All registered establishments must list all drugs they produce for U.S. commercial distribution under their own labeler code. This includes active pharmaceutical ingredient manufacturers, other bulk drug manufacturers, contract manufacturers, repacks and relabeler. A single product listing (SPL) may include multiple NDCs (products and packages) provided that they all use the same content of labeling/package insert.
2 to 5 business days
Add to cart & pay service fees
Fill out the form on the website after checkout
Get your form reviewed by our experts. (We will contact you if needed)
Receive your certificate for registration