FDA NDC, Drug Establishment Registration and Drug Listing Support

Support for drug establishment registration, labeler code, NDC and SPL drug listing for applicable manufacturers, repackers and relabelers, with a clear distinction between listing and FDA approval.

Service overview

U.S. drug establishment registration, labeler code and drug listing are related but distinct submissions. The NDC identifies listed drugs; assignment of an NDC and drug listing do not mean FDA approval and NDCs must not be assigned to non-drug products. SCS Testing supports establishment-role assessment, SPL data preparation and label/record reconciliation. New drug, generic drug or other marketing-authorization pathways require separate assessment.

Applicable products or businesses

• Applicable establishments manufacturing, preparing, propagating, compounding, repacking or relabelling drugs for U.S. commercial distribution
• Projects requiring establishment registration, labeler code, NDC or drug-listing maintenance
• Businesses reconciling labels, SPL and existing NDC Directory records

Target market

• U.S. drug market

Regulatory authority

• FDA Center for Drug Evaluation and Research or another applicable FDA center

Regulations, directives and standards

• FD&C Act section 510 drug establishment registration and listing
• 21 CFR Part 207 drug registration and listing
• FDA eDRLS, SPL and NDC format/labelling guidance
• Applicable drug marketing-authorization law, separate from listing
• FDA's uniform 12-digit NDC format takes effect on March 7, 2033; current 10-digit assignment and listing rules continue during the transition

Service scope

• Initial drug-status and establishment-activity assessment
• Establishment registration, FEI and labeler-code data reconciliation
• NDC structure, SPL drug listing and label-information preparation
• Annual registration, semiannual updates/changes and no-change certification support

Service process

• Confirm drug status, legal marketing basis and establishment activities
• Reconcile legal entity, FEI, establishment registration and labeler code
• Compile formulation, dosage form, strength, packaging and label data
• Create and validate SPL registration/listing submissions
• Maintain annual registration, listing updates and label consistency

Information required

• Legal establishment name, address, FEI and activity type
• Labeler code and existing registration/listing information
• Drug ingredients, dosage form, strength, package sizes and marketing status
• Complete label, proprietary name, application number or legal marketing basis
• SPL SetID/DocumentID and historical submissions where available

## Reports, certificates or registration outcomes Outputs may include establishment registration, labeler-code and SPL drug-listing support and NDC record reconciliation. FDA states that establishment registration, drug listing or NDC assignment does not mean company or product approval; the drug must have an appropriate legal marketing basis.

Factors affecting timing

Timing depends on drug status and legal marketing basis, establishment/FEI matching, labeler code, label data, SPL validation and FDA feedback. NDC format transitions must follow the current FDA implementation schedule.

Common compliance risks

• Assigning or promoting an NDC for a non-drug product
• Using an NDC or listing as evidence of FDA approval
• Incorrect relationships among establishment registration, labeler code and listing entities
• SPL, labels, package sizes and NDC Directory records are inconsistent
• Applying the 2033 format prematurely to current listings or presenting the format change as product approval

Related services

• FDA FEI information support
• Drug label and SPL reconciliation
• Initial U.S. drug marketing-pathway review
• FDA establishment registration maintenance

Information for an initial assessment

Provide the product name, model, intended use, target market, bill of materials and available reports so that the applicable route and evidence gaps can be assessed.