Unique Ingredient Identifier

Unique Ingredient Identifier (UNII) is a system used to identify substances used in the production of pharmaceutical products. The UNII is a non-proprietary, free, unique, unambiguous, nonsemantic alphanumeric identifier linked to a substance's molecular structure or descriptive information by the United States Food and Drug Administration (FDA) and the United States Pharmacopeia (USP).

Overview

The UNII is assigned to substances that are used in the manufacture of pharmaceuticals, including active ingredients, excipients, and other ingredients. The UNII is not a chemical nomenclature, but rather a unique, non-semantic identifier. The UNII is generated based on a substance's molecular structure or descriptive information and is not related to any other identifier or system.

Purpose

The purpose of the UNII is to provide a unique identifier for each distinct substance used in the production of pharmaceuticals. This allows for clear communication and data exchange between organizations and systems. The UNII is used in regulatory submissions, labeling, and other applications where a unique identifier is needed.

Assignment

The UNII is assigned by the FDA's Substance Registration System (SRS). The SRS is a publicly accessible database that contains information on substances used in the production of pharmaceuticals. The SRS assigns a UNII to each substance in the database based on its molecular structure or descriptive information.

Use

The UNII is used in a variety of applications, including regulatory submissions, labeling, and data exchange. The UNII is used to identify substances in the FDA's Structured Product Labeling (SPL) system, which is used to create and manage product labeling. The UNII is also used in the FDA's Adverse Event Reporting System (AERS), which is used to track and analyze adverse events associated with the use of pharmaceutical products.

See also

• United States Food and Drug Administration
• United States Pharmacopeia
• Substance Registration System
• Structured Product Labeling
• Adverse Event Reporting System

References

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