Drug Product Listing
Form FDA 2657

This form is used by all registrants to submit a listing for every product in commercial distribution, and private label distributors who elect to submit listing information to FDA for products they distribute. This form is also used to provide updates to product listing information every June and December or at the discretion of the registrant, 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. There are five basic reasons for submitting this form:

Initial Drug Product Listing - Form FDA 2657

Form FDA 2657 (Drug Product Listing) 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 A Sample Form FDA 2657 for Gas Companies is available for use.     

F The Company must provide complete and accurate information on the Form FDA 2657 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.

 Col. Unnumbered - Name and Site Address of Firm. Enter the firm’s full name and the compliance address. (Form deficiencies will be mailed to this address. However, all deficiencies for foreign firms will be mailed to US agents address.)

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

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

Section 01

Col. 16-17 - Sec 01 - Preprinted

Col. 18 - S - (Leave Blank)

Col. 19 - U - Update. Use to indicate a change in information previously submitted. Use the following codes:

 Col. 20-83 - Product Trade Name - Enter the trade name of the product as it appears on the label in these 64 spaces. Use acceptable abbreviations when the trade name is too long. Do not include, the USP, NF, or firm name. Leave one space between words. Punctuation is NOT allowed.

Col. 84-89 - National Drug Code Labeler Code - Using leading zeros, enter the 4-digit or the 5-digit National Drug Code (NDC) Labeler code (assigned by FDA) for the firm. Enter the last digit of the code in Col. 89. If no code has been assigned, leave the field blank. (If you are a first time registrant and no code has been assigned, form FDA 2656 must be submitted to obtain a Labeler code number).

Col. 90-93 - National Drug Code Product Code - The product code uniquely identifies the drug product formulation of an individual firm. If a 4-digit NDC labeler code has been assigned, use the 4-digit product code/2-digit package code configuration for all products. When a 5-digit Labeler Code has been assigned, choose either of the following Product/Package Code configurations:

3-digit Product Code/2-digit Package Code
or
4-digit Product Code/1-digit Package Code

All positions must be filled in the NDC Product field (Col. 84-93). So, when entering 3-digit product codes, insert an asterisk (*) in the left-most position (Col. 90). Example: *463. When entering 4-digit product code, enter 0463 beginning in the left-most position (Col. 90) (A firm can assign up to a 1000 product code numbers and up to 100 package code numbers by choosing 5-3-2 configuration and can assign up to 10,000 product code numbers and up to 10 package code numbers by choosing 5-4-1 configuration).

NOTE: Once a Product/Package Code configuration is chosen, the same configuration must be used in assigning the Product/Package Code for all drugs listed. Only one product code to specific drug formulation and dosage form should be assigned. If a change only in the trade package is involved, add a new package code without assigning a new product code.

If the product name, dosage form, strength, concentration, or an active ingredient is changed, the original product must be discontinued on the Form FDA 2657 and a second Form FDA 2657 must be submitted to list the new product with a new product code.

Col. 94-99 - FDA Application No. - If this is a prescription product, enter the New Drug Application (NDA), or the abbreviated New Drug Application Number (ANDA), or Biologic License Application Number (BLA) which has been approved for the product in commercial distribution. Enter the number with the last digit in the right-most position using leading zeros when necessary. Do not use hyphens (-). The  NDA/ANDA/BLA number is a required number that is needed to complete the listing of the product.  If you do not have a  NDA/ANDA/BLA number or have not applied for and received one write "NONE" in this field, and your product will be filed as pending, unless:

 

(a) You submit the product's NDA, ANDA, or BLA number      

(b)  You declare that the drug product is in compliance with the pre-1938/1962 grandfather provisions, you will need to submit documentation to justify your claim that your product does not need an approved application prior to marketing, if requested by the agency, 

(c)  Product is subject to a pending DESI Less-than-Effective Federal Register notices,

(d)  Product is an Active Pharmaceutical Ingredient (API)

(e)  Product is a homeopathic product,

 (f) Product is a medical gas,

(g) A kit that does not require an approved application.    

If your product is an over-the-counter (OTC) product, enter the Monograph number (21 CFR paragraph number in which monograph has been published).   If your OTC product is not covered by a final OTC Monograph, write "NONE."  Your OTC product will be filed as pending until you submit the appropriate Monograph number or an Approved Application Number.

Col. 100-105 - Report Date - Enter the month, day and year on which this form is completed. Example: If completed on May 15, 1993, the entry would be: 51593

Col.106 - Type Report - (Leave Blank)

Col. 107-111 - Type of Business - Enter one or more of the following codes to indicate the business function as it relates to the listed drug: (Start in Col. 107)

Codes

If the business type is not included in the above list, specify the type in the space right of Col. 111 ("Other").

Col. 112-116 - Product Type - Enter one or more of the following codes. (Start in Col. 112)

Codes

Col. 117 - BNDD - (Leave Blank)

Col. 118 - Legal Status - Enter an O (OTC Drug), R (Prescription Drug) or I (Investigational Drug).

Col. 119 - Sched (DEA Schedule) - If the product is a scheduled drug, enter the appropriate number 1 through 5 to indicate the current DEA schedule for the product, as defined in the Comprehensive Drug Abuse Prevention and Control Act of 1970.

Col. 120 - Prof Use - An optional category for use on products whose labeling carries statements such as "For Professional Use Only," "For Prescription Compounding," etc. If this applicable, enter the letter P.

Col. 121-125 - Reason Product Discontinued - Enter one of the following codes, starting in Col. 121. If none of these codes is applicable, specify reason in space titled "Other."

Codes

 Col. Unnumbered - Basis of Concentration - Enter the unit in which the quantity of an ingredient is expressed. If the drug is in unit dosage form (capsule, tablet, or other solid dosage form) enter only the dosage form code. (Use codes in Table I, see Table of Contents). If the drug is not in unit dosage form, the statement of quantity of an ingredient shall express the amount in a specific unit of weight or measurement of a drug (I.E., 5 ml, 1G). Do not use commas when entering whole numbers or decimal points when entering decimal numbers (i.e., enter whole numbers in whole number field and decimal numbers in decimal field).

Col. 126-133 - Whole Numbers - Enter the whole number beginning in the right-most column and working left. For example, if a liquid preparation states on the label that "X" mg of an ingredient is contained in 4.5 ml of the liquid, the number 4 would be placed in Col. 133, and the number 5 would be placed in Col. 134.

Col. 134-137 - Decimal - Enter the decimal part of the number starting in Col 134.

Col. 138-140 - Unit - Enter the unit in which the quantity of an ingredient is expressed. For example, enter ML in the unit field starting in Col. 138.

Col. 141-143 - Dosage Form - Enter the dosage form using codes from Table I , Annex D.

Col. 144-156 - Routes of Administration - Enter the 3 most frequent routes of administration, starting in the left-most column of each field, using codes from Table II, Annex D. If additional routes exist, enter "X" in Col 156, "Other."

Col. 157-158 - PT (Part) - If the product listed is a combination of 2 or more parts, or 2 or more different dosage forms, a form is required for each part or dosage form. Enter 1 in this field for the first part, 2 for the second, etc. The numbers used in these columns must be the same number that is entered in Section 05 PT (Part) field (Col.21-22).

Col. 159-164 - Initial Marketing Date Enter the month and year during which the product submitted on this form was first marketed by your firm Example: Enter July 1962 as 71962

Col. 165-170 - Most Recent Marketing Date - Enter the month and year during which commercial distribution was resumed for previously discontinued product.  Example: Enter July 1973 as 071973

Col. 171-176 - Discontinued Date - Enter the month and year in which commercial distribution of the product was discontinued. Example: Enter May 1967 as 51967.

Section 03

Col. 16-17 - SEC - Preprinted with 03

Col. 18 - S - (Leave Blank)

Col. 19 - U - Use this field when updating package information. Enter the following codes:

When using D, C, or E, enter the package size and type in Col. 23-72. Use C or E to change or correct package size and type but NOT to correct package codes (Col 21-22). When changing package codes, use D to delete the old package code and re-enter the new code, package size and type on a second line.

Col. 20 - Smpl (Sample) - Enter S if the Package Code is for a sample.

Col. 21-22 - Pkg Code (Package Code) - The Package Code is either the final digit or the final set of 2-digits in the 10-digit NDC Code and identifies the package size and type. The Package Code is assigned by the manufacturer or private label distributor. If the package code is a single digit, enter an asterisk (*) in Col.21 and the code number in Col. 22. For domestic bulk drug substances or Active Pharmaceutical Ingredient (API) enter the numeric one or two digits, or 1 or 2 asterisks (**) as the package code in Col. 21-22. (A bulk drug substance or Active Pharmaceutical Ingredient (API) is any substance represented for use in a drug and when in the manufacturing, processing, or packaging of a drug becomes an active ingredient of a finished dosage form. This does not include intermediates used in the synthesis of such substances.)

Col. 23-47 - Package Size - The Package Size entry will describe the unit or number of units which make up a package. A package is an entity which cannot be broken or subdivided. It should be entered as described in the manufacturer's or private label distributor's catalog. Some representative package sizes might be 12's, 24's, 100's, etc., for products like tablets, capsules, and ampules. Representative sizes for liquid preparations might be 30 ml, 120 ml, 8 fluid ounce, etc. Do not use commas when entering amounts and do not punctuate abbreviations. Start all entries in Col. 23. Use additional Forms FDA 2657 if more than 5 package sizes are entered. On each additional page, enter the firm name, address, labeler Code, product Code and number each page at the bottom right.

Col. 48-72 - Package Type - Enter code from Table IV (Annex D) for container in which the product is packaged (i.e., box, bottle, injection, vial, etc.) for each package size. Use additional Forms FDA 2657 if more than 5 package types are entered. On each additional page, enter the firm name, address, labeler Code, product Code and number each page at the bottom right.

 Section 05

Col. 16-17 - SEC - Preprinted with 05

Col. 18 - S - (Leave Blank)

Col. 19 - U - This is an update field and is used for error correction, deletion, or change of data previously submitted in Section 05. Enter one of the following:

When using E, D, or C make sure you enter the data for the other columns on that line.

A change in an active ingredient and/or its labeled amounts, except if in error, requires you to discontinue the product on a Form FDA 2657. Submit a second Form FDA 2657 with an assignment of a new product code.

Col. 20 - Type - Enter the code that describes the type of data being entered per line in Col. 44-107 of Section 05. If an ingredient is expressed in equivalent amount, enter "X" in Col. 20 (see details below under Code X). If an ingredient has two equivalent amounts, enter the first as explained above, and for the second equivalent amount, enter "Y" in Col. 20 (see details under Code Y).

Codes

 

Col. 21-22 - PT (Part) - If the product listed is a combination of two or more components (i.e., two different tablets or a tablet and capsule) enter a 2-digit number in this field for each part of the product beginning with 1. All ingredients for one component would have the same part number. The number used in these columns must be the same numbers entered in Section 01, PT (Part), Col. 157-158). All inactive ingredients should be listed last. Enter part numbers with the last digit in (Col. 22) using leading zeros when necessary.

Col. 44-107 - Ingredient(s), and/or Established Name of Product, and Biologic Proper Name - Starting in Col. 44, enter active ingredient(s), inactive ingredient(s), and biologic proper name(s) starting in Col. 44 using minimum abbreviations, no punctuation and leave one space between words. Use only one line to enter name.

Biologic Proper Names, as established by FDA, should be entered. The term "established name" with respect to a drug or ingredient means:

1. The applicable official name designated pursuant to Section 508 of the Federal Food, Drug and Cosmetic Act.
2. If there is no such name or drug, or the ingredient is an article recognized in an official compendium, then the official title in the compendium will be used.
3. If neither 1 or 2 applies, then the common or usual name, if any, will be used. 

Col. 23-28 - Ingredient No. FOR FDA USE - (Leave Blank)

Col. 29-40 - Amount - Enter the whole number amount of the stated ingredient in Col. 29-36 with the last digit of the number in the right-most column of the field. Enter the decimal part of the number in Col. 37-40 starting in Col. 37.

Enter an amount for an established product name only when applicable.

Col. 41-43 - Unit - Use codes from Annex, D, Table III in this field.

When reporting inactive ingredients which are added in a quantity sufficient to reach a certain measure, enter "QS" in the Unit field starting in Col. 41. When inactive ingredient quantities are not given, enter "NS" in the Unit field in Col. 41.

Section 07

Col. 16-17 - SEC - Preprinted with 07

Col. 18 - S - (Leave Blank)

Col. 19 - U - Update. Use to indicate a change in information previously submitted. To change any data in this section, enter a "D" in Col. 19, and enter the Site or Firm Establishment Reg. No. in Col. 20-26. This will delete the previously submitted line entry. Use the next line to enter the correct information, leaving Col. 19 blank.

Col. 20-26 - Site or Firm Establishment Reg. No. -This is the number assigned by the FDA to each site where the drug product listed is manufactured. If you have no Registration Number, enter the Manufacturing Site Name, address in Col. 27-66. and NDC Labeler Code in Col 79-84.  (Currently registration numbers consists of either 7 digits and/or 10 digits. Use the available space to fill in the 10 digit registration number)

Col. 27-66 - Actual Manufacturing Site of the Above Drug Product - Enter the full name of the manufacturing site and address which corresponds with the Establishment Reg. No. in Col. 20-26.

Col.67-68 - State - Enter the two-letter state code of the U.S. Postal Service states and territories (Section G, Abbreviations) for the manufacturer's site address. For foreign firms leave it blank.

Col. 69-78 - Foreign Country - Enter the foreign country, if applicable, for the site address of the manufacturer. Abbreviate as necessary.

Col. 79-84 - NDC Labeler Code - Enter the National Drug Code (NDC) Labeler Code assigned by FDA to the registered establishment. Enter with the last digit in the right-most column using leading zeros where necessary.

Col. 85-99 - Short Name - (Leave Blank)

How to update Product Listing Information

After submitting initial drug listing information, registrants and, if applicable, private label distributors must update their listing information by using Form FDA 2657 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 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 2657:

· Name and Address of Firm

· Product Trade Name

· National Drug Code (Labeler, Product)

· Other sections of the form where changes have occurred

PRODUCT IMPRINTING

1. What is an imprint code?

A imprint code is defined in 21 CFR 206,10(d) as any single letter or number or any combination of letters and numbers, including, e.g., words, company name, and National Drug Code, or a mark, symbol, logo, or monogram, or a combination of letters, numbers, and marks or symbols, assigned by a drug firm to a specific drug product.

2. What types of drug products does this apply to?

21 CFR Part 206 effective September 13, 1995, applies to all solid oral dosage form human drug products, including prescription drug products, over-the-counter drug products, and homeopathic drug products, unless otherwise exempted under 21 CFR 206.7

3. Imprint information required.

According to 21 CFR 207.25(c) for each drug product listed subject to imprinting requirements, drug companies must submit a document that provides the name of the product, dosage strength, National Drug Code number, its size, shape, color, and imprint code, and any other characteristic that identifies the product as unique. At this time, there is no official form; however, an example format is provided.