National drug code

Tylenol bottle closeup (loose crop)

National Drug Code (NDC) is a unique identifier assigned to medications in the United States. The Food and Drug Administration (FDA) oversees the NDC system as part of its regulatory responsibilities. The NDC serves as a universal product identifier for human drugs.

Overview

The NDC is a numeric code that identifies the labeler (i.e., the company that manufactures or distributes the drug), the product (specific strength, dosage form, and formulation of a drug), and the commercial package size. The code is divided into three segments: the labeler code, the product code, and the package code. The FDA assigns the labeler code, while the labeler assigns the product and package codes following FDA guidelines.

Format

The standard NDC format is a 10-digit number, divided into three segments in a 4-4-2, 5-3-2, or 5-4-1 format. These segments represent the labeler code, product code, and package code, respectively. For example, in the 5-4-1 format:

• The first five digits identify the labeler,
• The next four digits identify the product,
• The last digit identifies the packaging.

Purpose and Use

The NDC serves multiple purposes:

• It facilitates the identification of drug products in the healthcare system, aiding in the management of drug inventories, billing, and claims processing.
• It is used in drug recall management, allowing for precise identification of affected products.
• Researchers and healthcare providers use NDCs to track the usage and distribution of drugs, which can inform public health decisions and drug safety measures.

Regulation

The FDA requires all over-the-counter and prescription drugs marketed in the U.S. to have an NDC. The code is also required for some biological products. Drugs imported into the United States must also comply with NDC requirements.

Challenges and Limitations

While the NDC is a critical tool for drug identification, it has limitations. The NDC does not convey information about the drug itself, such as its active ingredients or use. Additionally, changes in drug formulation, packaging, or labeler ownership can result in the assignment of a new NDC, which can complicate drug tracking and data analysis.

Future Directions

Efforts are ongoing to enhance the utility and accuracy of the NDC system. These include initiatives to standardize data entry and retrieval processes and to integrate the NDC with global drug identification systems to improve drug safety and tracking on an international scale.