What is the purpose of the Orange Book?

The Orange Book, officially known as the “Approved Drug Products with Therapeutic Equivalence Evaluations,” is a publication provided by the FDA that serves a specific and critical role in the pharmaceutical industry. Its primary purpose is to list drug products that have been approved by the FDA, along with their therapeutic evaluations. This includes information on both brand-name and generic medications, as well as their therapeutic equivalence.

Healthcare providers and pharmacists use the Orange Book to determine whether a generic drug is therapeutically equivalent to its brand-name counterpart, which is crucial for ensuring that patients receive safe and effective treatments. By providing detailed evaluations of these drug products, the Orange Book helps to maintain standards of quality and safety within the field of medication therapy, fostering confidence among prescribers and patients in the use of approved generics.

This publication does not focus solely on over-the-counter medications, nor does it function as a dangerous drug inventory list or a guide for emergency prescribing, which is why those options do not accurately represent the Orange Book's purpose.