NDC Numbers

What are the NDC Number and the National Drug Code Directory?

The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution. (See Section 510 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360)). Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which is a universal product identifier for human drugs. FDA inputs the full NDC number and the information submitted as part of the listing process into a database known as the Drug Registration and Listing System (DRLS). Several times a year, FDA extracts some of the information from the DRLS data base (currently, properly listed marketed prescription drug products and insulin) and publishes that information in the NDC Directory.

The information submitted as part of the listing process, the NDC number, DRLS, and the NDC Directory are used in the implementation and enforcement of the Act.

According to Wikipedia, National Drug Code (NDC) is a unique 10-digit, 3-segment number assigned to each medication listed under Section 510 of the U.S. Federal Food, Drug, and Cosmetic Act. The number identifies the labeler or vendor, product, and trade package size.

• The first segment, the labeler code, is assigned by the Food and Drug Administration (FDA). A labeler is any firm that manufactures, repacks or distributes a drug product.
• The second segment, the product code, identifies a specific strength, dosage form, and formulation for a particular firm.
• The third segment, the package code identifies package sizes.

Both the product and package codes are assigned by the firm.

The NDC will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1.

Each item is barcoded with a Universal Product Code that begins with a 3 (UPC-A) or 03 (EAN-13). The remainder of the numbers are the NDC number, plus the check digit.

An asterisk may appear in either a product code or a package code. It simply acts as a place holder and indicates the configuration of the NDC. Since the NDC is limited to 10 digits, a firm with a 5 digit labeler code must choose between a 3 digit product code and 2 digit package code, or a 4 digit product code and 1 digit package code.

Thus, you have either a 5-4-1 or a 5-3-2 configuration for the three segments of the NDC. Because of a conflict with the HIPAA standard of an 11 digit NDC, many programs will pad the product code or package code segments of the NDC with a leading zero instead of the asterisk. For consistency, other Government agencies may display the NDC in an eleven digit format. For example, the Centers for Medicare and Medicaid Services (CMS) displays the labeler code as 5 digits with leading zeros; the product code as 4 digits with leading zeros; the package size as 2 characters with leading zeros.

Since a zero can be a valid digit in the NDC, this can lead to confusion when trying to reconstitute the NDC back to its FDA standard. Example: 12345-0678-09 (11 digits) could be 12345-678-09 or 12345-0678-9 depending on the firm's configuration. By storing the segments as character data and using the * as place holders we eliminate the confusion. In the example, FDA stores the segments as 12345-*678-09 for a 5-3-2 configuration or 12345-0678-*9 for a 5-4-1 configuration.

What products are included in the NDC Directory?

The current edition of the NDC Directory is limited to prescription drugs and insulin products that have been manufactured, prepared, propagated, compounded, or processed by registered establishments for commercial distribution. The products have been listed in accordance with the Drug Listing Act and regulatory provisions concerning the submission of drug product information to FDA.

Each listed drug product listed is assigned a unique 10-digit, 3-segment number. This number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. A labeler is any firm that manufactures (including repackers or relabelers), or distributes (under its own name) the drug. The second segment, the product code, identifies a specific strength, dosage form, and formulation for a particular firm. The third segment, the package code, identifies package sizes and types. Both the product and package codes are assigned by the firm. The NDC will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1.

An asterisk may appear in either a product code or a package code. It simply acts as a place holder and indicates the configuration of the NDC. Since the NDC is limited to 10 digits, a firm with a 5 digit labeler code must choose between a 3 digit product code and 2 digit package code, or a 4 digit product code and 1 digit package code.

Thus, you have either a 5-4-1 or a 5-3-2 configuration for the three segments of the NDC. Because of a conflict with the HIPAA standard of an 11 digit NDC Number, many programs will pad the product code or package code segments of the NDC with a leading zero instead of the asterisk.

Since a zero can be a valid digit in the NDC, this can lead to confusion when trying to reconstitute the NDC back to its FDA standard. Example: 12345-0678-09 (11 digits) could be 12345-678-09 or 12345-0678-9 depending on the firm's configuration. By storing the segments as character data and using the * as place holders we eliminate the confusion. In the example, FDA stores the segments as 12345-*678-09 for a 5-3-2 configuration or 12345-0678-*9 for a 5-4-1 configuration.

NDC Numbers on Claims

Some insurance companies are requiring that the National Drug Code (NDC) numbers be added to claims to ensure reimbursement or, in some cases, higher reimbursement. Why are they doing this?

In August 2000, the Department of Health and Human Services (HHS) published a final rule on "Standards for Electronic Transactions" that established NDC numbers as the standard medical data code set for reporting drugs and biologics in all standard transactions under the Health Insurance Portability and Accountability Act (HIPAA). To comply with those standards, some insurers may have started requiring NDC numbers on their claims. However, in February 2003, HHS repealed the NDC as the standard medical data code set for drugs and biologics in all but retail pharmacy transactions. At this time, no standard code set for drugs and biologics has been adopted for non-retail-pharmacy transactions. Until a new standard code set for drugs and biologics is adopted for non-retail-pharmacy transactions, insurance companies may continue to require NDC numbers or a combination of HCPCS codes (level two) and CPT vaccine codes for reporting drugs or biologics.