Quick answers
- What is Efavirenz, emtricitabine and tenofovir disoproxil fumarate used for?
- The FDA-approved label (Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate, Bryant Ranch Prepack, November 4, 2025) says: “Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of 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 Efavirenz, emtricitabine and tenofovir disoproxil fumarate have a boxed warning?
- Yes. The FDA label for Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate 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 Efavirenz, 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 Efavirenz, emtricitabine and tenofovir disoproxil fumarate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Efavirenz, emtricitabine and tenofovir disoproxil fumarate?
- 7 companies list prescription products of Efavirenz, emtricitabine and tenofovir disoproxil fumarate in the FDA NDC Directory, including Camber Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc. and Aurobindo Pharma Limited.
What Efavirenz, emtricitabine and tenofovir disoproxil fumarate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg. …
— FDA label: Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate, Bryant Ranch Prepack, effective November 4, 2025. 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.
This label has a boxed warning. Its heading: WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B
. Read it on the full label →
7 of 7 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 7 in the FDA NDC Directory |
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 |
|---|---|---|
| efavirenz 600 mg · emtricitabine 200 mg · tenofovir disoproxil fumarate 300 mg tablet, film coated | Generic | $1.11 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.
- Camber Pharmaceuticals, Inc.1 product
- Teva Pharmaceuticals USA, Inc.1 product
- Aurobindo Pharma Limited1 product
- Cipla USA Inc.1 product
- Bryant Ranch Prepack1 product
- Macleods Pharmaceuticals Limited1 product
- Laurus Labs Limited1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (6)
- ANDA203041Aurobindo Pharma · September 4, 2018
- ANDA091215Teva Pharms USA · November 9, 2018
- ANDA206894Cipla · June 3, 2019
- ANDA204287Macleods Pharms · September 13, 2021
- ANDA213541Laurus · December 22, 2021
- ANDA203053Hetero Labs Ltd V · January 24, 2022
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) | 643066 |
|---|---|
| SPL set ID of the quoted label | ec61f069-632e-4628-b9b1-701d381a1a06 |
| FDA labels (SPL) | 7 |
| FDA applications | 6 ANDA |
| Active ingredients (FDA) | EFAVIRENZ / EMTRICITABINE / TENOFOVIR DISOPROXIL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate, Bryant Ranch Prepack, effective November 4, 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 →