Geoff LeCain

  Users can create a new product by clicking the Create New Product link on the Product List tab of the Products page. The Product Detail page is displayed with various fields.  The application w...

The “Labelers” tab displays all Labelers that are associated with products in the data repository.  This tab also provides users with the ability to generate NDC Labeler Code submissions. To edit...

The “Company Configuration “tab allows company administrators to define company specific options such as: Company Name –Define the name of the company which appears on the main screen Invalid Logi...

Answer: No, the files will always be available to download from the Portal.

Labelers and NDC Labeler Code files are managed under the Labeler Tab of the Contacts/Entities page:  Click to select the Contacts/Entities button to load the Contacts/Entities page, then click to ...

The “labeling types” tab allows company administrator to designate what labeling types users can select from in the application. The application offers several labeling types.  Select the types th...

Answer: The term “Pass Validation” refers to a submission that has successfully been loaded into the FDA’s system. When a submission file has errors that do not allow for it to upload into the FDA’...

The application allows for the generation of a new REMS Set ID. The “Generate New REMS Set ID” button should only be used in rare circumstances when a new SetID needs to be created. Previously ele...

The “View Associated Product Listings” link is used to view all products in the data repository associated with the specific labeler.

The “submission type” tab allows company administrator to define company specific submission types. Submission types are used for reporting purposes only. Some examples of commonly used submission ...