Orange Book: What It Is and Why It Matters for Generic Drugs

When you buy a generic pill, how do you know it’s just as safe and effective as the brand-name version? That’s where the Orange Book, the U.S. Food and Drug Administration’s official list of approved drug products with therapeutic equivalence evaluations. Also known as Approved Drug Products with Therapeutic Equivalence Evaluations, it’s the go-to resource for doctors, pharmacists, and anyone who wants to make sure their generic medication works the same way as the original. It’s not a fancy publication—it’s a plain, practical database updated daily, and it’s the reason you can trust that your $5 generic version of Lipitor or Metformin won’t let you down.

The Orange Book doesn’t just list drugs. It rates them. Each approved generic gets a code—like AB—that tells you it’s therapeutically equivalent to the brand. That means the same active ingredient, same dose, same way it’s absorbed by your body. If it’s not AB-rated, it might not work the same, and the Orange Book flags that. You’ll also find patent and exclusivity info here, which explains why some generics aren’t available yet. This is why you can’t buy a generic version of every drug the day it launches—it’s not about supply, it’s about legal timing, and the Orange Book tracks it all.

Related entities like therapeutic equivalence, FDA drug approvals, and generic drug listings are all tied directly to the Orange Book. It’s the backbone of how the U.S. keeps generic drugs safe and affordable. If you’re comparing medications like Cephalexin vs. Amoxicillin, or checking if your generic Prozac is really the same as the brand, the Orange Book is where the official answer lives. It’s not something you need to read cover to cover—but you should know it exists, and how to use it when you’re making choices about your prescriptions.

Below, you’ll find real-world guides that connect directly to what’s in the Orange Book. Whether you’re comparing antibiotics, figuring out which PPI works best, or learning how to safely buy generic meds online, every post here is built on the same foundation: reliable, approved drug data. You’re not just reading about drugs—you’re reading about how we know they work, and why you can trust them.