Electronic Drug Registration and Listing Instructions

There are three steps, or submissions, that are 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 an accurate and current status:

1. Establishment registration

2. Labeler code

3. Drug product listing(s)

FDA has adopted extensible markup language (XML) files in the structured product labeling (SPL) format for users to submit registration and listing data. Users may transmit the SPL-formatted submission through FDA’s electronic submission gateway (ESG).

Tools for registration and listing submissions

Any SPL authoring software may be used to create registration and listing SPL files including CDER Direct and Xforms. Xforms and other third-party tools used to create SPL files require the creation of a FDA WebTrader account in order to submit the files. All registration and listing submissions, regardless of the source and tool used to create and submit, must pass the same rigorous set of validation rules.

Do I need to register?

Any establishment, with certain exemptions, engaged in manufacturing, repacking, relabeling or salvaging drug products for U.S. distribution is required to register with FDA. Some exemptions include:

• Pharmacies that:

• Operate in conformance with local laws regulating the practice of pharmacy and medicine

• Regularly engage in dispensing prescription drugs to fill patients’ prescriptions

• Do not manufacture, repack, relabel or salvage drugs other than in the regular course of their business of dispensing or selling drugs at retail

• Hospitals, clinics, other health care entities and public health agencies that:

• Operate establishments in conformance with all applicable local laws regulating the practice of pharmacy and medicine

• Regularly engage in dispensing prescription drugs upon a valid order or prescription

• Do not manufacture, repack, relabel or salvage drugs other than in the regular course of their practice of pharmacy, including dispensing

• Licensed practitioners who prescribe or administer drugs and who manufacture, repack, relabel or salvage drugs for use only in their professional practice

• Companies or individuals that manufacture, repack, relabel or salvage drugs solely for use in research, teaching or chemical analysis and not for sale

• Manufacturers, repackers and relabelers of certain inactive ingredients such as excipients, colorings, flavorings, emulsifiers, lubricants, preservatives or solvents that become components of drugs

• Carriers in their receipt, carriage, holding or delivery of drugs in their usual course of business

• Storage facilities that do not perform any manufacturing function

When to register?

Registration is required within five days of introducing drugs into commercial distribution. Annual registration renewal must occur between October 1 and December 31 each year.

Registration process

Create and submit an establishment registration SPL document to register with FDA. Be sure to save a copy of your submission. Remember to include:

• The name and Dun and Bradstreet verification, or Data Universal Numbering System (DUNS) number of the establishment (not one linked to the corporate headquarters)

• Contact information of someone responsible for receiving FDA communications related to that establishment

• All applicable business operations that establishment performs

• For foreign establishments, the name and DUNS of a U.S. agent and all importers

To renew, updated or deregister a registration: :

How do I renew a registration with no changes?   

• FDA is sharing training and additional resources below to assist in submission questions. 

• To submit No Change Notification using CDER Direct:

• Open the previously submitted and accepted Establishment Registration

• Click Create New Version

• Change the document type to No Change Notification

• Submit SPL. 

• To submit No Change Notification using other applications:

• Create a No Changes Notification Structured Product Labeling (SPL) document. 

• Fill in the SetID with the value from your previous or most recent submission 

• Enter the appropriate effective date and version number (generally, one number higher than the previous submission)

• Submit.  

How do I change establishment information in registration?

• FDA is sharing training and additional resources below to assist in submission questions.

• Please review all drug listing information and labeling.  

• To submit a change using CDER Direct: 

• Open the previously submitted and accepted Establishment Registration 

• Click Create New Version

• Enter the new address/DUNS or contact information that needs to be updated

• Submit Structured Product Labeling (SPL). 

• To submit a change using other applications: 

• Create a copy/new version of the most recent submission 

• Do not change the SetID. Retain the original SetID from the previous version

• Generate a new DocumentID/RootID

• Enter an appropriate effective date and version number (generally, one number higher than the previous submission) 

• Modify all establishment and contact information as appropriate and submit.  

How do I de-register?

• FDA is sharing training and additional resources below to assist in submission questions.

• To de-register using CDER Direct: 

• Open the previously submitted and accepted Establishment Registration

• Click Create New Version

• Change the document type to Establishment De-Registration and Submit SPL. 

• To de-register using another application: 

• Create an establishment deregistration SPL document. 

• Fill in the SetID with the SetID from your previous submission 

• Enter the appropriate effective date and version number (generally, one number higher than the previous submission)

• Submit.  

How do I know if my registration notification was successful? 

• Check the status of your registration at the Drug Establishment Current Registration Site (DECRS). Once your submission is successful, your firm’s name and information will appear with the expiration date of 12/31/2022 within 24 business hours.  

Do I need a labeler code?

Labeler codes are only used for generating National Drug Code (NDC) numbers for drugs. Generally, if you do not have to list any drugs with FDA, you do not need to apply for a labeler code. Under most circumstances, an assigned labeler code that does not have any NDCs listed with FDA within two years will be deactivated.

A company is not required to obtain a different labeler code for each manufacturing establishment under the same ownership since the labeler code identifies a company marketing a product.

Process for requesting a labeler code

• Create and submit a labeler code SPL document to request a new labeler code including all necessary data (e.g., name and DUNS number of the company, contact information of someone responsible for receiving FDA communications related to drug listings with NDCs under that labeler code)

• Leave the NDC labeler code field blank

• FDA will email the contact person on the request with the assigned number

• Submit an updated labeler code form SPL as described below with the newly assigned number filled in to complete the process

• To update labeler code information, including contact information and name changes of the company or changes in ownership of the labeler code:

Create a copy/new version of the most recent submission

Do not change the SetID

Generate a new DocumentID/RootID

Enter an appropriate effective date and version number (generally, one number higher than the previous submission)

Modify all establishment and contact information as appropriate

Submit

If a labeler code transfers to another company through a merger or acquisition, or if there’s a name change, all product listings under that labeler code must be updated with the new labeler name.

The new information captured in the labeler code request submission does not automatically populate or propagate to drug listing files under that labeler code.

Requesting Label Coder using CDER Direct

Listing

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, repackers and relabelers.

A single product listing SPL may include multiple NDCs (products and packages) provided that they all use the same content of labeling/package insert.

What data do I need to list a product?

When creating a product listing, be sure to include:

• Full 10-digit NDC

• 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 (UNII) 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 (see strength conversion in drug listing for more information)

• Each inactive ingredient (name and UNII)

• 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 DUNS number for each establishment involved in manufacturing the product

When do I list?

Initial drug listings should be submitted within three days after initial registration of the establishment. Updates to listing data are required to be made no later than June or December following a change in the information. However, FDA requests they be made as soon as possible.

A company may submit a single “blanket” no changes certification once a year during the October 1 to December 31 renewal period for products that do not require any updates.

Listing process

To list a product:

• Select the appropriate SPL document type for the product (human Rx drug, human OTC, 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 section entitled Package Label.Principal Display Panel

• Submit

• Product Listing using CDER Direct

Updates to listing

To update a listing:

• Create a copy/new version of the most recent submission

• Do not change the SetID

• Generate a new DocumentID/RootID

• Enter an appropriate effective date and version number (generally, one number higher than the previous submission)

• Modify all listing data elements and labeling as appropriate

• Submit

Blanket no change certification for product listing data 

There is an annual requirement to either update listings or certify that no changes have occurred for drugs that were not initially listed or updated during the current calendar year. The period for product listing certification is October 1 through December 31 each year.

Any drug listing that is required to be certified but is not certified may be considered inactive and removed from the NDC Directory and other publications of listing data. Outside this three-month window an update of the listing SPL submission for each NDC is required to certify the product.

Blanket No Changes Certification of Product Listing using CDER Direct 

Use of the National Drug Code

Drugs are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which serves as the FDA’s universal product identifier for drugs. NDCs should not be assigned to non-drug products such as medical devices and medical foods. Submission of NDC is required at the time of drug listing with FDA.

Registration of a drug establishment or drug wholesaler or assignment of a registration number or assignment of NDC number does not in any way denote approval of the company or its products. Any representation that creates an impression of official approval because of registration or possession of registration number or NDC number is misleading and violates federal law.

Related Links

• Introduction to eDRLS

• Product listing certification guide

• National Drug Code Directory

• Drug establishments current registration site

• Structured product labeling resources

• CDER direct

• Electronic submissions gateway

• Xforms