National Drug Code System

The National Drug Code (NDC) System is a system that is designed to provide drugs in the United States with a specific 11-digit number that describes the product. Originally created under Medicare to help identify drugs for reimbursement, the usefulness of the system has now become more widespread.

Description

The NDC System provides a directory of selected over-the-counter agents, insulin formulations, and prescription drug products, and herbal drugs distributed in the United States. Originally, the system was established by Medicare as part of an outpatient drug reimbursement program and a method to identify drugs during commercial distribution. It now enjoys a more widespread application; however products may not be included in the directory if the firm has not communicated the most recent status to the Food and Drug Administration (FDA) (e.g., drug has been discontinued). Data in the NDC are updated quarterly (March, June, September, and December). The FDA requires firms to submit updated registered drug lists in June or December of each year (or sooner as new information about a drug becomes available to the firm).

Drugs listed under the NDC are identified by an 11-digit number divided into three segments. The first segment, assigned by the FDA, identifies the vendor (or labeler) involved with the manufacturing, packaging, or distribution of the drug. Product codes, listed in the second segment, comprise the generic entity, strength, and dosage form. The third segment, or package code, indicates the package size. The manufacturer assigns the second and third segments of the code for a given product. Notably, government agencies such as Medicaid or Medicare, display the code in an eleven digit format with leading zeros.

The NDC system may assist in ensuring the safe dispensing of prescription medications. For example, outpatient pharmacists may use the NDC system to avoid confusion with look-alike/sound-alike drugs. See ISMP Quarterly Action Agenda: October-December, 2001 for an example. Also in an attempt to reduce or prevent medication errors, the FDA issued a final rule in February 2004 requiring bar codes for prescription drugs and blood products by February 2007. Minimum standards for the bar code include the NDC number.

The Directory is organized as follows:

• Product Trade Name or Catalog Name
• National Drug Code (unique 11 digit, 3 segment number). The segments represent the labeler code, the product code and the package code.
• Dosage Form
• Routes of Administration
• Active Ingredients
• Strength
• Unit
• Package Size and Type
• Major Drug Class
• FDA approved application number (note that “other” in this field means it may not have been approved).

At National Drug Code Directory, a search may be conducted by proprietary name, active ingredients, application number, NDC number, or firm name. The Orange Book and Micromedix's Redbook also use NDC numbers in their information tyiuo assist in cross-referencing and identification.

For information specific to vaccines, see Vaccine Identification Standards Initiative.

For NDC and HCPCS crosswalk, see dmepdac.com.

Inclusion of a drug in the directory does not mean that the FDA has approved the drug or that Medicare, Medicaid or other payers will reimburse for it. It should also be noted the numbers may be reused. Some have attempted to move to a clinically-based code system to avoid some of the pitfalls of frequent changes and number reuse. [1]