Dietary supplement NDC Number

NDC Number is a 10-digit number, assigned only for drugs (FDA assign the first 5 digits which is for the labeler). Dietary supplements are not supposed to assign NDC number, even though a physician prescribes it. Printing NDC number on dietary supplement label to get medical reimbursement is prohibited and may consider as misbranded.

Dietary supplement comes under FDA food regulations, FDA published specific labeling guidance for dietary supplements. Dietary supplements must have food facility registration, GMP and label compliance to market in the USA.

NDC Number on Medical foods

Medical foods are special foods formulated to consumed under the supervision of a physician, which is intended for specific dietary needs. FDA regulate medical foods as food. Medical foods should not use NDC number on its labeling. It must comply with FDA food labeling regulations.

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