NDC Code Reservations / Reserved Marketing Status

For Human and Animal Drugs and certain Biological products, NDC Code Reservation SPLs may be submitted to the FDA to reserve an NDC Manufactured Product Code for future use. NDC Code Reservation SPLs do not require any Content of Labeling sections.

NDC Reservation SPL documents must include:

• a Dosage Form(Form Code)
• a Non-Proprietary Name(Established Name)
• a Marketing Status(Reserved - new/Reserved - cancelled)
• a Marketing Start Date(up to 2 years in the future)
• at least one Active Ingredient:
  • Basis of Strength
  • Active Ingredient Name & UNII
  • the Active Ingredient’s strength description (Numerator & Denominator Units, i.e. 100 MG/1 Tablet)
  • Active Moiety

A Proprietary Name is not required. Packaging is also not required.

After creating a new Product by clicking the “Create New Product” link on the Products page, click the “Product Data Elements” button and then click the “New Manufactured Product” link to load the form to create a new Manufactured Product. Populate and Save the form fields with the Product’s Form Code, Established Name, Marketing Status(Reserved – new), and Marketing Start Date. 

To cancel a previously Reserved NDC, change the Marketing Status to "Reserved - cancelled", do not add a Marketing End Date and then click the Save button.

After this information has been saved to the form, click to select the Active Ingredient tab to populate and save the Product’s Active Ingredient information.

Next, click to select the Product’s “Content Editor” button. The product's Content Editor page will load. On the Content Editor page select the Product’s anticipated Labeling Type from the “1. FDA Labeling Type” drop-down menu, select the associated Labeling Template from the “1A. Choose a template” drop-down menu, and then click the “Checkout and Create Draft” button to load the template for the Product’s Labeling.

As Content of Labeling sections are not required for NDC Code Reservation SPLs, the sections of the template can be deleted via the “Delete Section” button.

Alternatively, a Labeling Template without Sections could be created under the “Templates” page, allowing for a “blank” Labeling Template to be available under the “1A. Choose a template” drop-down menu.

Finally, to generate the NDC Code Reservation SPL file select the “Create SPL for FDA Submission” option listed under the “Create SPL” drop-down menu.

After doing so the “Create SPL Submission” window will open on the page displaying a “Create” button to generate the SPL file for download.