Whitepaper: Revising the National Drug Code Format and Drug Label Barcode Requirements for the U.S. Market
Overview: Today, the National Drug Code (NDC) is a 10-digit, three-segment identifier with multiple valid segment patterns (4-4-2, 5-3-2, 5-4-1). In parallel, there is also a widely used 11-digit NDC format (NDC11) defined under HIPAA for electronic transactions, which is a legitimate standard representation of the NDC used in claims, reimbursement, and many payer-facing workflows. The availability of NDC number ranges has become increasingly constrained due to continuous product releases and new market entrants. Moving to a 12-digit format expands capacity and consolidates the current mix of formats into a single standard structure. Moving to a 12-digit format expands capacity and consolidates the current mix of formats into a single standard structure.
The change may disrupt long-standing technical practices, especially the way U.S. drug products have used a direct mapping from NDC10 into GS1 GTIN-14. Because GTIN-14 cannot natively accommodate a full 12-digit NDC plus prefix and check digit, GS1 and industry stakeholders are faced with having to adopt new interoperability models.
The U.S. Food and Drug Administration (FDA) has proposed a significant change to how drugs are identified and encoded in the United States. In the proposed rule “Revising the National Drug Code Format and Drug Label Barcode Requirements” (Docket FDA-2021-N-1351), the FDA introduces a standardized 12-digit National Drug Code (NDC12) in a 6-4-2 structure and updates barcode requirements to align with this new format.
FDA first proposed the NDC12 format in its July 25, 2022 proposed rule, “Revising the National Drug Code Format and Drug Label Barcode Requirements” (Docket FDA-2021-N-1351). Since then, FDA has reiterated the concept of a 12-digit NDC so far without a final rule, While the actual “go-live” timing for NDC12 remains unknown, preparations are due now to be ahead of major changes throughout parts of any organization.
This white paper blends the original high-level summary with a more detailed narrative, offering both clear structure and practical depth. It explains the new NDC format, explores stakeholder impacts, describes the implications for GTIN, and outlines concrete next steps and emerging solution options.
Background
The National Drug Code is a fundamental identifier in the U.S. healthcare system. It appears on drug labels, in FDA listing systems, in pharmacy and hospital software, in claims and reimbursement workflows, and in many supply chain and safety processes.
Historically, the NDC has been:
- A 10-digit numeric code,
- Divided into three segments:
- Labeler (manufacturer, repackager, or distributor),
- Product (specific strength, dosage form, and formulation),
- Package (size and type).
Because the code space has been used flexibly, three main segment formats are in use:
- 4-4-2
- 5-3-2
- 5-4-1
In every case the order is Labeler–Product–Package, but systems are faced with having to be capable of recognizing and interpreting multiple layouts. This is manageable, but it forces additional logic and special handling in databases, Electronic Health Record system, Warehouse Management System, billing systems, and other applications.
The primary driver for change is exhaustion of labeler codes. As more products and more labelers enter the market, the available labeler code space in the current 10-digit framework is projected to be exhausted within roughly a decade.
A secondary driver is fragmentation. NDC10 and HIPAA NDC11 formats, each with multiple segment patterns, introduce complexity and risk. The proposed NDC12 format responds to both challenges by expanding capacity and enforcing a single, consistent structure.
Key Changes
A. NDC Format Revision
Under the proposed rule, the NDC becomes a 12-digit code with a standard 6-4-2 structure:
- 6 digits – Labeler code (manufacturer/distributor),
- 4 digits – Product code (strength, dosage, formulation),
- 2 digits – Package code (size/type).
This change:
- Expands the pool of available labeler codes,
- Eliminates the coexistence of 4-4-2, 5-3-2, and 5-4-1 formats,
- Simplifies system validation, since any 12-digit numeric value in this context can be parsed in a uniform way.
Existing NDCs will be converted to NDC12 primarily via leading zeros in the appropriate segments, so that previously assigned products can be carried forward in the new structure.
B. Drug Label Barcode Requirements
Drug labels are already subject to barcode requirements under 21 CFR 201.25. The proposed rule updates those requirements so that:
- Barcodes should encode the new 12-digit NDC once the rule is effective and transition periods are complete.
- This applies across the medication use process, supporting compatibility with:
- Hospital and clinical scanning systems,
- Retail and specialty pharmacy workflows,
- Wholesaler and manufacturer supply chain systems.
Machine-readable barcodes will typically use linear symbologies (such as UPC or GS1-128) or 2D codes (such as GS1 DataMatrix). As the industry shifts toward 2D barcodes for serialization and DSCSA compliance, the way NDC12 and GTIN are combined in those symbols becomes a critical design decision.
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