How to List a Drug
All registered establishments must list every drug they produce for U.S. commercial distribution under their own labeler code. A labeler code must be assigned prior to listing submission to FDA.
A drug listing structured product labeling (SPL) may include multiple national drug codes (NDCs) (on the drug products and packages) provided they all use the same content of labeling.
Required data elements to list a drug
When creating a drug listing, include:
- Full proposed NDC (visit NDC format for more information)
- Proprietary and non-proprietary name
- If a drug does not have a proprietary name, the established name of the drug should be included in the proprietary name field
- Dosage form and route of administration
- The name with unique ingredient identifier code and amount/strength (with appropriate unit of measure such as grams, milliliters, etc.) of each active ingredient
- Active ingredient strength sometimes has to be converted to SPL acceptable values (visit strength conversion in drug listing for more information)
- Each inactive ingredient (name and unique ingredient identifier code)
- The amount/strength of each inactive ingredient may be included
- A copy of the most up-to-date labeling, including a .jpg file of the outer packaging and principal display panel of each drug product in the SPL submission
- The name and Data Universal Numbering System (DUNS) number for each establishment involved in manufacturing the product
When to list a drug
Initial drug listings should be submitted within three days after initial registration of the establishment. Update the listing information as soon as possible after any changes occur. All updates must be made no later than the following June or December.
An establishment may submit a blanket no changes certification once per year during the October 1 to December 31 renewal period for drugs that do not require any updates.
Steps to list a drug
- Select the appropriate SPL document type for the product (human prescription drug, human over-the-counter/nonprescription drug, bulk ingredient, etc.)
- Fill out all required listing data elements
- Create a section within the SPL file for each section of content for labeling (e.g., highlights, warnings, how supplied) and enter the text for each
- The .jpg file(s) of the outer packaging/front label belongs in the package label.principal display panel section
- Submit SPL
Visit instructions to list a human drug using FDA Direct (page three) for more information.
Updates to drug listing
- Create a copy/new version of the most recent submission
- Do not change the set ID
- Generate a new document ID/root ID
- Enter an appropriate effective date and version number (generally, one number higher than the previous submission)
- Modify all listing data and labeling as appropriate
- Submit SPL
Blanket no change certification for drug listing data
Every year, an establishment must either update its drug listings or certify that no changes have occurred. This applies to drugs that were not listed or updated during the current calendar year. An establishment can submit a no-change certification between October 1 and December 31.
Every January, FDA inactivates any human drug listings that were not certified during the October 1 to December 31 renewal period. Inactivated listings are removed from the NDC directory and other listing publications.
Visit instructions to submit a blanket no change certification for product listing using FDA Direct (page three) for more information.