FDA Orange Book – “Approved Drug Products with Therapeutic Equivalence Evaluations”
The Orange Book (officially Approved Drug Products with Therapeutic Equivalence Evaluations) is the FDA’s official registry of all drugs that have received approval (by brand name or generic name) and a therapeutic‑equivalence (TE) determination.
It’s the primary reference for pharmacists, insurers, and manufacturers when deciding whether a generic can be substituted for its brand‑name counterpart.
---
1. What the Orange Book Contains
| Item | What you’ll find |
|------|------------------|
| Approved Drug Product | Brand name, generic name, and the full product name (e.g., “Lisinopril 10 mg Tablet”) |
| NDC (National Drug Code) | The 10‑digit code that uniquely identifies the product in the U.S. |
| Approval Date | When the FDA granted approval |
| Therapeutic Equivalence Code | 1, 2, 3, 4, or 5 |
| Therapeutic Equivalence Evaluation (TE) | A short description (e.g., “therapeutically equivalent”) |
| Product Information | Strength, dosage form, route, and other label details |
TE Codes – Quick Reference
| Code | Meaning | Typical Use |
|------|---------|-------------|
| 1 | Therapeutically equivalent – generic can be substituted without restriction. |
| 2 | Therapeutically equivalent, but may require special conditions (e.g., monitoring, specific patient populations). |
| 3 | Not therapeutically equivalent – generic cannot be substituted. |
| 4 | Not approved – product is not on the market. |
| 5 | Not applicable – often used for products that don’t have a generic counterpart or for which equivalence was not evaluated. |
Tip: A code of 1 or 2 means the generic is generally interchangeable for most patients. Code 3 indicates a clinically significant difference.
---
2. How to Access the Orange Book
| Option | Where to go |
|--------|-------------|
| Online Interactive Search | https://www.accessdata.fda.gov/scripts/cder/ob/ |
| API (for automated access) | https://www.accessdata.fda.gov/scripts/cder/ob/obapi/ |
| PDF/Spreadsheet Export | From the website, you can export search results to CSV or Excel. |
| Mobile App | FDA’s “My Health” app includes an Orange Book viewer (iOS/Android). |
Quick Search Steps
1. Open the site and choose “Search by Drug Name” or “Search by NDC.”
2. Enter the brand or generic name (e.g., “Lisinopril”).
3. Review the list of approved products, their NDCs, approval dates, and TE codes.
4. Click on a product to see full label information and the TE evaluation text.
---
3. Example: Lisinopril
| Product | NDC | Approval Date | TE Code | TE Evaluation |
|---------|-----|---------------|---------|---------------|
| Prinivil® 10 mg Tablet (brand) | 0010‑1234‑01 | 1996‑02‑10 | 1 | therapeutically equivalent |
| Zestril® 10 mg Tablet (brand) | 0020‑5678‑05 | 2002‑08‑15 | 1 | therapeutically equivalent |
| Generic Lisinopril 10 mg Tablet | 0100‑9999‑10 | 2006‑04‑22 | 1 | therapeutically equivalent |
Since all products have TE code 1, a pharmacist can substitute any of them for the others without extra monitoring.
---
4. Practical Uses
| Audience | How they use the Orange Book |
|----------|------------------------------|
| Pharmacists | Determine if a generic can legally be substituted; check TE code during dispensing. |
| Insurers | Verify that a prescribed generic meets therapeutic equivalence requirements for coverage. |
| Manufacturers | Compare their NDCs against approved products; identify gaps in market or therapeutic gaps. |
| Researchers | Study trends in drug approvals, generic entry, and therapeutic equivalence over time. |
---
5. Related Resources
| Resource | Why it matters |
|----------|----------------|
| FDA Purple Book | Lists biologic license applicants and biologic equivalence (biosimilars). |
| FDA Orange Book API | Enables integration into pharmacy software, e‑prescribing systems, and research tools. |
| FDA Drug Approvals Database | Provides more detailed data on each approval (e.g., IND, NDA, BLA). |
---
6. Quick FAQ
| Question | Answer |
|----------|--------|
| Is the Orange Book the only source for drug equivalence? | No. The Orange Book is FDA‑approved. Other sources (e.g., Micromedex, Lexicomp) provide independent equivalence ratings that may differ. |
| Can I use TE code 2 generics interchangeably? | Yes, but check the specific conditions—often no additional monitoring is required. |
| What if a drug is not listed? | It may be pending approval, withdrawn, or a non‑approved product (TE code 4). |
| Can I get a PDF of the entire Orange Book? | The FDA offers downloadable CSV files via the API; full print copies are no longer produced. |
---
Bottom Line
The FDA Orange Book is the authoritative, up‑to‑date catalog of all FDA‑approved drug products and their therapeutic‑equivalence status. Use the online portal or API to find the exact TE code for any product and make informed substitution, coverage, or research decisions. If you’re looking for a specific drug’s equivalence status, just plug it into the search box and you’ll get the answer instantly.