The FDA Product Code is a seven characters long and is broken into the following five fields.

Industry Code is the first of five elements that comprise an FDA product code. This element is two characters in length and currently consists of numeric data. Industry codes range from "02" to "97." An Industry code determines the broadest area into which a product falls. Some examples are Dental for all dental-related medical devices and Fishery/Seafood for fish and seafood products.

Class is the second of five elements that comprise a FDA product code. This element is one character in length, and is always an alpha character. This element is directly related to an Industry. This code designates the food group, source, product, use, pharmacological action, category or animal species of the product. A Class code is more specific than an Industry; for example, the Fishery/Seafood products Industry may contain Classes such as Smoked, Breaded and such. However, not all Industry codes have specific class elements. Industries 73 – 93 are used to describe medical devices. The product codes for medical device and in-vitro diagnostic products are found in a Department of Health and Human Services publication entitled "Classification Names for Medical Devices and In-Vitro Diagnostic Products." The codes are the responsibility of the Food and Drug Administration's Center for Devices and Radiological Health (CDRH). These codes are part of the OASIS database that is used by the Product Code Builder application. Each product name is identified by a product code that consists of five digits (2 numeric, 3 alpha). The first two digits indicate the medical specialty under which the device or diagnostic product was originally classified. See Lesson 7 - Coding Medical Device, In-Vitro Diagnostic, and Non-Medical Radiation Emitting Products for more information.

Subclass is the third of five elements that make up a FDA Product code. This element is one character in length, and is always an alpha character or a hyphen "-". It represents the container type, method of application, use, market class, or type of product. The Subclass relates directly to a particular Industry grouping and utilizes a unique set of definitions specific to those products. At this time, it is not used in medical device product codes and some animal use products. When not used, subclass is represented by a hyphen "-".

Process Indicator Code (PIC) is the fourth of the five elements in the product code. This element is one character in length, and is always an alpha character or a "-". It specifies either the process, storage or dosage form depending on the type of product. In the case of kitchenware, the PIC describes the material that the product is made of. At this time, it is not used in coding some products such as cosmetics, medical device product codes and some animal use products. The PIC code is represented by a hyphen "-" for those Industries to which it does not apply.

Product is the fifth and last element that comprises the product code. This element is two characters in length, and may contain either numeric or alpha data. The Product relates directly to a particular Industry/Class combination. For example, for the Fishery/Seafood Industry and the Smoked Class within that Industry, specific types of seafood (sole, flounder, salmon, etc.) would have specific Product element values.

For medical devices, the Product element is two alpha characters. While it has no particular meaning, used in conjunction with the Class element it identifies a specific product. See Lesson 7 - Coding Medical Device, In-Vitro Diagnostic, and Non-Medical Radiation Emitting Products for more information.

The Industry Code must first be determined before the Class, Subclass, or PIC can be determined; and the Class must be determined before the specific Product code can be determined. You can streamline this process when you use the Product Code Builder Application. Use Option 3 Search Product Name to search for the product name or a keyword associated with the product name. The search results will be categorized by Industry. Select a product in one of the industries and the application will select the corresponding Class code. Then determine the Subclass and Process Indicator Code to complete the Product Code.

The case study walks through the coding process step-by-step. Read through the case study and answer the questions.

Let's say you need the product code for cans of Condensed Cream of Mushroom Soup. The first step is to determine the Industry Code. Searching the list of industries, you will come across an industry labeled Soups. The Industry Code for Soups is 38.

The Product Code Builder Application is set up to select the Product next. Then you select the Subclass and PIC codes. In our example, there are 26 products listed including Number 19 – Mushroom, Creamed, Concentrated. That is the one you would select. The Product so far looks like this:

Product: Condensed Cream of Mushroom Soup

FDA Product Code: