Drug Listing Procedures for Kits (Form FDA 2657)

When a product is made up of two or more components, as in a kit, a Form FDA 2657 must be used for the kit and each component. The first Form FDA 2657 will include information for the kit and the subsequent Form FDA 2657's will include information for each component of that kit. Indicate all numeric "zeros" as . Number each page on the lower right corner.

The first Form FDA 2657 will contain the following information regarding the entire kit:

Section 01

Name and Site Address of Firm

Col. 18 - S - Leave blank

Col. 19 - U - Leave blank

Col. 20-83 - Kit Trade Name

Col. 84-89 - National Drug Code Labeler Code

Col. 90-93 - National Drug Code Product Code

Col. 94-99 - FDA Application Number

Col. 100-105 - Report Date

Col. 106 - Type Rprt - Leave blank

Col. 107-111 - Type of Business

Col. 112-116 - Product Type

Col. 117 - BNDD - Leave blank

Col. 118 - Legal Status

Col. 119 - DEA Schedule

Col. 120-125 - Leave blank

Col. 126-140 - Basis of Concentration, in Col. 133 - Whole Numbers - enter 1, Col 134-137 - Decimal - leave blank, and in Col. 138-140 - Unit - enter KIT

Col. 141-143 - Dosage Form, enter KIT

Col. 144-147 - Routes of Administration, enter MISC

Col. 148-156 - Leave blank

Col. 157-158 - PT, enter 1 to represent the kit

Col. 159-164 - Initial Marketing Date

Col. 165-170 - Most Recent Marketing Date

Col. 171-176 - Discontinued Date - Leave blank

Section 03

Col. 18-20 - Leave blank

Col. 21-22 - Package Code

Col. 23-47 - Package Size

Col. 48-72 - Write the words "combination package"

Section 05

Col. 18-20 - Leave blank

Col. 21-22 - PT, enter 1

Col. 44-107 - Ingredient Information - If the kit has non-drug components, enter the words "non-drug components" on the first line. If the kit has drug components only, enter"Drugs only.".

Section 07

Col. 20-84 - Manufacturing information - Manufacturer/repacker's name, labeler code, state, and establishment registration number must be filled in or form will be returned.

Col. 85-99 - Leave blank

Information Pertaining to each drug Component in the Kit

Fill out a Form FDA 2657 for each drug component following instructions starting at the beginning of this chapter. Include the page number at the bottom right of the form. Subsequent Form FDA 2657's for the remaining parts in the kit will include the same type information as above. Exceptions are below:

Section 01

Col. 84-93 - National Drug Code Labeler and Product codes for the kit

Col. 100-105 - Report Date

Col. 126-140 - Basis of Concentration for the drug component

Col. 141-143 - Dosage Form of the drug component in the kit

Col. 144-147 - Routes of Administration for the drug component

Col. 157-158 - PT, enter 2 to represent the drug component

Section 05

Col. 20 - Enter Type of ingredient (A=Active, I=Inactive)

Col. 21-22 - PT, enter 2 to represent the drug component

Col. 44-107 - Ingredients for the drug component.

Col. 29-43 - Amount information for the ingredients

Enter the package size and package type information in Section 03.

Section 07

Col. 20-84 - Only use this section if the manufacturer of the first drug component is different than for the kit.