NDC Registration

We are a one-stop place for NDC Labeler Code registration. Our experts will assist you in preparing and submitting a request in SPL (Structured Product Labeling)  via ESG or CDER Direct Portal for NDC registration and enable you to sell your products in the US market. 

What is an NDC Number?

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 labeller. 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 labeller is required to prepare and submit an “NDC Labeller Code Request SPL” to FDA. Please note that FDA accepts the request only via ESG or CDER Direct Portal.

Example of NDC Labeller Code Assignment

Assume you have been assigned 54321 – 123 – 50 labeller code for 50 ml body lotion tube with active ingredient Glycerin 20% manufactured by ABC Company.

Labeller

54321

ABC Company

Drug

123

body lotion Glycerin 20%

Package

50

50ml Tube

In this example, the first segment of label code "54321" identifies the Manufacturer - ABC Company. The second segment "123" identifies the Drug - Body lotion with active ingredient Glycerin 20%. The third segment "50" catalogues the package type and size - 50 ml tube.
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