Quick answers
- What is Tenofovir disoproxil fumarate used for?
- The FDA-approved label (Viread, Gilead Sciences, Inc., February 18, 2025) says: “VIREAD is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. for the treatment of chronic hepatitis B in adults and pediatric patients 2 years and older weighing at least 10 kg. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tenofovir disoproxil fumarate have a boxed warning?
- Yes. The FDA label for Viread has a boxed warning (“WARNING: POSTTREATMENT 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 Tenofovir disoproxil fumarate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tenofovir disoproxil fumarate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Tenofovir disoproxil fumarate?
- 16 companies list prescription products of Tenofovir disoproxil fumarate in the FDA NDC Directory, including Gilead Sciences, Inc., Aurobindo Pharma Limited and Bryant Ranch Prepack.
What Tenofovir disoproxil fumarate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
VIREAD is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. for the treatment of chronic hepatitis B in adults and pediatric patients 2 years and older weighing at least 10 kg. …
— FDA label: Viread, Gilead Sciences, Inc., effective February 18, 2025. Read the full label on DailyMed →
The FDA has 18 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. Its heading: WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B
. Read it on the full label →
18 of 18 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet, coated · Tablet · Powder |
|---|---|
| Route | Oral |
| Prescription products | 25 in the FDA NDC Directory |
| Brand names | Viread |
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 |
|---|---|---|
| tenofovir disoproxil fumarate 300 mg tablet | Generic | $0.2957 per tablet |
| tenofovir disoproxil fumarate 300 mg tablet, coated | Generic | $0.2957 per tablet |
| tenofovir disoproxil fumarate 300 mg tablet, coated | Brand: Viread | $40.68 per tablet |
| tenofovir disoproxil fumarate 300 mg tablet, film coated | Generic | $0.2957 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.
- Gilead Sciences, Inc.5 products
- Aurobindo Pharma Limited4 products
- Bryant Ranch Prepack3 products
- AvKARE1 product
- Strides Pharma Science Limited1 product
- Major Pharmaceuticals1 product
- Macleods Pharmaceuticals Limited1 product
- PD-Rx Pharmaceuticals, Inc.1 product
- NorthStar RxLLC1 product
- Quinn Pharmaceuticals1 product
- Camber Pharmaceuticals, Inc.1 product
- Chartwell RX, LLC1 product
- AvPAK1 product
- Cipla USA Inc.1 product
- Florida Pharmaceutical Products, LLC1 product
- A-S Medication Solutions1 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 |
|---|---|---|---|
| NDA021356 VIREAD | Gilead Sciences Inc | October 26, 2001 | 35, latest April 24, 2019 2019: Labeling · 2018: Efficacy · 2018: Labeling |
| NDA022577 VIREAD | Gilead Sciences Inc | January 18, 2012 | 12, latest April 24, 2019 2019: Labeling · 2018: Efficacy · 2018: Labeling |
Generic approvals (7)
- ANDA078800Cipla · January 26, 2018
- ANDA090636Hetero Labs Ltd III · January 26, 2018
- ANDA090647Aurobindo Pharma · January 26, 2018
- ANDA090742Strides Pharma · January 26, 2018
- ANDA203232Macleods Pharms · January 26, 2018
- ANDA209498Qilu · March 2, 2018
- ANDA206481Chartwell · July 31, 2018
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Viread, Gilead Sciences, Inc., effective February 18, 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 →