The custom of NDC or National Drug Code identification number knows no leaps and bounds in the pharmaceutical industry of the United States. This patented code usually appears on all nonprescription (OTC) and prescription medication packages and inserts in the US. The breakdown of three segments of the NDC includes a labeler, the product, and the commercial package size. The first segment, the labeler code, is allotted by the FDA. A labeler is identified as one that manufactures (including repackers or relabelers), or distributes (under its name) the drug. The second segment is called the product code, identifies a specific strength, dosage form, and formulation for a particular firm. The third and the last segment, the package code, identifies package sizes and types. The firm allocates these product and package codes.
The NDC format looks like this: 4-4-2, 5-3-2, or 5-4-1.
Over the years, we have to come to realize that the pharmaceutical supply chain and the pharmacy profession’s operations are heavily dependent on this 10- or 11-digit NDC number.
As a shopper of medicines, you hardly have known this part that every step in pharmaceutical product manufacturing, distribution, and pharmacy operation utilizes the NDC code. However, recently, the Food and Drug Administration (FDA) is facing a serious shortage of NDC numbers and so plans to restructure the code format for better access.
NDC Use
NDC code has many relevant uses on a widespread basis. It supports the mountain of functions such as:
NDC code has many relevant uses on a widespread basis. It supports the mountain of functions such as:
- NDC assignment to a new drug product and its visibility on the product’s label
- Pharmaceutical distribution systems
- FDA product approval systems and the NDC product directory
- All item-level databases that withstand health information systems
- Any drug information or clinical information system
- E-prescribing platforms
- Pharmacy dispensing/workflow systems and labeling provided to the consumer
- Pharmacy inventory systems and shelf placement methods
- Immunization and other product registries
- Medication error reporting systems, including the FDA and private sector
- Returned goods systems
FDA To Implement Essential Steps
Back in 2018, the FDA became proactive on seeking input on the NDC number’s future format. As of today, it’s worried about the new format of the NDC number. The FDA is seeking feedback from the stakeholder on the following topics:
- The impact of switching over from a 5-digit labeler code to 6-digit labeler code, including the business, financial, information technology, and medical/clinical practice impacts, and its projected impact on the safety and security of drug products as well.
- Issues related to the current lack of NDC uniformity in the marketplace
- How can the FDA brings any decent changes to the format or length of the NDC?
