How Do I use the Electronic Orange Book to find approved generic drugs?
First, if you have the trade name, search the Electronic Orange Book Rx or OTC section using the Proprietary Name search. This determines the ingredient(s). Then use the Ingredient Search for all approved products that contain the ingredient(s). The resulting list will provide approved products by dosage form and route. For each dosage form; route grouping, there will be a Reference Listed Drug (RLD) that is the innovator product. One or more strengths will have a Yes RLD. If there are approved generic products of another firm, the RLD will be No and all the products within the dosage form; route grouping will have a therapeutic Equivalence Code (TE Code). Products that have been discontinued are in the Discontinued Section and do not RLD or TE Codes. The OTC Section products are not evaluated for therapeutic Equivalence. Refer to the EOB home page preface for discussion and definitions of the TE Code and Reference Listed Drug (RLD). There is also a link on the query column headings wh
