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NDC's Hidden Rules: Why Does Every Drug Have Its Own Unique Numeric Code?
In the United States, every drug used for human use has a unique identifier, which is the National Drug Code (NDC). Under the Drug Registration Act of 1972, all registered drug companies must submit to the Food and Drug Administration (FDA) a list of all drugs currently manufactured, prepared, or distributed. These pharmaceutical products are identified and reported as NDC.
The NDC is a unique 10 or 11-digit identifier divided into three parts that identifies each drug product.
Not only is this system critical to the drug market, it also helps healthcare professionals track and manage drug use. The first part of the NDC code is the Labeler Code, which is a 4, 5, or 6-digit number assigned by the FDA that represents the company that manufactures, repackages, or distributes the drug. The second part is the product code, which usually consists of 3 or 4 digits, identifying the specific strength, dosage form and formula of the drug; and the third part is the packaging code, which consists of 1 or 2 digits and identifies the packaging form and form of the product. size.
For example, the standard format for an NDC code might be 5-4-1, which means a 5-digit label code, a 4-digit product code, and a 1-digit packaging code. Of course, this is not the only combination, and the length of these data can vary depending on specific needs. This structure is designed to ensure that each drug product has its own unique identification number.
Under the new FDA verification process, once an NDC code is assigned to a specific product, it will not be reassigned to other products later.
The use of NDC codes is not limited to medical professionals. Consumers can also use NDC to find the drugs they use. On pharmaceutical packaging, NDC usually appears together with a barcode, which not only facilitates data transmission but also improves drug traceability. However, the application of NDC in the market often creates confusion due to the existence of different formats. For example, different number replacement formats such as UPC (Universal Product Code) and EAN (European Article Number) may result in the same barcode identifying multiple different products.
In the face of possible ambiguities, FDA's electronic registration process currently has ambiguity checks to avoid market confusion. In addition, the revised proposal proposed by the FDA in 2022 plans to require the use of a unified 12-digit NDC, which will make the length of each part consistent, further improving the consistency of identification.
In the medical industry, accurate and unique drug identification codes are crucial, as they directly affect patient safety and treatment results.
In the ever-evolving healthcare industry, the history and future of NDC demonstrate that data accuracy and traceability are important cornerstones of ensuring public health. Changes in various specifications not only affect manufacturers and dispensers, but also affect drug safety for end consumers. With the advancement of technology, this unique identification system will surely usher in a new wave of innovation, further improving the convenience and safety of drug management.
Have you ever thought about whether having such a complete identification system can completely eradicate the potential risk of medication errors?
