Quick answers
- What is Darunavir, cobicistat, emtricitabine, and tenofovir alafenamide used for?
- The FDA-approved label (Symtuza, Janssen Products LP, April 17, 2026) says: “1. INDICATIONS AND USAGE SYMTUZA is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 40 kg …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Darunavir, cobicistat, emtricitabine, and tenofovir alafenamide have a boxed warning?
- Yes. The FDA label for Symtuza has a boxed warning (“WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Darunavir, cobicistat, emtricitabine, and tenofovir alafenamide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Darunavir, cobicistat, emtricitabine, and tenofovir alafenamide been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Darunavir, cobicistat, emtricitabine, and tenofovir alafenamide?
- 1 company lists prescription products of Darunavir, cobicistat, emtricitabine, and tenofovir alafenamide in the FDA NDC Directory, including Janssen Products, LP.
What Darunavir, cobicistat, emtricitabine, and tenofovir alafenamide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
1. INDICATIONS AND USAGE SYMTUZA is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 40 kg …
— FDA label: Symtuza, Janssen Products LP, effective April 17, 2026. Read the full label on DailyMed →
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.
This label has a boxed warning. Its heading: WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
. Read it on the full label →
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Symtuza |
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 |
|---|---|---|
| cobicistat 150 mg · darunavir 800 mg · emtricitabine 200 mg · tenofovir alafenamide 10 mg tablet, film coated | Brand: Symtuza | $152.85 per tablet |
NADAC list of November 4, 2026; these prices took effect on 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, LP1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA210455 SYMTUZA | Janssen Prods | July 17, 2018 | 10, latest March 31, 2023 2023: Labeling · 2022: Labeling · 2022: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2049671, 2049677 |
|---|---|
| SPL set ID of the quoted label | 85a17d00-6b7c-41ea-a6b3-5ad924820dab |
| FDA labels (SPL) | 1 |
| FDA applications | NDA210455 |
| Active ingredients (FDA) | COBICISTAT / DARUNAVIR / EMTRICITABINE / TENOFOVIR ALAFENAMIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Symtuza, Janssen Products LP, effective April 17, 2026; 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 →