NDC Compounded Drug 83343-002-15

Injection, Solution Intravenous

Table of Contents

    1. Compounded Product Information
    2. NDC Crossover Products Matching Alpha Lipoic Acid
    3. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 83343-002
NDC Package Code 83343-002-15
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.		 83343000215
Package Description 5447 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.		 Alpha Lipoic Acid
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.		 Alpha Lipoic Acid
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.
Route Name Intravenous - Administration within or into a vein or veins.
Marketing Category OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Code 83343
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Mcguff Outsourcing Solutions Inc.
Reporting Period 2023-2

NDC Crossover Products Matching

NDC crossover of Alpha Lipoic Acid with NDC 83343-002 a human compounded drug with other similar products matching the same substance name () and the same administration route (intravenous) or dosage form (injection, solution).

Frequently Asked Questions

What is the NDC number assigned to Fentanyl Citrate 2500mcg/250ml (10mcg/ml) Bag?

Fentanyl Citrate 2500mcg/250ml (10mcg/ml) Bag was assigned by its manufacturer with NDC product code 83343-002. 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 Fentanyl Citrate 2500mcg/250ml (10mcg/ml) Bag?

The NDC package code 83343-002-15 was assigned to a 5447 mL in 1 VIAL of administered intravenous via injection, solution.

Who manufactures this product?

Fentanyl Citrate 2500mcg/250ml (10mcg/ml) Bag is manufactured by an outsourced facility and labeled by Mcguff Outsourcing Solutions 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.

Which are the NDC crossover matchings for this product?

We found 30 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by Hybrid Pharma, BPI Labs LLC and Medi-Fare Drug with NDC product codes 26436-5002-1, 26436-5002-1, 26436-5055-3, 26436-5055-3, 26436-5084-3, 26436-5084-3, 26436-5084-3, 26436-5194-3, 26436-5194-3, 26436-5472-5, 26436-5558-0, 26436-5558-0, 26436-5558-5, 26436-5558-5, 26436-5558-5, 26436-5575-3, 26436-5575-3, 26436-5576-3, 26436-5576-3, 26436-5580-1, 26436-5580-1, 26436-5580-1, 26436-5589-3, 26436-5589-3, 26436-6000-1, 26436-6001-1, 26436-6018-1, 54288-821-01, 61141-1137-4 and 61141-1318-1.