Who Assigns Labeler Codes?

Prescription Drug Labeler Code

Confusion often arises when evaluating what the labeler code is and who assigns it. When drugs are labeled, the first section of the NDC (National Drug Code) number is classified as the labeler code. Labeler codes are requested by the manufacturer and are required for any manufacturer or distributor who lists NDCs with the FDA. A Labeler Code Request SPL file must be sent to the FDA, where it will then be reviewed, and a labeler code will be sent within 10 business days. This code is assigned by the FDA and identifies the firm who manufactures or markets the drug. This code is required before the drug listing can be submitted. In the event that the code has not been used in a listing for 24 months, the code will become inactivated following notification from the FDA.

Medical Device Labeler Code

For the labeling of medical devices, per FDA rules, Unique Device Identifiers (UDI) are now to be used instead of NDCs or NHRICs (National Health Related Item Code). The FDA accredited three organizations as UDI issuing agencies: GS1, Health Industry Business Communications Council (HIBCC), and International Council for Commonality in Blood Banking Automation (ICCBBA). Each issuing agency has a unique UDI format that was reviewed and approved by FDA as part of its process for accrediting issuing agencies.

Medical devices are to be assigned a UDI, which identifies devices from the manufacturing process through distribution and patient use. To acquire this code, the device manufacturer must contact one of the UDI issuing agencies accredited with the FDA to generate an identifier, which is then submitted, along with the device information, to the Global Unique Device Identification Database (GUDID) for approval. The UDI consists of a device identifier (DI) and a production identifier (PI).

The PI portion of the UDI includes information such as lot numbers, serial numbers, and expiration dates. The main purpose for this code is to improve patient safety, increase post market surveillance, and facilitate medical device innovations. A major benefit to the UDI is identifying medical devices in the event of recalls. These unambiguously facilitate the traceability through the supply and market chains. The UDI is found on the device label, packages, or on the device itself. For most nonsterile devices, the UDI will be found on the device itself. Sterile devices must consult the FDA for alternatives.

GS1

This section of the article focuses on the DI portion of the UDI created using the standard developed by GS1, an information standards organization. The DI identifies the labeler and the specific version or model of a device. GS1 developed a suite of standards that provide information regarding the identification of the product, services, logical matters (such as service relations), and even physical locations. Companies can utilize the GS1 system to create an identifier and obtain a barcode label for their medical device.

Companies first apply for a GS1 company prefix code. This prefix code will recognize the company’s ownership of the identifier and the product to which the identifier is attached. For pharmaceutical manufacturers or repackagers also selling devices, companies may request that their assigned NDC Labeler code be incorporated into their GS1 Company Prefix, if available.  To acquire the prefix, the company must purchase the membership from GS1 and declare the number of products that will use the prefix. The length of the prefix is dependent upon the number of products the company plans to identify using the prefix.

Each product from a given company will possess a global trade identification number (GTIN) beginning with the company’s prefix code. The GTIN is assigned by the manufacturer, who must follow the rules outlined by GS1 to ensure it is unique and correctly formatted. The GTIN serves to identify trade names of a company. This includes any products or services that exist to be priced, ordered, or invoiced at any point within the supply chain as they move toward the ultimate end user. This number is used to identify various packaging levels for a product, such as the quantity of items in the box or the quantity of boxes within the carton.

For the purposes of the UDI, when the GS1 standard is used to create the DI portion the identifier, the GTIN-14 format is utilized.  Compendia then reformat the GTIN-14 into an 11-digit product identifier that can be used for billing claims for medical devices or digital therapeutics.

In the example below, the entire identifier is the UDI.  Within the identifier, the numbers in parentheses are known as Application Identifiers (AI), which specify what the values in the four sections shown in the example represent. The DI portion of the UDI is the 14-digit number, or the GTIN-14, that follows the AI labeled (01).  The rest of the UDI is the PI portion.  The first digit of the GTIN-14 identifies the packaging level and the last digit is the check digit.  The 12 digits in the middle consist of the variable length GS1 Company Prefix and the variable length item identifier.

HIBCC

A manufacturer may choose to use Health Industry Business Communications Council (HIBCC), another of the FDA accredited organizations, as a UDI issuing agency.  Companies must first obtain a company prefix from HIBCC, which is called a Labeler Identification Code (LIC).  HIBCC assigns a four-character alphanumeric LIC to the company for use in the UDI.  The assigned LIC identifies the registered company, not an individual product or device.  The LIC can be used across multiple product lines.  Once assigned an LIC, the company can begin to create identifiers at multiple packaging levels, depending upon the required granularity of identification necessary.

Since the manufacturer’s LIC and the product’s DI contain alpha characters, the DI cannot be reformatted into an 11-digit numeric identifier that can be listed in pricing compendia or used for data transactions and claims. Currently, only 11-digit product identifiers can be used universally for transactions and claims.  Pending new government rules for the National Drug Code and new mandated standards for claims submission, the industry will be evaluating the use of each identifier in their native form, without reformatting.  However, implementation of new processes allowing for this is still more than two years in the future.

Navigating these codes and labeling processes can be confusing and difficult. Pharmacy Healthcare Solutions offers the knowledge and experience to ensure accurate knowledge is conveyed while following respective guidelines. Contact PHSL for assistance with questions related to labeler code assignment or help with listing these products in the leading drug pricing compendia.

Posted September 2023 and Updated October 2023 with HIBCC details