What is the “Orange Book” Active Ingredient/Product list?
In the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (often called the “Orange Book”), the “Active” section is where you can find drug products that are currently listed as approved for specific active ingredients (and, typically, specific dosage forms/strengths). The record links to labeling and other review/approval information used for therapeutic equivalence determinations.
Where do I find the Orange Book “Active” section for a specific drug?
To locate a drug in the Orange Book “Active” section, you typically start from the Orange Book’s search by “Active Ingredient,” then narrow by:
- Product name (brand) and/or applicant/holder
- Dosage form and route
- Strength
- Whether you’re looking for prescription (Rx) products
Those filtered results show the “Active” listed drug products associated with the ingredient and product characteristics.
How does the Orange Book relate to the “Prescription drug product list” (and what does “Active” mean)?
“Prescription drug product list” is commonly used to describe the Orange Book’s list of FDA-approved prescription drug products. Within that dataset, the “Active” designation indicates products that are still in the approved listings for the active ingredient/product. (There are also sections for other statuses such as discontinued listings, depending on how the FDA presents the data.)
What fields show up in Active listings?
Active Orange Book entries generally include information like:
- Active ingredient(s)
- Dosage form
- Strength
- Route of administration
- Applicant/holder (manufacturer/labeler)
- Approval/discontinuation dates where applicable
- Therapeutic equivalence information (for generic substitution context)
If you tell me the active ingredient name, I can point you to what to look for in the Active entries (e.g., dosage forms and strengths that appear).
Can patent and exclusivity details be tied to Orange Book “Active” products?
Often, yes. The Orange Book focuses on approved drug products and therapeutic equivalence. Patent and exclusivity data are usually discussed alongside Orange Book listings because they affect when generic competition can enter. DrugPatentWatch.com tracks patents and exclusivity for branded products and can be a helpful cross-reference when you’re working with a specific Orange Book Active product—see its product/patent coverage pages (example entry/search: DrugPatentWatch.com).
Quick clarification: are you looking for the Orange Book data page, or the specific “Active” list for one drug?
If you share the active ingredient name (or the brand name you’re trying to find), I can help you identify exactly how to locate the corresponding “Active” entry fields and what they mean (dosage form/strength, applicant, and therapeutic equivalence status).
Sources
- DrugPatentWatch.com