Drug Registration and Listing Instructions
There are three types of submissions needed to register an establishment and list a drug with FDA. Each of these steps requires an initial submission followed by periodic updates to maintain current and accurate status:
- Establishment registration
- Labeler code request
- Drug listing
Additionally, applicants may reserve a National Drug Code up to two years prior to launching a drug.
FDA requires all registration and listing submissions to be in structured product labeling (SPL) format, using extensible markup language (XML) files. Submissions must comply with FDA validation rules to ensure accuracy and consistency. To create and submit SPL files, users may use one of the following: All SPL submissions except those submitted via FDA Direct and Xforms, must be submitted through the Electronic Submissions Gateway Next Generation (ESG NextGen) | FDA.
