Prescription medicine
Buprenorphine and naloxone Brand names: Zubsolv, Suboxone
Buprenorphine and naloxone (Suboxone) is a prescription medicine with an FDA approval on record since 2002. FDA's NDC Directory lists it from 26 generic labelers, and pharmacies paid $0.521 per buprenorphine-naloxone 2-0.5 mg sl tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $5.26 per tablet (Zubsolv 0.7-0.18 mg tablet sl).
- Generic listed
- DEA Schedule III
Check it at the source: the buprenorphine and naloxone FDA label on DailyMed (effective July 26, 2026, Hikma Pharmaceuticals USA Inc.); the NDA 20733 record on Drugs@FDA; every buprenorphine and naloxone label on DailyMed.
Highlights of the record
FDA label of July 26, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageBuprenorphine and Naloxone Sublingual Tablets are indicated for the maintenance treatment of opioid dependence.
Forms and 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
- 4 mg / 1 mg
- 5.7 mg / 1.4 mg
- 8 mg / 2 mg
- 8.6 mg / 2.1 mg
- 11.4 mg / 2.9 mg
- 12 mg / 3 mg
Tablet; film; orally disintegrating tablet; soluble film.
On the market
- Earliest approval on file
- October 8, 2002 Suboxone, Indivior; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 20 first February 22, 2013; 18 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 29 of which 26 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- March 26, 2030 Suboxone film; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.521 per tablet Buprenorphine-naloxone 2-0.5 mg sl tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2021 0 Class I among all firms' recalls; latest October 18, 2022
- FAERS reports
- 26,265 through July 30, 2026
What is buprenorphine and naloxone used for?
From the label: indications and usageBuprenorphine and Naloxone Sublingual Tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and Naloxone Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. Buprenorphine and Naloxone Sublingual Tablets contain buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and are indicated for the maintenance treatment of opioid dependence. ( 1 ) Buprenorphine and Naloxone Sublingual Tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support.
Conditions named in the indications of buprenorphine and naloxone's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Opioid Antagonist and Partial Opioid Agonist.
Source: FDA drug label (buprenorphine and naloxone), Hikma Pharmaceuticals USA Inc., effective July 26, 2026 (SPL set 713db2c6-0544-4633-b874-cfbeaf93db89), via openFDA; the full label on DailyMed
What does the patient leaflet for buprenorphine and naloxone say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Buprenorphine and Naloxone Sublingual Tablets?Buprenorphine and Naloxone Sublingual Tablets contain a medicine called buprenorphine. Buprenorphine is an opioid that can cause serious and life-threatening problems, especially if you take or use certain other medicines or drugs. • Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse opioid overdose including accidental use of Buprenorphine and Naloxone Sublingual Tablets by a child. If naloxone or nalmefene is given, you must call 911 or get emergency medical help right away to treat an overdose or accidental use of an opioid. • Buprenorphine and Naloxone Sublingual Tablets may cause serious and life-threatening breathing problems. Get emergency help right away if you: o feel faint o have blurred vision o feel dizzy o have slurred speech o are confused o are breathing slower than normal o feel sleepy or uncoordinated o cannot think well or clearly • Do not take Buprenorphine and Naloxone Sublingual Tablets with certain medicines. Taking Buprenorphine and Naloxone Sublingual Tablets with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. • Do not inject (“shoot-up”) Buprenorphine and Naloxone Sublingual Tablets. Injecting Buprenorphine and Naloxone Sublingual Tablets may cause life-threatening infections and other serious health problems. Injecting Buprenorphine and Naloxone Sublingual Tablets may cause sudden serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings. […]
From the patient leaflet: What should I avoid while taking Buprenorphine and Naloxone Sublingual Tablets?Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how Buprenorphine and Naloxone Sublingual Tablets affect you. Buprenorphine can cause drowsiness and slow reaction times. Buprenorphine and Naloxone Sublingual Tablets can make you sleepy, dizzy, or lightheaded. • You should not drink alcohol or take prescription or over-the-counter medicines that contain alcohol while taking Buprenorphine and Naloxone Sublingual Tablets, because this can lead to loss of consciousness or even death.
Source: FDA drug label (buprenorphine and naloxone), Hikma Pharmaceuticals USA Inc., effective July 26, 2026 (SPL set 713db2c6-0544-4633-b874-cfbeaf93db89), via openFDA; the full label on DailyMed
Is there a generic for buprenorphine and naloxone (Suboxone)?
The FDA approved the first generic buprenorphine and naloxone on February 22, 2013. 20 generic applications are approved; 18 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists buprenorphine and naloxone from 26 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 3 patents for Suboxone film, the last expiring on March 26, 2030; a patent listed only for Bunavail film runs to April 24, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2002 earliest approval on file
- 2013 first generic approved
- 2030 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for buprenorphine and naloxone (Suboxone)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.521 per Buprenorphine-naloxone 2-0.5 mg sl tablet, about the same as a year earlier. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Buprenorphine-naloxone 2-0.5 mg sl tablet (generic)
- Zubsolv 0.7-0.18 mg tablet sl (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Buprenorphine-naloxone 12-3 mg sl film | Generic | $4.49 per film | n/a | +4% |
| Buprenorphine-naloxone 2-0.5 mg sl film | Generic | $1.39 per film | n/a | -27% |
| Buprenorphine-naloxone 2-0.5 mg sl tablet | Generic | $0.521 per tablet | $15.64 | -0.2% |
| Buprenorphine-naloxone 4-1 mg sl film | Generic | $2.58 per film | n/a | -26% |
| Buprenorphine-naloxone 8-2 mg sl film | Generic | $1.98 per film | n/a | +2% |
| Buprenorphine-naloxone 8-2 mg sl tablet | Generic | $0.663 per tablet | $19.88 | -6% |
| Suboxone 12 mg-3 mg sl film | Brand | $17.16 per film many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -0.2% |
| Suboxone 2 mg-0.5 mg sl film | Brand | $4.79 per film | n/a | -0.1% |
| Suboxone 4 mg-1 mg sl film | Brand | $8.58 per film | n/a | no change |
| Suboxone 8 mg-2 mg sl film | Brand | $8.59 per film | n/a | no change |
| Zubsolv 0.7-0.18 mg tablet sl | Brand | $5.26 per tablet | $157.84 | +4% |
| Zubsolv 1.4-0.36 mg tablet sl | Brand | $5.26 per tablet | $157.94 | +4% |
| Zubsolv 11.4-2.9 mg tablet sl | Brand | $21.05 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $631.44 | +4% |
| Zubsolv 2.9-0.71 mg tablet sl | Brand | $10.52 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $315.56 | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has buprenorphine and naloxone been recalled?
The FDA's Enforcement Report lists 2 recalls naming buprenorphine and naloxone since 2021: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 18, 2022 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Presence of Foreign Substance |
| February 26, 2021 | Class II | Alvogen, Inc | Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low) |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the buprenorphine and naloxone label say about other medicines?
The buprenorphine and naloxone label names 26 other medicines in its interaction, contraindication or warning sections. The labels of 12 other medicines name buprenorphine and naloxone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atazanavir | drug interactions | Antiretrovirals: Protease inhibitors (PIs) Clinical Impact: Studies have shown some antiretroviral protease inhibitors (PIs) with CYP3A4 inhibitory activity (…) have little effect on buprenorphine pharmacokinetic and no significant pharmacodynamic effects. … Intervention: Monitor patients taking Buprenorphine and Naloxone Sublingual Tablets and atazanavir with and without ritonavir, and reduce dose of Buprenorphine and Naloxone Sublingual Tablets if warranted. … |
| Carbamazepine | drug interactions | CYP3A4 Inducers Clinical Impact: The concomitant use of buprenorphine and CYP3A4 inducers can decrease the plasma concentration of buprenorphine, potentially resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence … reduction and monitor for signs of respiratory depression. Examples: Rifampin, carbamazepine, phenytoin. |
| Cyclobenzaprine | drug interactions | Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as … |
| Efavirenz | drug interactions | Antiretrovirals: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) Clinical Impact: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are metabolized principally by CYP3A4. Efavirenz, nevirapine, and etravirine are known CYP3A inducers, whereas delavirdine is a CYP3A inhibitor. … dose monitored if NNRTIs are added to their treatment regimen. Examples: efavirenz, nevirapine, etravirine, delavirdine. |
| Erythromycin | drug interactions | Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir). |
| Etravirine | drug interactions | Antiretrovirals: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) Clinical Impact: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are metabolized principally by CYP3A4. Efavirenz, nevirapine, and etravirine are known CYP3A inducers, whereas delavirdine is a CYP3A inhibitor. … NNRTIs are added to their treatment regimen. Examples: efavirenz, nevirapine, etravirine, delavirdine. |
| Gabapentin | drug interactions | Benzodiazepines or Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effects, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, increases the risk of respiratory depression, profound sedation, coma, and death. … anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. |
| Ketoconazole | drug interactions | Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir). |
| Linezolid | drug interactions | Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Lopinavir and ritonavir | drug interactions | Antiretrovirals: Protease inhibitors (PIs) Clinical Impact: Studies have shown some antiretroviral protease inhibitors (PIs) with CYP3A4 inhibitory activity (…) have little effect on buprenorphine pharmacokinetic and no significant pharmacodynamic effects. … Intervention: Monitor patients taking Buprenorphine and Naloxone Sublingual Tablets and atazanavir with and without ritonavir, and reduce dose of Buprenorphine and Naloxone Sublingual Tablets if warranted. … |
| Metaxalone | drug interactions | Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and … |
| Methadone | warnings and precautions | Signs and Symptoms Because it contains naloxone, Buprenorphine and Naloxone Sublingual Tablets are highly likely to produce marked and intense withdrawal signs and symptoms if misused parenterally by individuals dependent on full opioid agonists such as heroin, morphine, or methadone. |
| Methylene blue | drug interactions | Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Mirtazapine | drug interactions | Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those … |
Every other medicine the buprenorphine and naloxone label names
| Medicine named | Section | What the label says |
|---|---|---|
| Morphine | warnings and precautions | … parenterally by individuals dependent on full opioid agonists such as heroin, morphine, or methadone. |
| Nalmefene | warnings and precautions | Advise patients and caregivers that an opioid overdose reversal agent, such as naloxone or nalmefene, may also be administered for a known or suspected overdose with buprenorphine itself. |
| Nelfinavir | drug interactions | Antiretrovirals: Protease inhibitors (PIs) Clinical Impact: Studies have shown some antiretroviral protease inhibitors (PIs) with CYP3A4 inhibitory activity (…) have little effect on buprenorphine pharmacokinetic and no significant pharmacodynamic effects. … Intervention: Monitor patients taking Buprenorphine and Naloxone Sublingual Tablets and atazanavir with and without ritonavir, and reduce dose of Buprenorphine and Naloxone Sublingual Tablets if warranted. … |
| Nevirapine | drug interactions | Antiretrovirals: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) Clinical Impact: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are metabolized principally by CYP3A4. Efavirenz, nevirapine, and etravirine are known CYP3A inducers, whereas delavirdine is a CYP3A inhibitor. … monitored if NNRTIs are added to their treatment regimen. Examples: efavirenz, nevirapine, etravirine, delavirdine. |
| Phenelzine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). Intervention: The use of Buprenorphine and Naloxone Sublingual Tablets is not recommended for patients taking MAOIs or within 14 days of stopping such treatment. Examples: phenelzine, tranylcypromine, linezolid. |
| Phenytoin | drug interactions | CYP3A4 Inducers Clinical Impact: The concomitant use of buprenorphine and CYP3A4 inducers can decrease the plasma concentration of buprenorphine, potentially resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence … monitor for signs of respiratory depression. Examples: Rifampin, carbamazepine, phenytoin. |
| Pregabalin | drug interactions | Benzodiazepines or Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effects, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, increases the risk of respiratory depression, profound sedation, coma, and death. … relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. |
| Rifampin | drug interactions | CYP3A4 Inducers Clinical Impact: The concomitant use of buprenorphine and CYP3A4 inducers can decrease the plasma concentration of buprenorphine, potentially resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence … dosage reduction and monitor for signs of respiratory depression. Examples: Rifampin, carbamazepine, phenytoin. |
| Ritonavir | drug interactions | Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir). |
| Tramadol | drug interactions | Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat … |
| Tranylcypromine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). Intervention: The use of Buprenorphine and Naloxone Sublingual Tablets is not recommended for patients taking MAOIs or within 14 days of stopping such treatment. Examples: phenelzine, tranylcypromine, linezolid. |
| Trazodone | drug interactions | Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat … |
Other labels that name buprenorphine and naloxone
Source: FDA drug label (buprenorphine and naloxone), Hikma Pharmaceuticals USA Inc., effective July 26, 2026 (SPL set 713db2c6-0544-4633-b874-cfbeaf93db89), via openFDA; the full label on DailyMed
What do FAERS reports show for buprenorphine and naloxone?
The FDA Adverse Event Reporting System holds 26,265 reports that list buprenorphine and naloxone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,407 are coded as a death and 5,149 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other opioid antagonists
- the pharmacologic class, with prices and generics
- Buprenorphine and naloxone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other