Quick answers
- What is Emtricitabine and tenofovir disoproxil fumarate used for?
- The FDA-approved label (Truvada, Gilead Sciences, Inc, July 16, 2025) says: “HIV-1 Treatment TRUVADA is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg. HIV-1 PrEP …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Emtricitabine and tenofovir disoproxil fumarate have a boxed warning?
- Yes. The FDA label for Truvada has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Emtricitabine and tenofovir disoproxil fumarate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Emtricitabine and tenofovir disoproxil fumarate been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started September 30, 2014 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Emtricitabine and tenofovir disoproxil fumarate?
- 26 companies list prescription products of Emtricitabine and tenofovir disoproxil fumarate in the FDA NDC Directory, including Amneal Pharmaceuticals NY LLC, Gilead Sciences, Inc. and Zydus Pharmaceuticals USA Inc..
What Emtricitabine and tenofovir disoproxil fumarate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
HIV-1 Treatment TRUVADA is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg. HIV-1 PrEP …
— FDA label: Truvada, Gilead Sciences, Inc, effective July 16, 2025. Read the full label on DailyMed →
The FDA has 35 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.
This label has a boxed warning. Read it on the full label →
33 of 35 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 49 in the FDA NDC Directory |
| Brand names | Truvada |
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 |
|---|---|---|
| emtricitabine 100 mg · tenofovir disoproxil fumarate 150 mg tablet, film coated | Generic | $10.19 per tablet |
| emtricitabine 200 mg · tenofovir disoproxil fumarate 300 mg tablet, film coated | Generic | $0.5264 per tablet |
| emtricitabine 200 mg · tenofovir disoproxil fumarate 300 mg tablet, film coated | Brand: Truvada | $59.59 per tablet |
NADAC list of November 4, 2026; these prices took effect between April 22, 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.
- Amneal Pharmaceuticals NY LLC5 products
- Gilead Sciences, Inc.4 products
- Zydus Pharmaceuticals USA Inc.4 products
- Zydus Lifesciences Limited4 products
- Aurobindo Pharma Limited4 products
- NuCare Pharmaceuticals, Inc.4 products
- A-S Medication Solutions3 products
- Proficient Rx LP2 products
- Cipla USA Inc.2 products
- NorthStar RxLLC1 product
- Direct_Rx1 product
- Strides Pharma Inc.1 product
- Major Pharmaceuticals1 product
- Bryant Ranch Prepack1 product
- AvKARE1 product
- Lupin Pharmaceuticals, Inc.1 product
- DirectRx1 product
- Teva Pharmaceuticals USA, Inc.1 product
- Laurus Labs Limited1 product
- Camber Pharmaceuticals, Inc.1 product
- Exelan Pharmaceuticals Inc.1 product
- Macleods Pharmaceuticals Limited1 product
- Golden State Medical Supply, Inc.1 product
- Strides Pharma Science Limited1 product
- Quallent Pharmaceuticals Health LLC1 product
- Redpharm Drug1 product
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 |
|---|---|---|---|
| NDA021752 TRUVADA | Gilead | August 2, 2004 | 32, latest April 29, 2024 2024: Labeling · 2023: Manufacturing (CMC) · 2020: Labeling |
Generic approvals (11)
- ANDA090894Teva Pharms USA · June 8, 2017
- ANDA090513Aurobindo Pharma · January 26, 2018
- ANDA209721Amneal Pharms Co · August 22, 2018
- ANDA212114Laurus · July 26, 2019
- ANDA212689Zydus Pharms · February 28, 2020
- ANDA203442Macleods Pharms · May 15, 2020
- ANDA091055Strides Pharma · January 13, 2021
- ANDA090958Cipla · April 2, 2021
- ANDA204131Chartwell Rx · June 4, 2021
- ANDA201806Hetero Labs Ltd III · October 7, 2021
- ANDA211640Aurobindo Pharma Ltd · March 9, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
September 30, 2014 · Class III · Terminated · D-0013-2015
Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, Rx only, Manufactured for Gilead Sciences, Inc. Foster City, CA 94404, NDC 61958-0701-1 — Gilead Sciences, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Truvada, Gilead Sciences, Inc, effective July 16, 2025; 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 →