There are three essential factors that need to be considered when deciding whether a new NDC number needs to be filed for a product:
1. Whether the label is different
2. Whether the formulation is different
3. Whether the packaging is different
If any of these three elements changes, then this will trigger the need for new NDC numbering codes for a given product.
Simply put, if the same product formulation is put into several different packaging sizes then this will trigger a new number. If different formulations are put into the same size packaging it will require a new NDC number AND if different formulations are used in the same size packaging this will require a new NDC number.
Clearly if a formulation changes, this will also trigger a new label too, but the point here is to recognize that these individual categories are individual triggers for new numbers and a regulatory filing. Contact us if you need assistance with this process.
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