NDC Registration

The compliance experts at Quality Smart Solutions can help you with NDC Labeler Code registration. Our experts will assist you in preparing and submitting a request in SPL (Structured Product Labeling)  via ESG or the FDA’s CDER Direct Portal for NDC registration and enable you to sell your drug 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 drug products. The first segment of the code assigned by FDA represents the establishment. The second and third segments are assigned by the labeler of the product. As a drug establishment, you need to provide the FDA with a current list of all drugs manufactured, packaged, prepared, compounded or processed for sale in the US at your facility. 

The Food and Drug Administration strives to publish the listed NDC numbers in the NDC Directory which is updated daily. To obtain an NDC Labeler code, the labeler is required to prepare and submit an “NDC Labeler Code Request” to the FDA. Please note that the FDA accepts the request only via ESG or the FDA’s CDER Direct Portal.

What does an NDC Labeler Code Look Like?

Assume you have been assigned 54321 – 123 – 50 labeler 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

An example of an NDC Labeler Code could be “54321 – 123 – 50” for a 50 ml body lotion tube with active ingredient Glycerin 20% manufactured by ABC Company.

Frequently Asked Questions

NDC is an acronym for National Drug Code (NDC). It is a unique, three-segment 10 digit 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.

The US Food and Drug Administration (FDA) strives to publish the listed NDC numbers in the NDC Directory which is updated daily. To obtain the NDC Labeler code, the labeler is required to prepare and submit an “NDC Labeler Code Request SPL” to the FDA. Please note that the FDA accepts the request only via ESG or CDER Direct Portal.

Where can I find an NDC number for my drug?

The bar code, or Universal Product Code (UPC) symbol is the series of black vertical lines seen on any Point-of-Sale product. On the other hand, a National Drug Code (NDC) number is a unique three-segment 10-digit number, with part of the number assigned by the FDA. NDC numbers apply to drugs only, whereas UPC numbers would apply to any product that is made available to consumers.

The first 5 numbers are used to identify the drug manufacturer.  The 4 numbers in the middle are used to identify the drug itself.  Finally, the last 2 numbers are used to identify the packaging.

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