Type II Drug Master File Guide Section "A" - DRUG ESTABLISHMENT REGISTRATION NUMBER

Type 2 DMF Guide

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A. DRUG ESTABLISHMENT REGISTRATION NUMBER

This is a number assigned to your company. Betterchem completes the proper forms and submits to the FDA. FDA will assign you a "Labeler Code Number" (LCN). Your LCN is specific to your company and does not change.

Each product, when registered with the FDA, will be given a "Product Code Number" (PCN). For each product, the PCN is different.

Together, the LCN and PCN form the "National Drug Code" (NDC) number. The NDC number is used by U.S. Customs to confirm that your product is registered with FDA.

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