FDA Product Codes and Product Code Builder, A Guide to Coding System used by FDA

· The easiest way to determine the product code is to become familiar with the product itself, including the label, the processing information, intended use of product, the container type, who will use or consume the product, etc.

What is an FDA product code?

An FDA product code describes a specific product and contains a combination of five to seven numbers and letters. The product code submitted with each FDA line item should match the actual product name and/or invoice description of the product.

If the product has more than one name (e.g., a fish known under several regional names), the product code may have several different synonymous definitions associated with it. The easiest way to determine the product code is to become familiar with the product itself, including the label, the processing information, intended use of product, the container type, who will use or consume the product, etc.

What is the structure of an FDA product code?

The string of letters and numbers represents five components: Industry Code, Class, Subclass, Process Indicator Code (PIC), and the Product (Group).

Industry	Class	Subclass	Process Identification Code (PIC)	Product
Number	Letter	Letter or Hyphen (-)	Letter or Hyphen (-)	Letter or Number

Industry Code: This element is two numbers from "02" to "98.” 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 Code: This element is always one letter (a-z) and is directly related to an industry. It designates the food group, source, product, use, pharmacological action, category, or animal species of the product. Class is more specific than an industry code; for example, the fishery/seafood products industry may contain classes such as crustaceans or hot-smoked fish. All products will have a Class Code. Class codes for radiation-emitting products, medical devices and in-vitro diagnostics are linked to the Product (Group) letters, see below.

Subclass Code: This element is one letter (a-z) and represents the container type, method of application, use, market class or material the product is being packaged in. The subclass should specify the primary material which contacts and/or holds the product. Medical devices do not have subclass codes and are represented by a hyphen.

Process Indicator Code (PIC): This element is one letter (a-z) and describes the process, storage or dosage form depending on the type of product. When in doubt, you may wish to contact the manufacturer for processing information. Medical devices, cosmetics, and some animal use products do not have a PIC and are represented by a hyphen.

Product (Group): This element is two characters in length and may contain either letters or numbers. This element relates directly to a particular industry/class combination. This element identifies the specific product. For medical devices, the product (group) element is two letters and when used in conjunction with the class element, identifies a specific medical device.

Examples of Product Codes

Example 1: Food Product Code
Product: Canned Tomato Soup (Concentrated)
Product Code: 38BEE27

Example 1 - Food Product Code

Structure	Industry	Class	Subclass	Process Identification Code (PIC)	Product
Format	Number	Letter	Letter or Hyphen (-)	Letter or Hyphen (-)	Letter or Number
Sample	38	B	E	E	27
Meaning	Soup	Soup, Conc	Metal	Commercially Sterile	Tomato Soup, Concentrated

Example 2: Drug Product Code
Product: Ibuprofen
Product Code: 62GBA41

Example 2 - Drug Product Code

Structure	Industry	Class	Subclass	Process Identification Code (PIC)	Product
Format	Number	Letter	Letter or Hyphen (-)	Letter or Hyphen (-)	Letter or Number
Sample	62	G	B	A	41
Meaning	Human and Animal Drugs	Anti-Inflammatory	Human - Non/Rx Combo Ingredient	Prompt Release Tablets	Ibuprofen

Example 3: Medical Device Product Code
Product: First Aid Kit including drugs
Product Code: 79L--RR

Example 3 - Medical Device Product Code

Structure	Industry	Class	Subclass	Process Identification Code (PIC)	Product
Format	Number	Letter	Letter or Hyphen (-)	Letter or Hyphen (-)	Letter or Number
Sample	79	L	Hyphen (-)	Hyphen (-)	RR
Meaning	General & Plastic Surgery	Kit			Kit, First Aid

What resources are available to help me create a product code?

· Product Code Builder Tutorial: The Product Code Builder Tutorial gives you the information you need to successfully code products. It contains seven lessons. You can go through them in order or jump to a lesson that meets your immediate needs. Four of the lessons cover specific commodity groups:

o Lesson 4: Coding Food, Food-Related, Cosmetic and Vitamin Products

o Lesson 5: Coding Drugs, Drug Products and Biologics

o Lesson 6: Coding Animal Use Products

o Lesson 7: Coding Medical Device, In-Vitro Diagnostic and Non-Medical Radiation Emitting Products

· Product Code Builder: The Product Code Builder Application is a tool you can use to build a product code. By building upon the code portions you select, the application will provide you with choices for each of the five components of the product code (Industry, Class, Subclass, PIC, and Product). The Product Code Builder has helpful tips to assist in building a product code.

· Product Code Builder Application Programming Interface (API): The Product Code Builder API is a web service that provides the capability for software programmers to build a user interface that retrieves information from the Product Code Builder database. This does not replace the current online Product Code Builder but compliments it by providing trade a method to program existing software to query and verify FDA Product Codes.