Quick answers
- What is Emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate used for?
- The FDA-approved label (Complera, Gilead Sciences, Inc., July 16, 2025) says: “COMPLERA ® is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy or to replace a stable antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate have a boxed warning?
- Yes. The FDA label for Complera 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 Emtricitabine, rilpivirine hydrochloride, 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, rilpivirine hydrochloride, 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 Emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate?
- 3 companies list prescription products of Emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate in the FDA NDC Directory, including Gilead Sciences, Inc., Mylan Pharmaceuticals Inc. and Laurus Labs Limited.
What Emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
COMPLERA ® is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy or to replace a stable antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a …
— FDA label: Complera, Gilead Sciences, Inc., effective July 16, 2025. Read the full label on DailyMed →
The FDA has 3 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 →
3 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Complera |
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 200 mg · rilpivirine hydrochloride 25 mg · tenofovir disoproxil fumarate 300 mg tablet, film coated | Generic | $88.79 per tablet |
| emtricitabine 200 mg · rilpivirine hydrochloride 25 mg · tenofovir disoproxil fumarate 300 mg tablet, film coated | Brand: Complera | $130.15 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.1 product
- Mylan Pharmaceuticals Inc.1 product
- Laurus Labs Limited1 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 |
|---|---|---|---|
| NDA202123 COMPLERA | Gilead Sciences Inc | August 10, 2011 | 21, latest November 27, 2019 2019: Labeling · 2018: Efficacy · 2017: Labeling |
Generic approvals (2)
- ANDA208452Mylan · May 20, 2025
- ANDA220232Laurus · March 4, 2026
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) | 1147334, 1147337 |
|---|---|
| SPL set ID of the quoted label | d637cfab-f1e8-4eb3-a1b3-f85ca3bec612 |
| FDA labels (SPL) | 3 |
| FDA applications | NDA202123, 2 ANDA |
| Active ingredients (FDA) | EMTRICITABINE / RILPIVIRINE / TENOFOVIR DISOPROXIL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Complera, 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 →