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good morning my name is don duggan and im with the help desk operations team and with durless and cedar im going to be talking about labeler code requests today so we have some learning objectives were going to talk about who needs a labeler code and when should a firm apply for a labeler code were going to talk about the steps required to obtain a labeler code and also why its important to confirm the labeler code so what is the labeler code process well a manufacturer or private label distributor requests a labeler code from the fda using cedar direct the fda will go ahead and receive that submission we will process it manually and then well send an email with the assigned labeler code number and confirmation instructions back to the firm then the firm will go ahead and send back a confirmation labeler code which is really just a a labeler code request with the same set id a different root id the version number is one higher than the last accepted submission and they fill in t