Registered Establishments' Report of
Private Label Distributors
Form FDA 2658

This form is used by manufacturers reporting listing information for those private label distributors that do not elect to submit listing information directly to FDA. There must be a Form FDA 2658 for each product processed for one or more firms and sold under the private label distributor's trade names. This form is also used to provide updates to product listing information every June and December or at the discretion of the manufacturer, when any change occurs. We recommend submitting forms as soon as possible once a change occurs so that the information on prescription drug products can be correctly reflected in the National Drug Code Directory.

Initial Drug Product Listing - Form FDA 2658

Form FDA 2658 (Registered Establishment’ Report of Private Label Distributors) is currently available on the Internet. This form can be obtained from www.hhs.gov/forms

F Print or type all entries in English.

F Use additional copies of this form for supplemental pages if necessary. Indicate sequential page numbers on the lower right hand corner, if additional pages are used. Supply the following data on all additional pages: full name and address of the reporting firm, Labeler Code and Product Code numbers.

F Do not write any information in the "FDA USE ONLY" fields.

FAll submissions should include current labels and/or package inserts. Do not submit plastic or glass containers.  

F The Company must provide complete and accurate information on the Form FDA 2658 for a product to be listed by the Agency. A prescription drug product does not appear in the National Drug Code directory, if the submission is incomplete.

Line 1 - (unnumbered)

Col. 1-5 - Control No. FOR FDA USE - (Leave Blank)

Col. 272/27-311 - Reporting Firm - Enter the full name of the reporting firm (manufacturer). This should be the same as shown on Form FDA 2656 for the reporting firm. Abbreviate if necessary but NO punctuation.

Col. 312/20-318 - Establishment Registration No. - Enter the Drug Establishment Number for the manufacturing site of the product.

Col. 251/79-256 - Reporting Firm NDC Code - Enter the Registered Establishment's National Drug Code (NDC) Labeler and Product Code for the identical product listed on Form FDA 2657.

Line 2 - Site Address

Col. 101-138 - Number and Street - Enter street number and name or rural route number of the actual location of the site.

Col. 139-158 - City - Enter the city of the actual location of the site.

Col. 159-160 - State - Enter the two-letter state abbreviation used by the U.S. Postal Service. (See Annex C for abbreviations.)

Col. 161-165 - Zip Code - Enter the zip code of the actual location of the site.

Col. 166-175 - Foreign Country - (Leave Blank)

Col. 14/100 - Rprt Date - (Report Date) - Enter the month and year in which you completed this form using leading zeros where necessary.

Line 3 - Mailing Address

If the mailing address is different from the site address, complete each field of Line 3 using the same instructions as for the site address. (All correspondence regarding the products listed on this form will be sent to the Site Address or to the mailing address, if different.)

Line 4

Col. 6-15 - Record ID FOR FDA USE - (Leave Blank)

Section 01

Col. 16-17 - SEC - Preprinted with 1

Col. 18 - S - (Leave Blank)

Col 19 - U - This is an update field. To discontinue a product, enter a "D" and complete Line 1 (unnumbered), Line 2 and Line 3; and Line 4, Col. 20-83; and, Line 5 Col 40/84-93 of SEC 01. A product name change requires a new NDC Product Code and a new listing.

Col. 20-83 - Trade Name or established Name under which Product is Marketed by Another Firm - Enter the trade name of the product as it appears on the label into the allotted space. Use acceptable abbreviations when the trade name exceeds spaces.

Exclude, as part of the product name, USP, NF, or firm name.

Leave one space between words and no punctuation.

Line 5

Col. 40/84 - NDC Code - Enter the National Drug Code Labeler Code assigned by the FDA to the private label distributor of the drug product being listed. Enter the product code obtained from the private label distributor for the product. (For more information on how to assign product code numbers, see instructions under Drug Product Listing Form FDA 2657, Col 90-93-National Drug Code Product Code)

Col. 46-60 - Short Name - (Leave Blank)

Col. 61-100 - Firm Name on Label - Enter the name of the firm distributing the drug product listed on the previous line.

Section 03

Col. 16-17 - SEC. - Preprinted 3

Col. 21-22 - Package Code - Enter the package codes obtained from the private label distributor for the product. Space has been provided for 5 package codes. Use additional forms for entering additional package codes.

Col. Unnumbered - Zip Code - Enter the zip code for the distributors site location.

How to update Product Listing Information

After submitting initial drug listing information, manufacturers reporting listing information for those private label distributors must update their listing information by using Form FDA 2658 every June and December, or at the discretion of the registrant, when any change occurs, in accordance with section 510 of the Act and 21 CFR part 207. We recommend submitting forms as soon as possible once a change occurs so that the information on prescription drug products can be correctly reflected in the National Drug Code Directory.

To report any changes to listing information, registrants and private label distributors should complete the following fields on Form FDA 2658:

· Reporting Firm Name and Address

· Reporting Firm National Drug Code (Labeler, Product)

· Other sections of the form where changes have occurred