NDC is an acronym for National Drug Code (NDC). It is a unique, three-segment 10 digits number used to identify drugs. The first segment of the code assigned by FDA represents the establishment. The second and third segments are assigned by the labeler. As a drug establishment, you need to provide FDA with a current list of all drugs manufactured, propagated, prepared compounded or processed for sale in the US at your facility.
Food and Drug Administration strives to publish the listed NDC numbers in the NDC Directory which is updated daily. For getting the NDC Labeler code, the labeler is required to prepare and submit an “NDC Labeler Code Request SPL” to FDA. Please note that FDA accepts the request only via ESG or CDER Direct Portal.