Stay Ahead of NDC-12 Compliance: Grab Your Free Toolkit

Will the FDA extend the deadline like it did for DSCSA?

Don't plan on it. As one attendee rightly pointed out, FDA has said it cannot extend: the deadline is driven by running out of 10-digit codes, not by industry readiness. That's exactly why starting now matters.

Since the NDC is no longer built into the GTIN, how do we get new GTINs issued? Can we keep our existing GTINs?

You keep your existing GTINs. FDA isn't issuing new ones. On March 7, 2033, FDA automatically converts existing NDCs to the 12-digit format and treats this as an administrative change, not a new NDC. The NDC is then carried in the barcode using GS1 AI (715) alongside the GTIN. For new products, you'll continue to assign GTINs from your GS1 Company Prefix, but stop deriving them from the NDC.

Is GS1 ready?

Yes. GS1 has already created AI (715), supported in GS1-128, GS1 DataBar and 2D DataMatrix. FDA's guidance references it directly, and GS1 US continues to publish implementation guidance.

Do we need to assess every camera and printer on every line?

Not necessarily, but you do need to go line by line. Cameras that already read 2D codes may only need a software or configuration update. Linear laser scanners that infer the NDC from the GTIN will likely need replacing. On the print side, the key question is whether the packaging and artwork have room for the extra NDC line and, in some cases, a larger DataMatrix.

Do we still need a separate NDC barcode if the serialization code includes the NDC on an extra line?

For most Rx products, no. The final rule allows linear or 2D barcodes, and a single 2D DataMatrix can satisfy both the FDA barcode and DSCSA requirements from March 7, 2033. The NDC must be encoded in the DataMatrix via AI (715); the human-readable line alone doesn't meet the requirement. OTC is a separate decision: retail scanning is still largely UPC-based, and GS1 Sunrise 2027 (2D barcodes at retail checkout) will shape how you carry the NDC.

How will hand scanners and shipping systems be impacted? Are Zebra and Cognex involved? Will 3PLs have the same timeline?

2D-capable imagers generally need only a software or parsing update; linear-only laser scanners will likely need replacing. Shipping and WMS systems need the same fix as ERPs. Check with device vendors directly on their roadmaps; the GS1 US Healthcare workgroup is the main industry forum. There's no separate 3PL timeline: anyone using NDCs must handle the 12-digit format by the effective date.

If we already store the NDC as its own field in our ERP, are we safe from the GTIN "shortcut"?

Not necessarily. Having the field is step one. The real question is where that field goes. Check that it's mapped to every downstream interface, including serialization, BI reports, verification and partner data exchange, and that none of them still derive the NDC from the GTIN.

Will we need to support 10- and 12-digit formats at the same time? How will cutover work for legacy products, EPCIS and partners migrating on different schedules?

Yes. Systems must handle both formats through the transition period (March 7, 2033 to March 6, 2036). Brand owners and CMOs should put the cutover in their quality agreements: when each product switches, who triggers it, how it's tested and who validates it. Cutover may happen by SKU, product family or packaging line.

Will future GTINs include the NDC again?

No. Plan on the GTIN and NDC being separate from 2033 onward, linked through master data and encoded separately in the barcode.

What's the impact on existing systems, and what testing is required?

On the line, it depends on your current software version, cameras, printers and artwork. Recent installations may need only a small change control; older ones may need more. At the enterprise level, first find out whether the shortcut exists in your systems, then confirm you can manage both NDC formats and coordinate cutover with packaging sites and downstream partners.

Is OPTEL ready for AI (715) today?

Yes, current line versions support AI (715). Older installations may need an upgrade, which we can confirm during an assessment.

For OPTEL report connectors that extract the NDC from the GTIN, is there an easy fix?

Typically yes: a configuration and mapping change to read the NDC from a dedicated master data field (or AI 715) rather than from the GTIN. Your Customer Success Manager can review your reports with you.