FDA-filed SPL labeling · retrieved through openFDA

Buprenorphine / Naloxone

Buprenorphine/naloxone is a combination medication used for the maintenance treatment of opioid dependence as part of a complete treatment plan.

Brand names ZubsolvSuboxoneBuprenorphine and Naloxone Sublingual Film
Drug classes ⓘ Opioid Antagonists
Rx Schedule CIII Forms 2 Routes Sublingual · Buccal; Sublingual · Buccal, Sublingual
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 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 55 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 →

At a glance
Linked label effectiveDec 27, 2025
Clinical labels in scope ⓘ55
AvailabilityRx
Earliest approval/marketing year ⓘ2010
FDA-listed product records ⓘ235
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 22, 2026
⭐ Buprenorphine / Naloxone at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Buprenorphine/naloxone is an effective, well-established medication for maintenance treatment of opioid dependence, used alongside counseling as part of a full recovery plan. The biggest safety concern is combining it with benzodiazepines, alcohol, or other sedatives, which can cause fatal breathing problems — always tell every provider what you're taking. Work closely with your prescriber to find the right dose and never stop this medication suddenly.
How we write & review this content — our editorial policy →

📖 Buprenorphine / Naloxone: Patient Information Guide

A plain-language walkthrough of Buprenorphine / Naloxone — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Buprenorphine/naloxone products are used for the maintenance treatment of opioid dependence, always as part of a plan that includes counseling and psychosocial support.

  • Buprenorphine and naloxone sublingual tablets (including generic formulations and Suboxone tablets) are indicated for the maintenance treatment of opioid dependence
  • Suboxone sublingual film is indicated for the treatment of opioid dependence
  • Zubsolv sublingual tablets are indicated for the treatment of opioid dependence, used following induction
⚙️How it works▾

Buprenorphine partially activates mu-opioid receptors in the brain — the same receptors targeted by opioids like heroin and morphine — but with a ceiling effect, meaning its opioid effects plateau rather than keep climbing with higher doses. This partial activation is enough to reduce cravings and prevent withdrawal symptoms, while producing fewer dangerous effects than full opioids. Buprenorphine also blocks kappa-opioid receptors. Naloxone, the second ingredient, is a strong opioid blocker added specifically to deter misuse: when taken as directed under the tongue or cheek, it is largely inactive; if injected, it triggers immediate, intense withdrawal in someone physically dependent on opioids.

💊How it's taken▾

Buprenorphine/naloxone is taken once daily, dissolved under the tongue (or against the cheek for the film form). Treatment is started only after clear signs of opioid withdrawal appear — starting too soon can trigger sudden, intense withdrawal. During the very first days, doses may be split and given in smaller amounts; once stable, a single daily dose is used.

  • Sublingual tablets are placed under the tongue until fully dissolved
  • Suboxone film can be placed under the tongue or against the inside of the cheek
  • Never chew or swallow the tablet or film
  • Your prescriber will adjust your dose over time — do not change your dose on your own
🤒Side effects — in detail▾

The most commonly reported side effects include:

  • Headache
  • Nausea and vomiting
  • Constipation
  • Sweating
  • Insomnia (trouble sleeping)
  • General pain or abdominal discomfort
  • Mouth numbness, tongue soreness, or redness in the mouth (from dissolving under the tongue)
  • Swelling in the legs or feet (peripheral edema)

Seek medical attention right away for serious reactions: severely slowed or stopped breathing, extreme drowsiness you can't shake, signs of liver problems (yellowing skin or eyes, dark urine), or any allergic reaction such as hives, swelling, or difficulty breathing.

⚠️Warnings & precautions▾
  • Breathing emergency: Buprenorphine can cause life-threatening, slow or stopped breathing — especially when mixed with benzodiazepines, alcohol, sedatives, or other opioids. Deaths have been reported. Always have an opioid overdose reversal agent (such as naloxone) on hand.
  • Children: Even a small accidental exposure can cause fatal breathing problems in children. Keep this medication locked away and out of sight.
  • Liver damage: Cases of serious liver injury, including liver failure, have been reported. Your doctor should check your liver function before and during treatment.
  • Withdrawal if stopped suddenly: Do not stop this medication abruptly. Tapering slowly under medical supervision is required to avoid withdrawal symptoms.
  • Neonatal opioid withdrawal syndrome (NOWS): Babies born to mothers on this medication may experience withdrawal symptoms after birth. This is an expected and treatable outcome, but the prescriber must be informed if you are or become pregnant.
  • Adrenal insufficiency: Long-term opioid use can reduce the adrenal glands' ability to make stress hormones. Symptoms include fatigue, weakness, nausea, and low blood pressure.
  • Abuse potential: Buprenorphine is a controlled substance and can be misused. It should be stored securely and taken only as prescribed.
🔀What it interacts with▾

Several medications and substances interact meaningfully with buprenorphine/naloxone:

  • Benzodiazepines and sedatives (e.g., diazepam, alprazolam, zolpidem) — dramatically increase the risk of dangerous sedation, coma, and fatal breathing problems
  • Alcohol — adds to sedation and breathing risks; should be avoided
  • Other opioids — increase overdose risk; can also trigger sudden withdrawal if taken before this medication has worn off
  • CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir, atazanavir) — raise buprenorphine blood levels, increasing sedation and breathing risks
  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) — lower buprenorphine levels, potentially causing withdrawal or reduced effectiveness
  • Serotonergic drugs (SSRIs, SNRIs, tricyclic antidepressants, triptans, tramadol, linezolid) — risk of serotonin syndrome, a potentially life-threatening reaction
  • MAO inhibitors — do not use together or within 14 days of stopping an MAOI; serious toxicity risk
  • Muscle relaxants (e.g., cyclobenzaprine) — increased respiratory depression risk
  • Anticholinergic drugs — may worsen constipation or cause urinary retention
  • Diuretics (water pills) — buprenorphine may reduce their effectiveness

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Allergy: Do not take if you have ever had a serious allergic reaction (anaphylaxis, hives, throat swelling) to buprenorphine or naloxone — this is a contraindication
  • Liver disease: Use with caution if you have hepatitis B or C, or any liver condition; severe liver impairment makes this medication inappropriate, and moderate impairment requires careful evaluation
  • Pregnancy: Discuss risks and benefits with your doctor; neonatal opioid withdrawal syndrome can occur in newborns, but untreated opioid dependence also carries serious pregnancy risks
  • Breastfeeding: Buprenorphine passes into breast milk; discuss with your doctor before breastfeeding
  • Older adults: Monitor closely for sedation and breathing problems
  • Breathing problems: Use with caution if you have COPD, sleep apnea, or other lung conditions
  • All current medications: Tell your prescriber about everything you take — including benzodiazepines, sleep aids, antidepressants, antifungals, and HIV medications
🚑If you take too much▾

Signs of buprenorphine overdose include pinpoint (very small) pupils, extreme sleepiness or unresponsiveness, low blood pressure, low blood sugar, and dangerously slow or stopped breathing. In an overdose emergency, call 911 immediately and monitor breathing. An opioid overdose reversal agent may be used, but higher-than-usual doses and repeated administration may be needed because buprenorphine stays in the body for a long time and has a strong grip on opioid receptors. Medical observation should continue for an extended period.

📡Pharmacodynamics — effects in the body▾

Buprenorphine produces typical opioid effects — such as pain relief and euphoria — but these effects have a ceiling: after a certain dose, increasing the amount does not increase the effect further, unlike full opioids. When taken under the tongue, naloxone has little to no noticeable effect on its own; however, it blocks opioid receptors if injected, triggering withdrawal in people who are opioid-dependent. Buprenorphine's effects at relevant clinical doses do not cause significant changes in blood pressure, heart rate, or oxygen levels compared to placebo, though it can affect breathing at higher doses and can suppress the body's normal respiratory drive, particularly when combined with other depressants.

🔬Pharmacokinetics — how your body processes it▾

When dissolved under the tongue or against the cheek, buprenorphine is absorbed into the bloodstream through the mouth's mucous membranes. Buprenorphine stays in the body for a long time — its elimination half-life (the time for blood levels to drop by half) ranges from 24 to 42 hours, which is why once-daily dosing is effective. Naloxone clears much more quickly, with a half-life of 2 to 12 hours when absorbed sublingually. Buprenorphine is primarily broken down by the liver enzyme CYP3A4 and is eliminated mainly in the feces (about 69%) and urine (about 30%). The sublingual film tends to deliver somewhat higher drug levels than the sublingual tablet at the same doses — the two forms are not interchangeable on a milligram-for-milligram basis.

📦How to store it▾

Store at 20° to 25°C (68° to 77°F). Store buprenorphine and naloxone sublingual film securely and dispose of properly .

📄 Written from Buprenorphine / Naloxone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

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

What exactly does this medication do — is it just replacing one opioid with another? ▾
That's a really common question, and it's a fair one. Buprenorphine is technically a partial opioid — it does activate the same receptors in your brain that opioids like heroin or oxycodone target, but only partially. Think of it like a key that fits the lock but only turns it halfway. That's enough to stop cravings and prevent withdrawal without producing the intense high of a full opioid. The naloxone in the combination is there specifically to discourage misuse — if someone were to inject it instead of taking it under the tongue, the naloxone would trigger immediate withdrawal. Used as prescribed, this medication is a proven medical treatment for opioid dependence, not just a substitute.
How do I take it — do I just swallow the tablet or film? ▾
Don't swallow it — the tablet or film needs to dissolve under your tongue (or, for the film, it can also go against the inside of your cheek). Hold it there until it fully dissolves. Swallowing it would mean very little of the medication gets absorbed, since the stomach and liver break most of it down before it can reach your bloodstream. Take it once daily, as a single dose. Your prescriber will give you specific instructions based on which product you're using.
Why did my doctor say I need to wait until I'm in withdrawal before starting this? ▾
This is really important. If you take buprenorphine/naloxone while other opioids are still active in your system, it can knock those opioids off the receptors and trigger sudden, intense withdrawal — which is very uncomfortable and happens fast. Waiting until you're already showing clear signs of withdrawal means those other opioids have mostly cleared, so the medication can step in without causing that reaction. Your prescriber will guide you on exactly when to take your first dose. Don't skip this step.
What should I absolutely avoid while taking this medication? ▾
The biggest one is benzodiazepines — medications like Valium, Xanax, Ativan, or Klonopin. Combining them with buprenorphine/naloxone can cause dangerously slow breathing and has been linked to deaths. Alcohol and other sedatives carry the same risk. Also tell every doctor, dentist, or pharmacist you see that you're on this medication — some antibiotics, antifungals, and HIV medications can affect how much buprenorphine is in your bloodstream. Don't start or stop any medication without checking first.
I'm pregnant — is it safe to keep taking this? ▾
Talk to your doctor right away, but don't stop the medication on your own. Untreated opioid dependence during pregnancy carries real risks — including preterm birth and fetal death — and those risks are often greater than the risks of staying on treatment. Babies born to mothers on buprenorphine can experience neonatal opioid withdrawal syndrome (NOWS), which means they may have withdrawal symptoms after birth. This is a known, treatable outcome and your medical team will be prepared for it. Your dose may also need adjusting during pregnancy, so regular check-ins with your prescriber are important.
Can I just stop taking it when I feel ready? ▾
Please don't stop suddenly without talking to your prescriber first. Your body adapts to this medication over time, and stopping abruptly can trigger opioid withdrawal symptoms. When the time is right to taper off, your doctor will help you do it gradually to minimize discomfort. In the meantime, keep this medication stored safely — it should be locked away from children, since even a small amount can cause a fatal breathing emergency in a child.
Is Buprenorphine / Naloxone available over the counter? ▾
Buprenorphine / Naloxone is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
Is Buprenorphine / Naloxone a controlled substance? ▾
Yes — Buprenorphine / Naloxone is a federally controlled substance (Schedule III) in the United States, so how it is prescribed, refilled and dispensed is regulated by the DEA.
When was Buprenorphine / Naloxone first available? ▾
Buprenorphine / Naloxone has been available in the United States since at least 2010, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Buprenorphine / Naloxone? ▾
Buprenorphine / Naloxone is supplied by 35 manufacturers listed in the FDA NDC Directory, including Bryant Ranch Prepack, Orexo US, Inc., Remedyrepack Inc..

💬 Answers drafted from Buprenorphine / Naloxone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

🌿Drug & Supplement CheckerBuprenorphine / Naloxone vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Buprenorphine / Naloxone NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Buprenorphine / Naloxone comes

Buprenorphine / Naloxone is available in 2 forms. 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.

Sublingual tablet

Under the tongue
Brands Zubsolv
How this form is used
What it may be used for
  • Buprenorphine and naloxone sublingual tablets are indicated for the maintenance treatment of opioid dependence
  • Zubsolv is indicated for the treatment of opioid dependence, following induction
  • All sublingual tablet formulations are used as part of a complete treatment plan that includes counseling and psychosocial support
Important instructions
  • Buprenorphine and naloxone sublingual tablets are placed under the tongue and taken as a single daily dose
  • Zubsolv sublingual tablets are administered sublingually as a single daily dose following induction
  • Induction (starting treatment) should only begin when clear signs of opioid withdrawal are present, to avoid triggering sudden withdrawal
  • Doses are gradually adjusted after induction to suppress withdrawal symptoms and support treatment
Available strengths 9 strengths
0.5 mg / 2 mg 0.7 mg / 0.18 mg 1.4 mg / 0.36 mg 2 mg / 0.5 mg 2.9 mg / 0.71 mg 5.7 mg / 1.4 mg
Show 3 more strengths Show fewer strengths
8 mg / 2 mg 8.6 mg / 2.1 mg 11.4 mg / 2.9 mg
164 FDA-listed product records ⓘ

Sublingual film

Inside the cheek · Under the tongue
Brands Suboxone
How this form is used
What it may be used for
  • Suboxone sublingual film is indicated for the treatment of opioid dependence
  • Suboxone sublingual film is used as part of a complete treatment plan that includes counseling and psychosocial support
Important instructions
  • Suboxone sublingual film is administered as a single daily dose, placed under the tongue or against the inside of the cheek
  • Suboxone sublingual film should only be started when clear signs of opioid withdrawal are present, to avoid triggering sudden withdrawal
  • During the first days of treatment, Suboxone sublingual film doses are given in divided amounts; once stabilized, it is taken as a single daily dose
  • Do not eat or drink until the film has fully dissolved
Available strengths 4 strengths
2 mg / 0.5 mg 4 mg / 1 mg 8 mg / 2 mg 12 mg / 3 mg
71 FDA-listed product records ⓘ

📊 Buprenorphine / Naloxone across the U.S. market

How Buprenorphine / Naloxone 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.

2
Dose forms ⓘ
35
Manufacturers
6
Brand names
235
FDA-listed product records ⓘ
2010
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Bryant Ranch Prepack11%
Orexo US, Inc.8%
Remedyrepack Inc.7%
Mylan Pharmaceuticals Inc.5%
Indivior Inc.5%
Dr.Reddys Laboratories Inc5%
Other makers58%

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

📈 How widely Buprenorphine / Naloxone is used

A general measure of how commonly Buprenorphine / Naloxone 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 Buprenorphine / Naloxone 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.

6,982,290
Medicaid prescriptions filled (Q1–Q4 2025)
$1.17B gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Buprenorphine / Naloxone prescribed? Of the 1,596 medications we measure, Buprenorphine / Naloxone ranks #21 by Medicaid prescriptions — more than 99% of them.

Where Buprenorphine / Naloxone ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #21 of 1,596
#16 Amlodipine 8,001,920 Rx #17 Ergocalciferol 7,906,448 Rx #18 Trazodone 7,898,849 Rx #19 Levothyroxine 7,786,593 Rx #20 Acetaminophen 7,225,940 Rx #21 Buprenorphine / Naloxo... 6,982,290 Rx #22 Lisinopril 6,788,371 Rx #23 Famotidine 6,721,162 Rx #24 Bupropion 6,669,702 Rx #25 Fluoxetine 6,471,546 Rx #26 Escitalopram 6,377,287 Rx

Utilization by Buprenorphine / Naloxone 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.

The 8 mg / 2 mg sublingual film is the most-dispensed Buprenorphine / Naloxone product — about 52% of these Medicaid prescriptions.

buprenorphine 8 MG / naloxone 2 MG Sublingual Film Most dispensed

3,642,176 Medicaid prescriptions (Q1–Q4 2025) 52% of Buprenorphine / Naloxone prescriptions shown $827.3M gross reimbursement (before rebates) ≈ $227 per prescription (gross)

Summed across the 5 of 22 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1010604

buprenorphine 8 MG / naloxone 2 MG Sublingual Tablet

2,081,526 Medicaid prescriptions (Q1–Q4 2025) 30% of Buprenorphine / Naloxone prescriptions shown $96.8M gross reimbursement (before rebates) ≈ $46 per prescription (gross)

Summed across the 12 of 89 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 351267

buprenorphine 2 MG / naloxone 0.5 MG Sublingual Tablet

351,481 Medicaid prescriptions (Q1–Q4 2025) 5% of Buprenorphine / Naloxone prescriptions shown $11.8M gross reimbursement (before rebates) ≈ $34 per prescription (gross)

Summed across the 11 of 39 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 351266

buprenorphine 12 MG / naloxone 3 MG Sublingual Film

329,299 Medicaid prescriptions (Q1–Q4 2025) 5% of Buprenorphine / Naloxone prescriptions shown $123.5M gross reimbursement (before rebates) ≈ $375 per prescription (gross)

Summed across the 5 of 20 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1307061

buprenorphine 4 MG / naloxone 1 MG Sublingual Film

239,955 Medicaid prescriptions (Q1–Q4 2025) 3% of Buprenorphine / Naloxone prescriptions shown $45.4M gross reimbursement (before rebates) ≈ $189 per prescription (gross)

Summed across the 5 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1307056

buprenorphine 2 MG / naloxone 0.5 MG Sublingual Film

222,662 Medicaid prescriptions (Q1–Q4 2025) 3% of Buprenorphine / Naloxone prescriptions shown $22.5M gross reimbursement (before rebates) ≈ $101 per prescription (gross)

Summed across the 5 of 22 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1010600

buprenorphine 5.7 MG / naloxone 1.4 MG Sublingual Tablet

63,391 Medicaid prescriptions (Q1–Q4 2025) <1% of Buprenorphine / Naloxone prescriptions shown $24M gross reimbursement (before rebates) ≈ $378 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1431102

buprenorphine 8.6 MG / naloxone 2.1 MG Sublingual Tablet

24,268 Medicaid prescriptions (Q1–Q4 2025) <1% of Buprenorphine / Naloxone prescriptions shown $13.1M gross reimbursement (before rebates) ≈ $540 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1597573

buprenorphine 2.9 MG / naloxone 0.71 MG Sublingual Tablet

10,711 Medicaid prescriptions (Q1–Q4 2025) <1% of Buprenorphine / Naloxone prescriptions shown $3.3M gross reimbursement (before rebates) ≈ $310 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1666338

buprenorphine 11.4 MG / naloxone 2.9 MG Sublingual Tablet

8,884 Medicaid prescriptions (Q1–Q4 2025) <1% of Buprenorphine / Naloxone prescriptions shown $4.9M gross reimbursement (before rebates) ≈ $556 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1597568

buprenorphine 1.4 MG / naloxone 0.36 MG Sublingual Tablet

5,312 Medicaid prescriptions (Q1–Q4 2025) <1% of Buprenorphine / Naloxone prescriptions shown $818,484 gross reimbursement (before rebates) ≈ $154 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1431076

buprenorphine 0.7 MG / naloxone 0.18 MG Sublingual Tablet

2,625 Medicaid prescriptions (Q1–Q4 2025) <1% of Buprenorphine / Naloxone prescriptions shown $427,536 gross reimbursement (before rebates) ≈ $163 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1864412

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 Buprenorphine / Naloxone, 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 49 of 222 listed Buprenorphine / Naloxone NDCs with Medicaid activity.

🔍 Compare Buprenorphine / Naloxone products

A representative set of FDA-listed product records for Buprenorphine / Naloxone — 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.)

Showing 200 of 235 products — FDA National Drug Code Directory. See every product, package size and price: browse all 235 Buprenorphine / Naloxone NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.

Multiple ingredients (MIN) Buprenorphine / Naloxone RxCUI 352364 3 dose forms · 15 strengths
  1. Dose form (SCDF) Buccal Film RxCUI 1542389 No current FDA listing
    Clinical drug / strength (SCD) buprenorphine 2.1 MG / naloxone 0.3 MG RxCUI 1542390 buprenorphine 4.2 MG / naloxone 0.7 MG RxCUI 1544851 buprenorphine 6.3 MG / naloxone 1 MG RxCUI 1544854
  3. Dose form (SCDF) Sublingual Tablet RxCUI 378762 In current FDA listings
    Clinical drug / strength (SCD) buprenorphine 0.7 MG / naloxone 0.18 MG RxCUI 1864412 buprenorphine 1.4 MG / naloxone 0.36 MG RxCUI 1431076 buprenorphine 11.4 MG / naloxone 2.9 MG RxCUI 1597568 buprenorphine 2 MG / naloxone 0.5 MG RxCUI 351266 buprenorphine 2.9 MG / naloxone 0.71 MG RxCUI 1666338 buprenorphine 5.7 MG / naloxone 1.4 MG RxCUI 1431102 buprenorphine 8 MG / naloxone 2 MG RxCUI 351267 buprenorphine 8.6 MG / naloxone 2.1 MG RxCUI 1597573

Look up RxCUI 352364 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Zubsolv Suboxone Buprenorphine and Naloxone Sublingual Film

🏭 Manufacturers & labelers

Bryant Ranch Prepack 27 Orexo US, Inc. 18 Remedyrepack Inc. 17 Mylan Pharmaceuticals Inc. 12 Indivior Inc. 12 Dr.Reddys Laboratories Inc 12 Alvogen Inc. 12 Hikma Pharmaceuticals USA Inc. 8 Redpharm Drug 7 Actavis Pharma, Inc. 6 Camber Pharmaceuticals, Inc. 6 Edenbridge Pharmaceuticals LLC. 6 Ingenus Pharmaceuticals, Llc 6 Amneal Pharmaceuticals LLC 6 Sun Pharmaceutical Industries, Inc. 6 Lannett Company, Inc. 6 American Health Packaging 6 SpecGx LLC 6 AvPAK 6 Clinical Solutions Wholesale, LLC 5 Golden State Medical Supply, Inc. 4 Ascend Laboratories, LLC 4 Aveva Drug Delivery Systems Inc. 4 Major Pharmaceuticals 4

…and 11 more on the FDA NDC directory.

RxNorm drug class

Buprenorphine / Naloxone belongs to the Partial Opioid Agonist class.

Pharmacologic class Partial Opioid Agonist
Drug family (ATC) Oripavine derivatives, Drugs used in opioid dependence
How it works Partial Opioid Agonists

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.

🔬 Where this comes from

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 Dec 27, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Buprenorphine / Naloxone.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Buprenorphine / Naloxone after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
55
NDC products indexed
235
Distinct labelers/manufacturers represented
35
Linked representative label ⓘ
Orexo US, Inc.
Linked label effective
Dec 27, 2025
Composite sections available
24
Linked SPL Set ID
5f5cfcfe-d52b-49e6-8fe4-550477332dd2
Linked SPL Document ID
8c67e97f-118f-4226-972a-a9031ef6f5ce
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 55 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Orexo US, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.