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National Drug Code (“NDC”)

The NDC is a unique number made up of three distinct segments. The first portion is the labeler code. All drug manufacturers or repackagers are required to register with the FDA. The first segment of this unique 11-digit number is assigned by the FDA to each registrant. The second and third segments of this number are related to the product identity and package size or type. The manufacturers are allowed to assign whatever numbers they wish for each product and package configuration, but they must conform to the established format and must provide to the FDA all the required all information relating to that specific product. This knowing failure to list an NDC with the FDA is fraud. Although it has rarely if ever historically been enforced.

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