglutide?

The NDC package code 54288-831-01 was assigned to a 14969 mL in 1 VIAL of semaglutide administered subcutaneous via injection.

Who manufactures this product?

Semaglutide is manufactured by an outsourced facility and labeled by Bpi Labs Llc. 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.

Which are the NDC crossover matchings for this product?

We found 5 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by Hybrid Pharma, BPI Labs LLC and Tailstorm Health INC with NDC product codes 26436-5608-2, 54288-826-01, 54288-827-01, 81483-0045-4 and 81483-0049-4.