Prescription medicine
Buprenorphine Brand names: Belbuca, Brixadi, Butrans, Sublocade; first approved as Buprenex
Buprenorphine (Belbuca) is a prescription medicine with an FDA approval on record since 1981. FDA's NDC Directory lists it from 27 generic labelers, and pharmacies paid $0.277 per tablet (Buprenorphine 2 mg tablet sl) in the October 7, 2026 NADAC survey; its other strengths are brand-only, $7.54 per Belbuca 75 mcg film.
- Generic listed
- DEA Schedule III
Check it at the source: the buprenorphine FDA label on DailyMed (effective June 5, 2026); the NDA 18401 record on Drugs@FDA; every buprenorphine label on DailyMed.
Highlights of the record
FDA label of June 5, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageBuprenorphine sublingual tablets are indicated for the treatment of opioid dependence and are preferred for induction.
Forms and strengths
- 2 mg
- 4 mg
- 8 mg
- 12 mg
- 300 mg
- 0.3 mg/ml
- 0.324 mg/ml
- 8 mg/.16ml
- 24 mg/.48ml
- 32 mg/.64ml
- 64 mg/.18ml
- 96 mg/.27ml
Tablet; extended-release patch; injection; soluble film; patch.
On the market
- Earliest approval on file
- December 29, 1981 Buprenex, Indivior; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 20 first June 3, 1996; 16 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 31 of which 27 under generic applications, 4 under brand applications, repackagers included
- Last listed patent
- December 21, 2032 Belbuca film; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.277 per tablet Buprenorphine 2 mg tablet sl
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 12 since 2013 0 Class I among all firms' recalls; latest August 19, 2026; 4 more by firms not listed as its makers
- FAERS reports
- 99,861 through July 30, 2026
What is buprenorphine used for?
From the label: indications and usageBuprenorphine sublingual tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. Buprenorphine sublingual tablets contain buprenorphine, a partial opioid agonist, and are indicated for the treatment of opioid dependence and are preferred for induction. ( 1 ) Buprenorphine 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's FDA labels, with every medicine labeled for each:
From other buprenorphine labelsPain: Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate release opioids.
FDA pharmacologic class: Partial Opioid Agonist.
Source: FDA drug label (Buprenorphine HCl), SpecGx LLC, effective June 5, 2026 (SPL set b60d514d-a88a-4fa2-a5b0-30ac29e04973), via openFDA; the full label on DailyMed
What does the patient leaflet for buprenorphine 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 sublingual tablets?Buprenorphine sublingual tablets contain a medicine called buprenorphine. Buprenorphine is an opioid that can cause serious and life-threatening breathing problems, especially if you take or use certain other medicines or drugs. Talk to your healthcare provider about naloxone. Naloxone is a medicine that is available to patients for the emergency treatment of an opioid overdose, including accidental use of buprenorphine sublingual tablets by a child. If naloxone is given, you must call 911 or get emergency medical help right away to treat an overdose or accidental use of an opioid. Buprenorphine sublingual tablets may cause serious and life-threatening breathing problems. Get emergency help right away if you: feel faint feel dizzy are confused feel sleepy or uncoordinated have blurred vision have slurred speech are breathing slower than normal cannot think well or clearly Do not take buprenorphine sublingual tablets with certain medicines. Taking buprenorphine sublingual tablets with other opioid medicines, benzodiazepines, 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 sublingual tablets. Injecting buprenorphine sublingual tablets may cause life-threatening infections and other serious health problems. Do not switch from buprenorphine sublingual tablets to other medicines that contain buprenorphine without talking with your healthcare provider. The amount of buprenorphine in a dose of buprenorphine sublingual tablets is not the same as in other medicines that contain buprenorphine. […]
From the patient leaflet: What should I avoid while taking buprenorphine sublingual tablets?Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how buprenorphine sublingual tablets affect you. Buprenorphine can cause drowsiness and slow reaction times. Buprenorphine 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 sublingual tablets, because this can lead to loss of consciousness or even death.
Source: FDA drug label (Buprenorphine HCl), SpecGx LLC, effective June 5, 2026 (SPL set b60d514d-a88a-4fa2-a5b0-30ac29e04973), via openFDA; the full label on DailyMed
Is there a generic for buprenorphine (Belbuca)?
The FDA approved the first generic buprenorphine on June 3, 1996. 20 generic applications are approved; 16 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists buprenorphine from 27 labelers under a generic (ANDA) application and from 4 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 Belbuca film, the last expiring on December 21, 2032; a patent listed only for Sublocade injection runs to June 22, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1981 earliest approval on file
- 1996 first generic approved
- 2032 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 (Belbuca)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.277 per tablet (Buprenorphine 2 mg tablet sl), down 11% from $0.310 on October 8, 2025. 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 2 mg tablet sl (generic)
- Belbuca 75 mcg film (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Buprenorphine 10 mcg/hr patch | Generic | $32.53 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -8% |
| Buprenorphine 15 mcg/hr patch | Generic | $53.78 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +7% |
| Buprenorphine 2 mg tablet sl | Generic | $0.277 per tablet | $8.30 | -11% |
| Buprenorphine 20 mcg/hr patch | Generic | $58.83 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +1% |
| Buprenorphine 5 mcg/hr patch | Generic | $23.45 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +10% |
| Buprenorphine 7.5 mcg/hr patch | Generic | $37.68 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +5% |
| Buprenorphine 8 mg tablet sl | Generic | $0.571 per tablet | $17.14 | -20% |
| Belbuca 150 mcg film | Brand | $7.56 per film many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +5% |
| Belbuca 300 mcg film | Brand | $11.86 per film many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +5% |
| Belbuca 450 mcg film | Brand | $16.11 per film many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +5% |
| Belbuca 600 mcg film | Brand | $17.19 per film many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +5% |
| Belbuca 75 mcg film | Brand | $7.54 per film many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +5% |
| Belbuca 750 mcg film | Brand | $18.10 per film many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +5% |
| Belbuca 900 mcg film | Brand | $18.59 per film many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has buprenorphine been recalled?
The FDA's Enforcement Report lists 16 recalls naming buprenorphine since 2013: 0 Class I (the most serious), 15 Class II, 1 Class III; 5 still ongoing. 4 of them are by firms that FDA's NDC Directory does not list as a maker of buprenorphine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 19, 2026 | Class III | American Health Packaging | Labeling: Label Mix-up |
| June 12, 2026 | Class II | Par Health USA, LLC | Crystallization; identified as Buprenorphine free base |
| March 13, 2026 | Class II | ENDO USA, Inc. | Crystallization; identified as Buprenorphine free base |
| May 20, 2024 | Class II | Pfizer Inc. | Lack of Assurance of Sterility-The potential for incomplete crimp seals. |
| May 3, 2023 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | CGMP Deviations |
| December 22, 2022 | Class II | Pharmacy Innovations not a listed maker | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. |
| November 9, 2021 | Class II | PAR Sterile Products LLC | Crystallization; identified as Buprenorphine free base |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the buprenorphine label say about other medicines?
The buprenorphine label names 30 other medicines in its interaction, contraindication or warning sections. The labels of 37 other medicines name buprenorphine. 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 sublingual tablets and atazanavir with and without ritonavir, and reduce dose of buprenorphine sublingual tablets if warranted. Examples: Atazanavir, ritonavir |
| Butorphanol | drug interactions | Clinical Impact: May reduce the analgesic effect of BUTRANS and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine Muscle Relaxants |
| 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 | Inhibitors of CYP3A4 Clinical Impact: The concomitant use of buprenorphine and CYP3A4 inhibitors can increase the plasma concentration of buprenorphine, resulting in increased or prolonged opioid effects, particularly when an inhibitor is added after a stable dose of … Monitor for signs of opioid withdrawal. Examples: 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 and 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), and other opioids. |
| Ketoconazole | drug interactions | Inhibitors of CYP3A4 Clinical Impact: The concomitant use of buprenorphine and CYP3A4 inhibitors can increase the plasma concentration of buprenorphine, resulting in increased or prolonged opioid effects, particularly when an inhibitor is added after a stable dose of … 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 | 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 sublingual tablets and atazanavir with and without ritonavir, and reduce dose of buprenorphine 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 of the partial agonist properties of buprenorphine, BRIXADI injection may precipitate opioid withdrawal signs and symptoms in individuals physically dependent on full opioid agonists such as heroin, morphine, or methadone before the effects of the full opioid agonist have subsided. |
| 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). |
Every other medicine the buprenorphine label names
| Medicine named | Section | What the label says |
|---|---|---|
| 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 … |
| Morphine | warnings and precautions | … individuals physically dependent on full opioid agonists such as heroin, morphine, or methadone before the effects of the full opioid agonist have subsided. |
| Nalbuphine | drug interactions | Clinical Impact: May reduce the analgesic effect of BUTRANS and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine Muscle Relaxants |
| 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. |
| Naloxone | 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. … Precautions (,)]. If concomitant use is warranted, strongly consider prescribing naloxone for the emergency treatment of opioid overdose, as is recommended for all patients in treatment for opioid use disorder [see … |
| 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 sublingual tablets and atazanavir with and without ritonavir, and reduce dose of buprenorphine sublingual tablets if warranted. Examples: Atazanavir, ritonavir |
| 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 sublingual tablets is not recommended for patients taking MAOIs or within 14 days of stopping such treatment. Examples: Phenelzine, tranylcypromine, linezolid |
| Phenobarbital | drug interactions | Clinical Impact: The effects of co-administered CYP3A4 inducers on buprenorphine exposure in patients treated with BRIXADI have not been studied. Buprenorphine is metabolized to norbuprenorphine primarily by CYP3A4; … [see Clinical Pharmacology (12.3) ]. Rifampin, carbamazepine, phenytoin, phenobarbital Antiretrovirals: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) |
| 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 and 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), and other opioids. |
| 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 | Inhibitors of CYP3A4 Clinical Impact: The concomitant use of buprenorphine and CYP3A4 inhibitors can increase the plasma concentration of buprenorphine, resulting in increased or prolonged opioid effects, particularly when an inhibitor is added after a stable dose of … 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 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
Source: FDA drug label (Buprenorphine HCl), SpecGx LLC, effective June 5, 2026 (SPL set b60d514d-a88a-4fa2-a5b0-30ac29e04973), via openFDA; the full label on DailyMed
What do FAERS reports show for buprenorphine?
The FDA Adverse Event Reporting System holds 99,861 reports that list buprenorphine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 27,352 are coded as a death and 12,277 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 rose sharply in 2018 (23,213, against a median of 5,160 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
How does buprenorphine compare with medicines for the same use?
2 side-by-side pages set buprenorphine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other partial opioid agonists
- the pharmacologic class, with prices and generics
- Buprenorphine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other