NDC Labeler Code Requests

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 select the Labelers tab:

• Click to select an existing Labeler from the available list to load the Labeler's “Labeler Detail” page
  or
• Click the Create New Labeler link to create a new Labeler/add a Labeler Code to the account.

“Labeler Detail” page:

Clicking the NDC Labeler Code Files link opens a new window displaying any previously created NDC Labeler Code file records and a form to create additional NDC Labeler Code files. 

1. Existing NDC labeler code submissions are listed in descending order based on the version number.
2. Click the “Create NDC Labeler Code Request” button to create a new NDC Labeler Code submission. Make sure to populate the Request Type and Effective Date before creating a new version.
   
3. An SPL file will be created and made available under the download section.  The Version number is incremented automatically.
4. Click the "Create SPL Review File" button to create a NDC Labeler Code review file to proof your file’s content. Please note that Review files are not saved in SPL Portal, but will be downloaded to your computer automatically. Please save the Review file on your computer for future reference.
5. The files Version Number(Version No:) is automatically incremented by SPL Portal.

An explanation of the data elements in this page is included below: