The US National Drug Code and Generic Product Identifier (GPI)

The US National Drug Code (NDC) is a unique product identifier for drugs intended for human consumption. Under the Drug Listing Act of 1972, all registered drug establishments must provide FDA with a current list of their drugs. NDCs are used to identify and report drug products. Alternatively, alternative drug classification systems, such as Generic Product Identifier (GPI), are commonly used for drug data analysis. This article outlines the main aspects of each.

GS1

When manufacturers want to use a standardized label for a product, they will use the US National Drug Code (NDC). NDCs will be assigned to the manufacturer of the product and will be embedded in GTINs. The GTINs will be composed of the labeler code and the GS1 Company Prefix. The labeler code will identify the drug, which will be the last digit of the GS1 Company Prefix.

To apply for a GS1 license, pharmaceutical companies must have an assigned NDC or NHRIC from the FDA. Only pharmaceutical companies can apply for a GS1 license. Afterward, companies must renew their license. The fee is $2100 for the first year and another $1200 for each subsequent year. The license is valid for five years and must be renewed every five years. The GS1 US will issue a GTIN for all products with FDA Labeler Code.

HIBCC

HIBCC is an organization that was created to provide health care standards to manufacturers and distributors. Its standards are the first to incorporate the National Health Related Industry Code (HIBCC) and the US National Drug Code. The FDA assigns these two codes to all pharmaceuticals and other products. Since their development, the health care industry has used them in many different areas. In 1988, HIBCC expanded to foreign countries and promulgated HIBCC-based standards.

The NDC is a nine-digit code used to identify a specific drug by the US National Food and Drug Administration (FDA). The NDC for a particular drug may be in one of three different configurations. In each configuration, a number is assigned to each segment, representing the number of digits contained in the NDC. In addition, NDC codes can be re-assigned to the same or different products if a new supply is obtained.

INSEE

The National Drug Code, or NDC, is a unique 10 or 11-digit number that uniquely identifies human drugs in the United States. The NDC has three main segments: the product labeler, the product itself, and the package size. In the US, NDCs are used in over 4,000 pharmaceutical products. This makes them an invaluable tool for quality control, fraud detection, and more.

The proposed change includes changes to the way that NDCs are assigned. The five-digit format is expected to provide 90,000 possible combinations, but the government anticipates that this will run out by 2033. During the last two years, the FDA held a public hearing on the issue, during which it listened to the concerns of healthcare industry stakeholders. In January 2019, the FDA released a proposed rule open to public comment.

PEPID

The PEPID Info button is a contextual tool that enables clinicians and patients to access the latest drug information and related patient resources. PEPID offers a single platform with comprehensive content, clinical illustrations, and links to relevant labs, physiology, and technology information. It also allows physicians to print patient-specific information. The tool is also HL7-compliant and is standardized with system vocabularies.

The PEPID RN is a comprehensive reference tool for nurses, with over 20 authors. It includes disease-specific clinical content, a comprehensive drug database, and health and wellness teaching guides. The tool was developed by a multidisciplinary team of physicians and nurses. PEPID RN includes a drug database, a medical calculator, illustrations, abbreviations, and nursing procedures. It is designed with the clinician in mind and offers a user-friendly interface.

To know more Visit: 

US NDC Archives

https://www.gnhindia.com/products/us-ndc/