Structured Product Labeling Workbooks

The following workbooks help us convert your pharma information into the SPL format. Please select the appropriate workbook based on conversation with your DCL project manager. You can save a copy of the workbook to your local environment and then submit back to DCL.

Prescription Drugs

Structured Product Labeling

This is the core workbook, designed for the SPL filings. There is a tab for each type of file:

  • Generic Self-Identification

  • Establishment Registration

  • NDC Labeler Code

  • Drug listings

Filling Out Prescriptions

Blanket No Change Certification

The Blanket No Change Certification (BNCC) workbook is convenient and easy to create, but not without validation complexity.

There is just one tab for users to fill out and return to DCL.

Sorting Medicine

Lot Distribution

Report

Applicants must submit Lot Distribution Reports (LDRs) containing certain specified information every 6 months.

 

There is one tab for users to fill out and return to DCL.