The FDA’s 12-digit NDC rule takes effect on March 7, 2033, with a transition through March 2036. Our earlier article, NDC-12 Regulation: Is your inspection system ready?, covers the rule and its impact on equipment in detail. This recap picks up from there with what our specialists Olivier Laboissonnière and Alexander Roth added in the live session: a data risk many teams overlook, a barcode decision for OTC, and how to size the work.

The shortcut that doesn’t fail, it lies

Because today’s 10-digit NDC sits inside the GTIN, many ERP, serialization and reporting systems never stored the NDC as its own field. They calculate it from digits 4 to 13 of the GTIN. Once 12-digit NDCs arrive, that calculation returns a number that looks valid but is wrong. There is no error and no alert, and the wrong NDC travels in your EPCIS files to every partner.

If you own the NDC, store both the 10- and 12-digit NDC in one product record, remove the shortcut from ERP, serialization and reports, and tell your CMOs before you switch. If you manufacture for others, take the NDC from your client’s record, never from the GTIN. Run each client on its own switch date, and write that into your quality agreements.

OTC: decide which barcode carries the NDC

The UPC-A cannot carry 12 digits. OTC manufacturers can keep the UPC and add a 2D code, move to a single 2D code, or use a longer linear code that supports the NDC field. Check three things first: whether your key retailers scan 2D, whether your smallest carton has room, and who prints the code. GS1 US’s Sunrise 2027 goal is for retail checkouts to read 2D codes by the end of 2027. It is an industry target, not a regulation. Confirm that any option you choose meets the FDA barcode rule for your product.

One SKU, four teams

Each NDC SKU involves four teams: packaging and regulatory (artwork), packaging engineering (line layouts), serialization and IT (data), and quality (validation). With 150 SKUs, that is roughly 600 pieces of work. Starting early gives you more budget cycles, planned shutdowns and chances to retest. As an illustration, the session compared six budget cycles with one. The FDA extended an earlier DSCSA deadline, and our speakers advised against building a plan on a repeat.

Your first 90 days

  • Days 1–30: answer seven questions. Does your code fit at 26×26, or is it already 32×32? Is every NDC reader a camera, not a laser? Is there room for a fifth text line? Does your line software support the new field? Do site records hold both formats? Is the NDC stored, never calculated from the GTIN? Are your EPCIS files and partners ready for both formats?
  • Days 31–60: size it. For each “no”, estimate the SKUs, lines, equipment, systems and partners involved.
  • Days 61–90: list your needs. Build one list, ranked by size and lead time, with an owner for each item.

Most teams will answer “no” to most questions today, and that is a normal starting point.

Questions from attendees

If our ERP already stores the NDC, are we safe? Not necessarily. Check where the field is mapped, because a BI report, a serialization interface or a verification step may still derive it from the GTIN.

Do we need to assess every camera and printer? No. Start with discovery. Cameras that already read 2D codes may need only a configuration update, while laser scanners will likely need replacing.

Do we have to support both formats at once? Yes, during the 2033–2036 transition. Agree with partners on when each product switches and how it is validated, whether per SKU, product family or line.

Will the FDA extend the deadline? It might, but we wouldn’t base a plan on it.

Next steps

For you to get prepared for the upcoming NDC-12 changes, here is a list of action you can take today to start getting ready:

To talk through your own lines and systems first, contact an OPTEL specialist.