The National Drug Code (NDC) identifies a drug in US commercial distribution. The labeler code identifies the company marketing it; establishment registration addresses the facilities that manufacture, repack, relabel, or salvage drugs. These are related but distinct duties. A private-label distributor with no registrable establishment activity does not automatically need its own establishment registration.
Current and future NDC formats
FDA currently assigns 10-digit NDCs in 4-4-2, 5-3-2, or 5-4-1 configurations. Thus FDA-assigned NDCs currently have four- or five-digit labeler segments. 21 CFR 207.33 also permits eleven-digit NDC configurations with a six-digit labeler segment; FDA says it will issue these when five-digit codes are exhausted. The 11-digit format used for HIPAA reimbursement is a separate conversion; it is not the FDA-assigned identifier. FDA's uniform 12-digit, 6-4-2 format takes effect March 7, 2033, and should not be presented as already in force.
Requesting and confirming a labeler code
The marketing company submits a labeler-code request in Structured Product Labeling (SPL) format with company and contact data, including its DUNS number. FDA assigns a labeler code after review. The company then submits an updated labeler-code SPL with that assigned number to complete confirmation. FDA says no drugs may be listed under the code until that second step is complete. A manufacturer with multiple establishments does not need a separate code for each establishment.
Listing and maintaining a drug
Drug listing is a separate SPL submission with the proposed NDC, product details, labeling, packaging, and the establishments involved. Establishments carrying out registrable activities have their own registration duties. Under 21 CFR 207.57, registrants review and update listings in June and December, submit applicable changes, and certify unchanged listings. FDA encourages prompt updates when changes occur. The 30-day labeler-information update rule is separate. A listed NDC does not constitute FDA approval.
Choose the relevant FDABridge service
The $249 NDC Labeler Code service covers the request and confirmation for an eligible marketing company. The $149 per-product Drug Listing service covers the separate listing submission. A facility that actually requires establishment registration can discuss the $499 registration service or the relevant setup offer. We assess the roles and existing records before recommending a bundle; FEI acquisition or a $799 setup package is not a universal prerequisite for a standalone labeler-code request.
What Is an NDC Number and How Foreign Drug Manufacturers Obtain One
Understand the marketing company’s labeler code, FDA’s current NDC format, the confirmation SPL, and the separate establishment and product-listing duties.