What primarily determines the sub-rating of a product in the Orange Book?

The sub-rating of a product in the Orange Book is primarily determined by the dosage form. The Orange Book, officially known as the Approved Drug Products with Therapeutic Equivalence Evaluations, provides information on approved drug products and includes evaluations of their therapeutic equivalence. The dosage form is essential in this context because it influences how the active ingredient is delivered and absorbed by the body, which directly affects its therapeutic effectiveness.

Different dosage forms, such as tablets, capsules, injectables, or topical formulations, are evaluated and rated separately, reflecting their specific properties and clinical relevance. For example, even if two products contain the same active ingredient, their therapeutic equivalence may differ depending on the dosage form. Thus, while factors such as active ingredient concentration, therapeutic effectiveness, and potential side effects are important in assessing a product's overall profile, the dosage form is the primary determinant of its sub-rating in the Orange Book.