The key difference between National Drug Code (NDC) and Generic Product Identifier (GPI) lies in their scope and purpose: NDC uniquely identifies a specific drug product, including the manufacturer, package size, and formulation, while GPI categorizes pharmaceutically equivalent drug products into a standardized hierarchical system.
NDC (National Drug Code)
The NDC is a unique, three-segment number assigned to each medication package registered with the FDA. These three segments identify the labeler (manufacturer, repackager, or distributor), the product (specific strength, dosage form, and formulation), and the package size.
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Structure: A typical NDC is formatted as XXXXX-YYYY-ZZ, where:
- XXXXX represents the labeler code.
- YYYY represents the product code.
- ZZ represents the package code.
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Purpose: NDC codes are primarily used for inventory management, billing, and tracking drug utilization at the individual product level.
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Specificity: Highly specific; differentiates between different manufacturers and package sizes of the same medication.
GPI (Generic Product Identifier)
The GPI is a hierarchical classification system developed by Medi-Span (Wolters Kluwer) that groups pharmaceutically equivalent drug products. It provides a standardized way to categorize drugs based on their therapeutic class and mechanism of action, regardless of the manufacturer or package size.
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Structure: GPI codes are typically 14 characters long and are structured to represent different levels of classification, from broad therapeutic categories down to specific drug ingredients and strengths.
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Purpose: GPI codes are primarily used for drug pricing analysis, formulary management, and identifying therapeutic alternatives.
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Specificity: Less specific than NDC; groups similar drugs together, regardless of manufacturer or package size.
Key Differences Summarized
| Feature | NDC | GPI |
|---|---|---|
| Purpose | Unique product identification & tracking | Categorizing pharmaceutically equivalent drugs |
| Specificity | High (product, manufacturer, size) | Lower (therapeutic class, mechanism of action) |
| Structure | Three-segment number (XXXXX-YYYY-ZZ) | 14-character hierarchical code |
| Use Cases | Inventory, billing, drug utilization | Drug pricing, formulary management, therapeutic alternative identification |
In essence, while an NDC tells you exactly what a drug product is (down to the manufacturer and package size), a GPI tells you what kind of drug it is (in terms of its therapeutic category and mechanism of action). Understanding both is crucial for a comprehensive understanding of the pharmaceutical landscape.
