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U.S. Department of Health and Human Services

Drugs

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Orange Book Data Files

 

  • Downloadable Data Files for the Orange Book
    The the compressed (ZIP) data file unzips into three files, whose field descriptions appear below. All three files are in ASCII text, tilde (~) delimited format.
     
  • The Orange Book Appendices are available in PDF format. 

  • Orange Book Search
    You can search by active ingredient, proprietary name, applicant, or application number. 
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Data Files and Orange Book Appendices

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Data Descriptions

  1. Products.txt

    • 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 Type
      The type of new drug application approval.  New Drug Applications (NDA or innovator)  are ”N”. Abbreviated New Drug Applications (ANDA or generic) are “A”.
    • 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

    • New Drug Application Type
      The type of new drug application approval.  New Drug Applications (NDA or innovator)  are ”N”.   Abbreviated New Drug Applications (ANDA or generic) are “A”.
    • 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

    • New Drug Application Type
      The type of new drug application approval. New Drug Applications (NDA or innovator) are ”N”. Abbreviated New Drug Applications (ANDA or generic) are “A”.
    • 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.

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Orange Book Publications and Help Files

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