Part of the FDA’s requirement to electronically list drug products (Rx and OTC) includes the assignment of a National Drug Code (NDC). An NDC is a 10 digit number that uniquely identifies a drug product by stringing together three separate code segments. A complete NDC is made up of a labeler code, a product code and package code segment, with dashes between each segment.
NDCs are configured in either 5-3-2 or 5-4-1 formats. While 5-3-2 is the most common format selected by labelers, some companies with large product portfolios find that 5-4-1 works better for them, since it allows for ten times the number of product codes as 5-3-2. 5-4-1 does, however, limit the number of available package codes per product to ten (0-9).
It is important to note that a labeler must select and stick with one or the other of these formats. FDA does not allow switching back and forth between 5-3-2 and 5-4-1 based on what is convenient for each product. Labelers should consider carefully not only their current product portfolios and packaging configurations but also any plans for future product offerings when selecting a format.
First Segment – The Labeler Code
The NDC Labeler Code makes up the first segment of the complete NDC. A Labeler Code is five digits (with some exceptions for earlier codes, which may be only four) and identifies the company responsible for distributing the product in the United States. The Labeler Code is the only portion of the NDC which is assigned by FDA. The remaining portions are assigned by the labeler company and then registered with FDA through the electronic drug listing process. To obtain a labeler code, you must submit an electronic NDC Labeler Code Request to the FDA.
In our fictitious NDC example above, the labeler code is 12345. The code would have a labeler name associated with it in the FDA’s database—Acme Medicine Co., for instance. All Acme product NDCs would begin with labeler code 12345.
The product code segment identifies the specific product in question. For example, a 200mg coated ibuprofen tablet from the same labeler would be identified by the same product code in all of its packaging configurations. So, in the example above, NDC 12345-123 could signify a 200mg coated ibuprofen tablet distributed by Acme Medicine. If Acme had a variation of this product with a different attribute (e.g., a 200mg ibuprofen liquid capsule), it would receive a separate product code (e.g., 12345-124).
Third Segment – The Package Code
The final segment of an NDC is the package code. The package code identifies in what configuration the product is offered for sale. For instance, NDC 12345-123-01 may identify Acme’s 200mg, film-coated ibuprofen tablet, distributed in a bottle of 25 tablets. NDC 12345-123-02 may signify a bottle of 100 of the same tablets.
Important as they are, NDCs are just a small component of FDA’s electronic drug listing process. The information above is only the basics and you may have many questions about assigning NDCs to your drug products and electronically listing them. Reed Tech has been helping drug product labelers and manufacturers from the earliest days of electronic drug listing. Feel free to contact us and one of our experts will be glad to help.