When a US company has a drug product that is approved in the US and a foreign country, do they need to assign NDC codes to the foreign/exported product configurations and do those products need to be listed with the US product in eDRLS? If so, are they listed in the same SPL or a separate SPL? If in the same SPL, are there any SPL elements that indicate the specific NDC codes are exported product? Is there any other guidance or helpful tips you can provide for this scenario?
Thank you
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Robyn Walsh
Regulatory Affairs, Associate Director
Danbury CT
United States
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