Quick answers
- What is Etravirine used for?
- The FDA-approved label (Intelence, Janssen Products LP, August 15, 2023) says: “INTELENCE, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and pediatric patients 2 years of age and older […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Etravirine have a boxed warning?
- No. None of the 7 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Etravirine?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated April 28, 2026). Ask your pharmacist about alternatives.
- Has Etravirine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Etravirine?
- 7 companies list prescription products of Etravirine in the FDA NDC Directory, including Janssen Products, LP, Amneal Pharmaceuticals NY LLC and Patriot Pharmaceuticals.
What Etravirine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INTELENCE, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and pediatric patients 2 years of age and older […]. …
— FDA label: Intelence, Janssen Products LP, effective August 15, 2023. Read the full label on DailyMed →
The FDA has 7 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 7 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 16 in the FDA NDC Directory |
| Brand names | Intelence |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| etravirine 100 mg tablet | Generic | $7.77 per tablet |
| etravirine 200 mg tablet | Generic | $9.24 per tablet |
| etravirine 200 mg tablet | Brand: Intelence | $24.30 per tablet |
NADAC list of November 4, 2026; these prices took effect between March 18, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Janssen Products, LP3 products
- Amneal Pharmaceuticals NY LLC3 products
- Patriot Pharmaceuticals2 products
- Bionpharma Inc.2 products
- Carnegie Pharmaceuticals LLC2 products
- AvKARE2 products
- Leading Pharma, LLC2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022187 INTELENCE | Janssen R and D | January 18, 2008 | 20, latest July 10, 2019 2019: Labeling · 2018: Efficacy · 2018: Efficacy |
Generic approvals (3)
- ANDA214196Amneal · June 14, 2021
- ANDA215402Pharmobedient · April 13, 2022
- ANDA219152Bionpharma · October 2, 2025
Shortage status
To be discontinued · updated April 28, 2026 · first posted April 28, 2026
| Product | Etravirine, Tablet, 100 mg (NDC 10147-0570-1) |
|---|---|
| Company | Janssen Research and Development |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Intelence, Janssen Products LP, effective August 15, 2023; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →