Get Preparing Electronic Ndc Labeler Code And Drug Establishment ... - Fda

This guide provides clear instructions for filling out the Preparing Electronic NDC Labeler Code and Drug Establishment Registration form. It aims to assist users of all experience levels in successfully completing this online submission.

Follow the steps to accurately complete the form.

1. Press the ‘Get Form’ button to access the form and open it for completion.
2. Select a template from the drop-down menu based on the type of SPL you wish to create and click ‘Load Template’.
3. Check the auto-populated fields that appear on opening the form, including Document ID, Effective Time, Version, and Set ID. Typically, you will not need to change this information unless updating.
4. Enter the labeler’s name, which should be the name of the registrant or private label distributor requesting the NDC Labeler Code.
5. Input the labeler’s DUNS number without hyphens or spaces before or after the number.
6. If you have an assigned NDC Labeler Code, input it. If not, clear the field for NDC Labeler Code.
7. Complete the contact person’s information including first name, last name, street address, city, state, country code, postal code, telephone number, and email address. Ensure there are no unintended spaces.
8. Review all entries for accuracy. Utilize the ‘Save In’ button to ensure all changes are saved to the correct file location.
9. Once saved, confirm that you receive a message indicating successful data storage. If necessary, you can then use the ‘Save’ button for further updates.
10. After completing the form, you may download, print, or share it as required.

Complete your NDC Labeler Code and Drug Establishment Registration online today!