Establishment Registration

You are just a few clicks away from compliance. After you sign into our website, you can send your Establishment Registration to the Food and Drug Administration (FDA) through the Electronic Submission Gateway (ESG).

Repackager SPL (RSPL)

With just a few pieces of information (i.e. Your NDC, Manufacturer NDC, Package Sizes and a picture of the Label), our web app can produce a Structure Product Label (SPL) file that is ready to be sent to the FDA. Other services include National Drug Code Registration and Request.

1 FDA Registration
2 Drug Listing
3 Establishment

What's New?

Who needs RSPL

Repackager and Relabelers of any drug sold in the United State of America must send the Drug Product Listing in SPL format to the FDA using the Electronic Submission Gateway. Using RSPL you can generate the necessary files with one click.

How to use RSPL

Three simple steps are necessary to generate the SPL file.
  • Enter Company Information: Company Name, Address, DUNS and Contact Information.
  • Product Information: Labeler Code, Original or Source NDC, Company NDC, Size, Package Form and Label Image.
  • Generate SPL File with a click.

SPL Genie will gather all the necessary information and produce a valid SPL file. Once reviewed you can send it to the FDA using our Electronic Submission Gateway AS2 Server (No FDA account needed).