National Drug Code

From manufacturer to dispensing pharmacy, in a way that enables rapid identification and removal of suspect or illegitimate products.

For drug manufacturers, the serialization requirement means that every saleable unit of a prescription drug must carry a unique product identifier, a standard combination of the National Drug Code, or NDC, a serial number, a lot number, and an expiration date encoded in a two-dimensional data matrix barcode.

Each unit must be serialized at the individual packaging level, and the transaction history must be maintained and transmissible throughout the supply chain.

The stabilization period in 2023 and the extended compliance timelines that followed have created some complexity around exactly which entities are fully required to be interoperable and by when.

The DSCSA was signed into law in twenty thirteen with a phased implementation timeline extending over a decade.

Its core objective is to build an interoperable electronic system for tracking and tracing prescription drug products through the pharmaceutical distribution supply chain, from manufacturer to dispensing pharmacy, in a way that enables rapid identification and removal of suspect or illegitimate products.

For drug manufacturers, the serialization requirement means that every saleable unit of a prescription drug must carry a unique product identifier, a standard combination of the National Drug Code, or NDC, a serial number, a lot number, and an expiration date encoded in a two-dimensional data matrix barcode.

Each unit must be serialized at the individual packaging level, and the transaction history must be maintained and transmissible throughout the supply chain.

So Liz, we were talking earlier, asking earlier, Matt earlier on that package, if there's an NDC code, you had something new about that?

Yeah, I had three interviews this week about the National Drug Code, NDC-12, which is a new thing that the FDA is putting into effect in 2033.

Last week was the Healthcare Distribution Alliance Traceability Seminar in D.C. And from there, the conversation was really about NDC-12.

It's a huge changeover that companies are going to have to make from 10-digit, which is the existing drug code, on packages to 12 and it sounds simple, but of course there's implications when we talk about what that looks like.

It's your printing and vision systems, your barcodes, your software inventory management, and this is far reaching.