Orange Book Information Data Files

The Orange Book data files are current through March 2008. Every effort has been made to prevent errors and discrepancies in the Approved Drug Products data files.  However, if you detect an error or discrepancy in drug data, please send a brief description of the data problem to the following e-mail address:  DRUGPRODUCTS@CDER.FDA.GOV.

General questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Drug Information Branch at the following e-mail account: DRUGINFO@FDA.HHS.GOV.

Requests for more specific information should be submitted in writing or directed to the FDA's Freedom of Information Staff at:

Food and Drug Administration
Freedom of Information Office, HFI-35
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 827-6500

The CDER Freedom of Information Office Electronic Reading Room. provides background information about the FOI process.

Electronic Orange Book (EOB) Query data files

The following describes the Approved Drug Products EOB Query web files.  The files are ASCII text tilde (~) delimited.  They are zipped into a self-extracting file, EOBZIP.ZIP or EOBZIP.EXE.  Allow for approximately 5 megabytes for the unzip process.

1.       PRODUCTS.TXT

Tilde (~) delimited Orange Book approved products:

Ingredient


The active ingredient(s) for the product. Multiple ingredients are in alphabetical order separated by a semicolon.

Dosage form;Route of Administration


The product dosage form and route separated by a semi-colon.  The format is not all uppercase.

Trade Name


The trade name of the product as shown on the labeling.

Applicant


The firm name holding legal responsibility for the new drug application.  The firm name is condensed to a maximum twenty character unique string.

Strength


The potency of the active ingredient.  May repeat for multiple part products.

New Drug Application (NDA) Number


The FDA assigned number to the application. Format is nnnnnn.

Product Number


The FDA assigned number to identify the application products. Each strength is a separate product.  May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code


The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date


The date the product was approved as stated in the FDA approval letter to the applicant.  The format is Mmm dd, yyyy.  Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".

Reference Listed Drug (RLD)


The pioneer or innovator of the drug.  The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference.  Format is Yes or No.

Type


The group or category of approved drugs.  Format is RX, OTC, DISCN.           

Applicant Full Name


The full name of the firm holding legal responsibility for the new drug application.

 2.       PATENT.TXT

tilde (~) delimited Orange Book Patent/Exclusivity data files:

New Drug Application (NDA) Number


The FDA assigned number to the application. Format is nnnnnn.

Product Number


The FDA assigned number to identify the application products.  Each strength is a separate product.  May repeat for multiple part products. Format is nnn.

Patent Number


Patent numbers as submitted by the applicant holder for patents covered by the statutory provisions.  May repeat for multiple applications and multiple products. Includes pediatric exclusivity granted by the agency.  Format is nnnnnnnnnnn.

Patent Expire Date


The date the patent expires as submitted by the applicant holder including applicable extensions.  The format is MMM DD, YYYY.

Drug Substance Flag


Patents submitted on FDA Form 3542 and listed after August 18, 2003 may have a drug substance flag indicating the sponsor submitted the patent as claiming the drug substance.   Format is Y or null.

Drug Product Flag


Patents submitted on FDA Form 3542 and listed after August 18, 2003 may have a drug product flag indicating the sponsor submitted the patent as claiming the drug product.   Format is Y or null.  


Patent Use Code


Code to designate a use patent that covers the approved indication or use of a drug product.  May repeat for multiple applications, multiple products and multiple patents.  Format is nnnnnnnnnn.  


Patent Delist Request Flag


Sponsor has requested patent be delisted.  This patent has remained listed because, under Section 505(j)(5)(D)(i) of the Act, a first applicant may retain eligibility for 180-day exclusivity based on a paragraph IV certification to this patent for a certain period.  Applicants under Section 505(b)(2) are not required to certify to patents where this flag is set to Y.  Format is Y or null.

3.      EXCLUSIVITY.TXT

Tilde (~) delimited Orange Book Patent/Exclusivity data files:

New Drug Application (NDA) Number


The FDA assigned number to the application.  Format is nnnnnn.

Product Number


The FDA assigned number to identify the application products. Each strength is a separate product.  May repeat for multiple part products.  Format is nnn.

Exclusivity Code


Code to designate exclusivity granted by the FDA to a drug product.  Format is nnnnnnnnnn.

Exclusivity Date


The date the exclusivity expires. Format is MMM DD, YYYY.

Electronic Orange Book Appendices

1.      APPENDIX A

Product Name Index (Prescription and OTC Drug Product Lists). An index of drug products by established or trade name updated quarterly.

2.     APPENDIX B

Product Name Index Listed by Applicant (Prescription and OTC Product Lists). An index that cross-references applicants to drug products updated quarterly.

3.     APPENDIX C

Uniform terms. Used to designate dosage forms, routes of administration, and abbreviations used to designate strengths.

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Date Updated: May 1, 2008

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