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Understanding the packaging indicator in a GTIN-14 is essential for distinguishing pharmaceutical products across different packaging levels. From single-dose units to master cases, this leading digit encodes a product’s position in the packaging hierarchy—without changing its identity. Correct usage ensures seamless serialization, barcode accuracy, and DSCSA compliance. Whether labeling a vial or pallet, assigning the right packaging indicator is a small step with big implications for traceability and supply chain integrity.

Explains how to accurately convert National Drug Codes (NDC-10 and NDC-11) to GTIN-14 identifiers for use in GS1-compliant barcodes. It emphasizes the importance of using the officially assigned 11-digit NDC rather than inferring it from the 10-digit format. The article outlines the GTIN-14 structure, provides a detailed check digit calculation method, and includes Python code to automate the process. This guidance is essential for pharmaceutical serialization, traceability, and DSCSA compliance.

As the U.S. drug supply chain grows more automated, the FDA is proposing a shift from the current 10- and 11-digit National Drug Code (NDC) formats to a standardized 12-digit structure. This change is driven by the looming exhaustion of 5-digit labeler codes and aims to enhance clarity, automation, and long-term sustainability. NDC 12 adopts a fixed 6-4-2 segment format, enabling better compatibility with GS1 standards, improved barcode readability, and seamless integration with traceability systems. The transition, expected to begin in 2025, will impact barcoding, GTINs, and data processing systems-requiring healthcare organizations to start preparing now.

As pharmaceutical supply chains shift toward unit-level traceability under regulations like DSCSA and the FMD, the structure of RFID-encoded drug data is becoming crucial. This post explains how GS1’s EPC encoding formats—SGTIN-96, SGTIN-96+, and SGTIN-198—impact drug serialization and compliance. While SGTIN-96 requires external databases, SGTIN-96+ adds expiration and lot number data to user memory for offline verification. However, EPC 2.x’s SGTIN-198 format fully embeds all critical data within the tag itself, offering the most standardized, compliant, and future-ready solution. For long-term interoperability and regulatory alignment, EPC 2.x is the recommended path forward.

To meet the stringent tracking requirements of the Drug Supply Chain Security Act (DSCSA), pharmaceutical companies must adopt secure and interoperable product identification systems. This blog post outlines how open RFID standards—specifically GS1 EPC and RAIN RFID—enable scalable, compliant drug serialization across the entire supply chain. GS1 embeds complete product data directly on RFID tags, eliminating database dependencies and simplifying compliance. RAIN RFID offers a hybrid model using third-party lookups while maintaining global compatibility. Compared to proprietary systems, these open standards reduce vendor lock-in, enhance transparency, and ensure long-term regulatory alignment—especially critical as the DSCSA 2024 electronic tracing deadline nears.