With the Food and Drug Administration Amendments Act of 2007 (Public Law 110-85) (FDAAA), electronic submission is now required unless a waiver is granted. To facilitate the submission of drug establishment registration and drug listing information (including labeling as specified under 21 CFR 207.25), FDA adopted the use of Extensible Markup Language (XML) files in the Structured Product Labeling (SPL) format. To transmit the SPL formatted submission, firms must use the FDA’s Electronic Submission Gateway (ESG).
In order to complete an SPL submission, it is necessary to include firm’s DUNS number. For more information visit: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162544.htm.
- CDER Direct is now available for Registration and Listing! See below for description.
- Human Drug Compounding Registration And Product Reporting Procedures
- FDA has stopped issuing National Health Related Items Code (NHRIC) and National Drug Code (NDC) labeler codes to manufacturers for use with medical devices. Under 21 CFR 801.57, after the date the device must bear a unique device identifier (UDI) on its label or on September 24, 2018 if the device is not required to bear a UDI on its label, any NHRIC or NDC number assigned to a device is rescinded and may no longer be on the label. A labeler may continue to use an NHRIC or NDC labeler code under a system for the issuance of UDIs if the labeler submits a request for continued use of the labeler code to FDA by September 24, 2014 and receives approval for continued use. To receive instructions for requesting continued use of an NHRIC or NDC labeler code, please submit a question at the UDI help desk: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ucm368904.htm
SPL files including all image files are then placed in a folder and sent through the ESG. The name of the “center” and the “type of submission” are used to properly route the files. For electronic drug registration and listing, the center is “OC” and the type of submission is “SPL”.
Electronic Submissions Gateway
Verify Submission Status
- CVM products: AskCVM@fda.hhs.gov
- CBER products: CBERSPL@fda.hhs.gov
- CDER products: eDRLS@fda.hhs.gov.
Labeler Code Request:
To request a new labeler code for your company for use in NDCs, submit a labeler code request SPL file with the NDC Labeler Code field left blank. Once all the requested information is provided, allow 30 days to receive the assignment notification via email to the contact email address in the request. To check the status after 30 days, you can send an email to: eDRLS@fda.hhs.gov.
To apply for a waiver from the requirement to electronically submit drug establishment registration and drug listing information, provide a written request with a complete explanation of why use of electronic means is not reasonable for you. Submit the request to:
U.S. Food and Drug Administration (HFD-001)
- Introduction to eDRLS
National Drug Code Directory NDC Product File Definitions NDC Package File Definitions Drug Establishments Current Registration Site
- Regulatory Guidance: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (PDF - 103KB)
Structured Product Labeling Resources Electronic Submissions Gateway Xforms