OTC drug Listing and 10-digit NDC Labeler Code

OTC drug listing and 10-digit NDC Labeler code assignment are the next steps after establishment registration. Over the counter drugs or OTC drugs are products/drugs that are available without a prescription. The establishment is required to submit all drug information in a Structured Product Labeling (SPL) format, the listing also involves submitting a product label.

 

Once the OTC drug listing is submitted a 10-digit NDC Labeler Code is provided. The National Drug Code (NDC) is a unique 10-digit code. It is segmented into 3 parts: the first set consisting of the first 5 digits identifies the labeler (manufacturer, labeler etc.) and is assigned by the FDA, the second set of the next three numbers is the product code identifying the strength, dosage and formulation of the drug and is assigned by the labeler, the third set of the last two digits is the packaging code, identifying the packaging sizes and is also assigned by the labeler.