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Emtricitabine, Rilpivirine, and Tenofovir

Emtricitabine, rilpivirine, and tenofovir is a three-drug, once-daily combination pill used as a complete regimen to treat HIV-1 infection in adults and children who weigh enough.

Brand names OdefseyComplera
Drug class Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 8, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 4 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 8, 2026
Emtricitabine, Rilpivirine, and Tenofovir at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Emtricitabine, rilpivirine and tenofovir (Odefsey, Complera) is a once-daily tablet that treats HIV-1 on its own, combining three drugs that block the enzyme the virus needs to copy itself. On the market since about 2011 and available as a generic, it is a well-established option, often used to switch people whose virus is already well controlled. Most people tolerate it well, and headache or trouble sleeping are the usual complaints. Its boxed warning is about hepatitis B, because stopping this medicine can set off a severe liver flare in people who also have hepatitis B, so never stop on your own.

Clinical pearls

  • Take it with a meal every time, because rilpivirine absorbs poorly on an empty stomach.
  • Omeprazole, pantoprazole and similar acid blockers are off-limits; famotidine is fine taken at least 12 hours before or 4 hours after.
  • Antacids like Tums should be taken at least 2 hours before or 4 hours after this medicine.
  • Seizure drugs like carbamazepine and phenytoin, rifampin and St John's wort can drop rilpivirine levels and let the virus rebound.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

If you also have hepatitis B and stop this medicine, your hepatitis B can flare up severely. This can lead to liver failure. It has been reported in people with both HIV-1 and hepatitis B who stopped medicines containing emtricitabine and/or tenofovir disoproxil fumarate.

Do not stop on your own. If you do stop, your liver should be monitored with exams and blood tests for at least several months. Your doctor may start hepatitis B treatment if needed.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet
Earliest FDA record2011
Companies listing it with the FDA3
FDA label last updatedJul 16, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Emtricitabine, Rilpivirine, and Tenofovir, written from its FDA label.

What Emtricitabine, Rilpivirine, and Tenofovir is used for

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This combination treats HIV-1 infection as a complete regimen.

  • Initial treatment in people who have never taken HIV medicine and have HIV-1 RNA of 100,000 copies/mL or less.
  • Replacing a stable regimen in people with suppressed virus (under 50 copies/mL) for at least 6 months, with no treatment failure and no known resistance to its components.
  • Complera and the generic TDF tablets are for adults and children weighing at least 35 kg.
  • Odefsey (with tenofovir alafenamide) is a separate product with its own weight and kidney guidance.

How Emtricitabine, Rilpivirine, and Tenofovir works

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The three drugs block HIV's reverse transcriptase, the enzyme the virus uses to copy its genetic material. Emtricitabine and tenofovir are nucleoside analogs. Rilpivirine is a non-nucleoside inhibitor. Using three together helps keep the virus under control.

Emtricitabine, Rilpivirine, and Tenofovir dosage

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This is a single tablet taken by mouth once a day with food. Take it at about the same time each day.

  • Complera: one tablet daily with food.
  • Odefsey: one tablet daily with a meal.
  • If you take rifabutin, your doctor may add an extra rilpivirine tablet with a meal.

Follow your prescriber's directions and the label. Ask your pharmacist what to do about a missed dose.

Dosing details from the FDA-approved label

From the Emtricitabine, Rilpivirine, and Tenofovir prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Adults and pediatric patients weighing at least 35 kg
    • One tablet taken orally once daily with food
    • Tablet contains 200 mg emtricitabine, 25 mg rilpivirine, and 300 mg tenofovir disoproxil fumarate
  • Pregnant patients already on the tablets prior to pregnancy and virologically suppressed (HIV-1 RNA less than 50 copies per mL)
    • One tablet taken once daily may be continued
    • Lower rilpivirine exposures observed during pregnancy; monitor viral load closely
  • Patients with moderate or severe renal impairment (estimated creatinine clearance below 50 mL per minute)
    • Not recommended
    • Estimated creatinine clearance below 50 mL per minute
  • Coadministration with rifabutin
    • Take an additional 25 mg tablet of rilpivirine (Edurant) once daily with the tablets and with a meal for the duration of the rifabutin coadministration
    • Taken with a meal
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION • Testing: Prior to or when initiating emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets, test for hepatitis B virus infection. Prior to initiation and during treatment with emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. ( 2.1 ) • Recommended dosage in adults and pediatric patients weighing at least 35 kg: One tablet taken orally once daily with food. ( 2.2 ) • For pregnant patients who are already on emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets prior to pregnancy and who are virologically suppressed (HIV-1 RNA less than 50 copies per mL), one tablet taken once daily may be continued. Lower exposures of rilpivirine were observed during pregnancy; therefore, viral load should be monitored closely. ( 2.3 ) • Renal impairment: Not recommended in patients with estimated creatinine clearance below 50 mL per minute. ( 2.4 ) • Recommended dosage with rifabutin coadministration: an additional 25 mg tablet of rilpivirine (Edurant ® ) once per day taken concomitantly with emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets and with a meal for the duration of the rifabutin coadministration. ( 2.5 , 7.6 , 12.3 ) 2.1 Testing Prior to Initiation and During Treatment with Emtricitabine, Rilpivirine and Tenofovir Disoproxil Fumarate Tablets Prior to or when initiating emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets, test patients for hepatitis B virus infection [see Warnings and Precautions (5.1) ] . Prior to initiation of emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets, and during treatment with emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus [see Warnings and Precautions (5.5) ] .

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Emtricitabine, Rilpivirine, and Tenofovir side effects

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The most common side effects are mild.

Common side effects

  • Headache
  • Sleep disturbances (trouble sleeping)

When to get medical help

  • Call your doctor right away if you have a severe rash, or a rash with fever, blisters, mouth sores, red eyes, or facial swelling.
  • Seek medical help for severe depression, including thoughts of suicide or a suicide attempt.
  • Tell your doctor about bone pain that persists or worsens, pain in the arms or legs, fractures, or muscle pain or weakness. These can signal kidney problems.
  • Get help if you develop signs of lactic acidosis or serious liver problems. Treatment may need to be paused.
  • If you have hepatitis B and stop this medicine, watch for liver flare-ups and keep up follow-up testing.
  • Tell your doctor about new symptoms after starting treatment, since the recovering immune system can react to hidden infections.

Emtricitabine, Rilpivirine, and Tenofovir warnings and precautions

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  • Hepatitis B flare after stopping: this can be severe in people who have both HIV-1 and hepatitis B.
  • Skin and allergic reactions: severe reactions, including DRESS, have been reported. Stop and call your doctor.
  • Liver problems: higher risk if you have hepatitis B or C or abnormal liver tests.
  • Depression: severe depressive symptoms need prompt medical evaluation.
  • Kidney problems: include acute kidney failure and Fanconi syndrome.
  • Bone loss: bone density may decrease.
  • Heart rhythm: caution with drugs that prolong the QT interval.
  • Lactic acidosis: a build-up of acid in the blood, which can be serious.
  • Immune reconstitution syndrome: inflammation from hidden infections as the immune system recovers.

Emtricitabine, Rilpivirine, and Tenofovir interactions

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Several drugs can lower rilpivirine levels or affect your kidneys.

  • Carbamazepine, oxcarbazepine, phenobarbital, phenytoin: contraindicated, because they lower rilpivirine levels.
  • Rifampin and rifapentine: contraindicated. Rifabutin needs an extra rilpivirine tablet.
  • Proton pump inhibitors: contraindicated, since less rilpivirine is absorbed.
  • St John's wort and repeated dexamethasone: contraindicated.
  • H2 blockers: stagger the timing (12 hours before or 4 hours after).
  • Antacids: take 2 hours before or 4 hours after.
  • NSAIDs in high doses, and drugs cleared by the kidneys: may harm the kidneys or raise drug levels.
  • Other HIV medicines: not recommended.

Interactions listed in the FDA-approved label

From the Emtricitabine, Rilpivirine, and Tenofovir prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Other antiretroviral medications: The tablets are a complete regimen for HIV-1 infection, so coadministration with other antiretrovirals is not recommended. Coadministration not recommended
  • Antacids (e.g., aluminum, magnesium hydroxide, or calcium carbonate): Concomitant intake decreases RPV; no effect when taken at least 2 hours before or at least 4 hours after RPV. Administer antacids at least 2 hours before or at least 4 hours after the tablets.
  • Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin: Decrease RPV. Coadministration is contraindicated due to potential for loss of virologic response and development of resistance.
  • Antimycobacterials: rifampin, rifapentine, rifabutin: Decrease RPV. Rifampin and rifapentine: contraindicated. With rifabutin, take an additional 25 mg tablet of RPV (Edurant) once per day with the tablets and with a meal for the duration of rifabutin coadministration.
  • Azole antifungals: fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole: Increase RPV and decrease ketoconazole. No dose adjustment is required. Clinically monitor for breakthrough fungal infections.
  • Systemic glucocorticoid: dexamethasone (more than a single-dose treatment): Decreases RPV. Coadministration is contraindicated due to potential for loss of virologic response and development of resistance.
  • Hepatitis C antivirals: ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir: Increase tenofovir. Monitor for adverse reactions associated with TDF.
  • H2-receptor antagonists: cimetidine, famotidine, nizatidine, ranitidine: Famotidine taken 2 hours before RPV decreases RPV; no effect when taken 12 hours before or 4 hours after RPV. Administer H2-receptor antagonists at least 12 hours before or at least 4 hours after the tablets.
  • St John's wort (Hypericum perforatum): Decreases RPV. Coadministration is contraindicated due to potential for loss of virologic response and development of resistance.
  • Proton pump inhibitors (e.g., dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole): Decrease RPV. Coadministration is contraindicated due to potential for loss of virologic response and development of resistance.
Read the label’s full interactions text

7 DRUG INTERACTIONS • Emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets are a complete regimen for the treatment of HIV-1 infection; therefore, coadministration with other antiretroviral medications for treatment of HIV-1 infection is not recommended. ( 7.1 ) • Consult the Full Prescribing Information prior to and during treatment for important drug interactions. ( 4 , 5.7 , 7 ) 7.1 Not Recommended with Other Antiretroviral Medications Because emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets are a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended. Comprehensive information regarding potential drug-drug interactions with other antiretroviral medications is not provided. This section describes clinically relevant drug interactions with emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets. Drug interaction studies were conducted with the components of emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets (FTC, RPV, and TDF as single agents) or with emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets as a combination product [see Dosage and Administration (2) , Contraindications (4) , and Clinical Pharmacology (12.3) ]. 7.2 Drugs Inducing or Inhibiting CYP3A Enzymes Rilpivirine is primarily metabolized by cytochrome P450 (CYP) 3A, and drugs that induce or inhibit CYP3A may thus affect the clearance of RPV [see Contraindications (4) , Warnings and Precautions (5.7) , and Clinical Pharmacology (12.3) ]. Coadministration of RPV and drugs that induce CYP3A may result in decreased plasma concentrations of RPV and loss of virologic response and possible resistance to RPV or to the class of NNRTIs. Coadministration of RPV and drugs that inhibit CYP3A may result in increased plasma concentrations of RPV.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Check Emtricitabine, Rilpivirine, and Tenofovir against a supplement or herb →

Before taking Emtricitabine, Rilpivirine, and Tenofovir

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  • Test for hepatitis B before starting.
  • Tell your doctor about kidney or liver disease.
  • Not recommended with estimated creatinine clearance below 50 mL/min for Complera and the generic TDF tablets.
  • Tell your doctor about depression or bone problems.
  • If pregnant, viral load is monitored closely because rilpivirine levels are lower.
  • Breastfeeding carries risks, including passing HIV-1 to the baby.
  • Children need to weigh at least 35 kg for the TDF products.

Emtricitabine, Rilpivirine, and Tenofovir overdose

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If you take too much, you should be monitored for signs of toxicity. Treatment is supportive, including monitoring vital signs and an ECG (QT interval). There is no specific antidote for rilpivirine. Dialysis removes some emtricitabine and tenofovir but is unlikely to remove rilpivirine.

What Emtricitabine, Rilpivirine, and Tenofovir does in the body

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At the recommended dose, rilpivirine did not meaningfully change the QT interval (a heart rhythm measure). Higher doses of 3 and 12 times the recommended dose did lengthen it. This is why caution is advised with other QT-prolonging drugs.

How your body processes Emtricitabine, Rilpivirine, and Tenofovir

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The combination tablet gave drug exposures similar to taking the three medicines separately when taken with food. Taking it fasting raised rilpivirine exposure by about 25%. Food raised tenofovir and rilpivirine absorption. Rilpivirine is about 99% bound to plasma proteins. Emtricitabine and tenofovir are cleared mainly by the kidneys.

How to store Emtricitabine, Rilpivirine, and Tenofovir

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Store at 25 °C (77 °F), excursions permitted to 15 °C–30 °C (59 °F–86 °F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Emtricitabine, Rilpivirine, and Tenofovir: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Emtricitabine, Rilpivirine, and Tenofovir — the kind of thing our pharmacy team would talk through with you at the counter.

What is this medicine for?

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It treats HIV-1 infection as a complete regimen, so you usually don't need other HIV medicines with it. It's used either to start treatment or to replace a regimen that is already working well.

How should I take it?

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Take one tablet by mouth once a day with food. Taking it with a meal helps your body absorb it properly. Follow your prescriber's directions.

What side effects should I expect?

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The most common are headache and trouble sleeping. Call your doctor right away for a severe rash, severe low mood or thoughts of suicide, ongoing bone or muscle pain, or signs of liver or kidney problems.

Can I stop taking it suddenly?

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Please don't stop on your own. If you also have hepatitis B, stopping can cause a severe flare-up that may harm your liver. Talk with your doctor first, and they will monitor your liver for several months if you stop.

Can I take heartburn medicine with it?

▾
Proton pump inhibitors like omeprazole or pantoprazole must not be used with it. H2 blockers like famotidine are allowed if timed apart, either 12 hours before or 4 hours after. Antacids should be taken 2 hours before or 4 hours after. Check with me before starting any new product.

Is it safe in pregnancy?

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If you were already taking it and your virus is well controlled, your doctor may continue it. Rilpivirine levels are lower during pregnancy, so your viral load will be watched closely. Tell your doctor right away if you become pregnant.

Is Emtricitabine, Rilpivirine, and Tenofovir available over the counter?

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No. Emtricitabine, Rilpivirine, and Tenofovir is a prescription medicine: every Emtricitabine, Rilpivirine, and Tenofovir product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Emtricitabine, Rilpivirine, and Tenofovir first available?

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The earliest FDA record we hold for Emtricitabine, Rilpivirine, and Tenofovir is from 2011: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Emtricitabine, Rilpivirine, and Tenofovir was first used.

Who makes Emtricitabine, Rilpivirine, and Tenofovir?

▾
3 companies currently list Emtricitabine, Rilpivirine, and Tenofovir products in the FDA's NDC Directory, including Gilead Sciences, Inc., Laurus Labs Limited, Mylan Pharmaceuticals Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Emtricitabine, Rilpivirine, and Tenofovir on HelloPharmacist

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Detailed data & references for Emtricitabine, Rilpivirine, and Tenofovir Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Emtricitabine, Rilpivirine, and Tenofovir forms and strengths (how it comes)

Emtricitabine, Rilpivirine, and Tenofovir is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Emtricitabine, Rilpivirine, and Tenofovir inactive ingredients by manufacturer.

Tablet

By mouth
Brands Complera Odefsey
How this form is used
What it may be used for
  • Complera is a complete regimen for HIV-1 infection in adults and children weighing at least 35 kg.
  • Emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets are a complete regimen for HIV-1 infection, as initial therapy or to replace a stable regimen.
Important instructions
  • Complera: one tablet by mouth once daily with food.
  • Odefsey: one tablet by mouth once daily with a meal.
  • Complera: not recommended if estimated creatinine clearance is below 50 mL/min.
  • Complera: with rifabutin, an extra rilpivirine (Edurant) tablet is taken daily with a meal.
Available strengths 2 strengths
200 mg / 25 mg / 25 mg 200 mg / 25 mg / 300 mg
11 FDA-listed product records ⓘ

Emtricitabine, Rilpivirine, and Tenofovir on the U.S. market: products, makers and brands

How Emtricitabine, Rilpivirine, and Tenofovir appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

3 companies list 4 Emtricitabine, Rilpivirine, and Tenofovir product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2011. Brand names on the directory include Odefsey, Complera; the rest are generics.

1
Dose forms ⓘ
3
Labelers (makers, repackagers, distributors)
4
Brand names
4
FDA-listed product records ⓘ
2011
Earliest FDA record ⓘ
Gilead Sciences, Inc.50%
Laurus Labs Limited25%
Mylan Pharmaceuticals Inc.25%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Emtricitabine, Rilpivirine, and Tenofovir is used (Medicaid data)

A general measure of how commonly Emtricitabine, Rilpivirine, and Tenofovir is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Emtricitabine, Rilpivirine, and Tenofovir is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

48,910
Medicaid prescriptions filled (Q1–Q4 2025)
$206.6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Emtricitabine, Rilpivirine, and Tenofovir prescribed? Of the 1,601 medications we measure, Emtricitabine, Rilpivirine, and Tenofovir ranks #637 by Medicaid prescriptions — more than 60% of them.

Where Emtricitabine, Rilpivirine, and Tenofovir ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #637 of 1,601
#632 Eslicarbazepine 50,618 Rx #633 Pegfilgrastim Injectio... 50,322 Rx #634 Pyridostigmine 50,282 Rx #635 Capsaicin 49,268 Rx #636 Suvorexant 49,093 Rx #637 Emtricitabine, Rilpivi... 48,910 Rx #638 Eplerenone 48,763 Rx #639 Sumatriptan Nasal 48,078 Rx #640 Darbepoetin Alfa Injec... 47,924 Rx #641 Sofosbuvir and Velpata... 47,731 Rx #642 Asenapine 47,447 Rx

Utilization by Emtricitabine, Rilpivirine, and Tenofovir product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

emtricitabine 200 MG / rilpivirine 25 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet

3,058 Medicaid prescriptions (Q1–Q4 2025) 6% of Emtricitabine, Rilpivirine, and Tenofovir prescriptions shown $12.3M gross reimbursement (before rebates) ≈ $4,014 per prescription (gross)

Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1147334

Other Emtricitabine, Rilpivirine, and Tenofovir products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

45,852 Medicaid prescriptions (Q1–Q4 2025) 94% of Emtricitabine, Rilpivirine, and Tenofovir prescriptions shown $194.3M gross reimbursement (before rebates) ≈ $4,238 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Emtricitabine, Rilpivirine, and Tenofovir, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 10 listed Emtricitabine, Rilpivirine, and Tenofovir NDCs with Medicaid activity.

Compare Emtricitabine, Rilpivirine, and Tenofovir products

A representative set of FDA-listed product records for Emtricitabine, Rilpivirine, and Tenofovir — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Tablet
EMTRICITABINE 200 mg/1; RILPIVIRINE HYDROCHLORIDE 25 mg/1; TENOFOVIR ALAFENAMIDE FUMARATE 25 mg Oral Gilead Sciences, Inc. NDA View NDC →
EMTRICITABINE 200 mg/1; RILPIVIRINE HYDROCHLORIDE 25 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg Oral Gilead Sciences, Inc. NDA View NDC →
EMTRICITABINE 200 mg/1; RILPIVIRINE HYDROCHLORIDE 25 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg Oral Laurus Labs Limited ANDA View NDC →
EMTRICITABINE 200 mg/1; RILPIVIRINE HYDROCHLORIDE 25 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg Oral Mylan Pharmaceuticals Inc. ANDA View NDC →

Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Emtricitabine, Rilpivirine, and Tenofovir NDCs →

Emtricitabine, Rilpivirine, and Tenofovir recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Emtricitabine, Rilpivirine, and Tenofovir recalls since July 2021.

✅No Emtricitabine, Rilpivirine, and Tenofovir recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

💵 What Emtricitabine, Rilpivirine, and Tenofovir costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral EMTRICITABINE 200 mg/1; RILPIVIRINE HYDROCHLORIDE 25 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg $114.50 per tablet NDC details & price history
Tablet, Film Coated · Oral 200; 25; 300 mg/1; mg/1; mg $130.31 per tablet NDC details & price history
Tablet · Oral 200; 25; 25 mg/1; mg/1; mg $130.49 per tablet NDC details & price history
Tablet · Oral EMTRICITABINE 200 mg/1; RILPIVIRINE HYDROCHLORIDE 25 mg/1; TENOFOVIR ALAFENAMIDE FUMARATE 25 mg $130.49 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Emtricitabine, Rilpivirine, and Tenofovir brand names

Emtricitabine, Rilpivirine, and Tenofovir is sold under 2 brand names in the FDA directory — Odefsey, Complera. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Odefsey Complera

Who makes Emtricitabine, Rilpivirine, and Tenofovir: manufacturers and labelers

3 companies list Emtricitabine, Rilpivirine, and Tenofovir products with the FDA. By number of product records, the largest are Gilead Sciences, Inc., Laurus Labs Limited, Mylan Pharmaceuticals Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Gilead Sciences, Inc. 2 Laurus Labs Limited 1 Mylan Pharmaceuticals Inc. 1

Emtricitabine, Rilpivirine, and Tenofovir drug class (RxNorm)

Emtricitabine, Rilpivirine, and Tenofovir belongs to the Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor class.

Pharmacologic class Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Drug family (ATC) Non-nucleoside reverse transcriptase inhibitors
How it works Non-Nucleoside Reverse Transcriptase Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Emtricitabine, Rilpivirine, and Tenofovir page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 16, 2025
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Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Emtricitabine, Rilpivirine, and Tenofovir.
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Emtricitabine, Rilpivirine, and Tenofovir after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
4
Finished products in the current FDA directory
4
Companies listing them (makers, repackagers, distributors)
3
FDA labeler codes behind them ⓘ
3
Linked representative label ⓘ
Gilead Sciences, Inc.
Linked label effective
Jul 16, 2025
Composite sections available
23
Linked SPL Set ID
d637cfab-f1e8-4eb3-a1b3-f85ca3bec612
Linked SPL Document ID
21d7850d-11ea-43cc-84a5-0dae02a19ce6
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Gilead Sciences, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →