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Buprenorphine

Buprenorphine is a partial opioid medicine used to treat opioid use disorder (opioid dependence) and to manage severe, persistent pain, depending on the product and form.

Brand names ButransSimbadolBelbucaSublocadeBuprenex +5 more
Drug class Partial Opioid Agonists
Rx Schedule CIII Forms 4
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 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 39 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 6, 2026 🚨Recall on record · 4
Other forms & routes:
Transdermal
Buprenorphine 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

Buprenorphine is a partial opioid (it only partly switches on the brain's main opioid receptor), a standard first choice for opioid use disorder that is also used for severe, persistent pain, on the market since about 1996 and available as a generic. Most people tolerate it fairly well, and nausea, headache, constipation and sleepiness are what they notice most. Its boxed warning centers on life-threatening slowed breathing, most likely when starting, after a dose increase, or with alcohol, benzodiazepines or other sedating drugs, and a child who gets into any form can die. If it is for opioid use disorder, ask your pharmacist about keeping naloxone, the overdose-reversal spray, at home.

Clinical pearls

  • Let the under-the-tongue tablet dissolve completely without chewing, crushing or swallowing it, or much of the dose is lost.
  • Keep heating pads, electric blankets, saunas and hot tubs off the patch, and report fevers, since heat raises drug levels.
  • Ritonavir, erythromycin and ketoconazole can raise its levels, while rifampin, carbamazepine and phenytoin can lower them enough to cause withdrawal.
  • Gabapentin, pregabalin, sleep aids and muscle relaxants count as sedating drugs too, so mention them before starting any new prescription.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asSublingual tablet, Skin patch, Injection +1
Earliest FDA record1981
Companies listing it with the FDA31
FDA label last updatedMay 25, 2026
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Buprenorphine, written from its FDA label.

What Buprenorphine is used for

▾

Buprenorphine is used for opioid use disorder and for pain, depending on the product.

  • Sublingual tablets: opioid dependence, preferred for induction, with counseling and support.
  • Sublocade (subcutaneous): moderate to severe opioid use disorder.
  • Brixadi (subcutaneous): moderate to severe opioid use disorder.
  • Belbuca (buccal film): severe, persistent pain needing an opioid.
  • Butrans and buprenorphine skin patches: severe, persistent pain needing an opioid.
  • Buprenorphine hydrochloride injection: pain severe enough to need an opioid when other treatments are inadequate.

How Buprenorphine works

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Buprenorphine is a partial agonist at the mu-opioid receptor, so it activates the receptor only partly. It also blocks kappa-opioid receptors and acts on delta and ORL-1 (nociceptin) receptors. How much each action contributes to pain relief is unclear.

Buprenorphine dosage

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Dosing depends on the product, so follow your prescriber and the label.

  • Sublingual tablets: once daily under the tongue, kept whole.
  • Skin patch: worn for 7 days at a time.
  • Belbuca: a film placed inside the cheek.
  • Sublocade and Brixadi: injected under the skin by a healthcare provider only.
  • Buprenorphine hydrochloride injection: given into a muscle or vein.

Dosing details from the FDA-approved label

From the Buprenorphine 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.

  • Opioid use disorder - induction, patients dependent on heroin or other short-acting opioid products
    • First dose administered only when objective and clear signs of moderate opioid withdrawal appear, and not less than 4 hours after the patient last used an opioid
    • Dosing on the initial day may be given in 2 mg to 4 mg increments if preferred
    • In a one-month study, 8 mg on Day 1 and 16 mg on Day 2
  • Opioid use disorder - induction, patients dependent on methadone or other long-acting opioid products
    • First dose administered only when objective and clear signs of moderate opioid withdrawal appear, and generally not less than 24 hours after the patient last used a long-acting opioid product
    • Withdrawal appears more likely in patients maintained on higher doses of methadone (>30 mg) and when the first buprenorphine dose is given shortly after the last methadone dose
  • Opioid use disorder - maintenance (patients who cannot tolerate naloxone)
    • After induction to the recommended dose of 16 mg buprenorphine per day, adjust based on individual patient and clinical response, in increments/decrements of 2 mg or 4 mg
    • Maintenance dose generally in the range of 4 mg to 24 mg buprenorphine per day
    • Maximum: Dosages higher than 24 mg daily have not been investigated in randomized clinical trials
    • Buprenorphine and naloxone sublingual tablets are preferred for maintenance
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION • Administer Buprenorphine Sublingual Tablets sublingually as a single daily dose. ( 2.1 ) • Strongly consider recommending or prescribing an opioid overdose reversal agent (e.g., naloxone, nalmefene) at the time Buprenorphine Sublingual Tablets are initiated or renewed because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose. ( 2.2 ) • To avoid precipitating withdrawal, induction with Buprenorphine Sublingual Tablets should be undertaken when objective and clear signs of withdrawal are evident. ( 2.3 ) • Buprenorphine and naloxone sublingual film or buprenorphine and naloxone sublingual tablets are generally initiated after two days of Buprenorphine Sublingual Tablet titration. ( 2.4 ) • Administer Buprenorphine Sublingual Tablets as directed in the Full Prescribing Information. ( 2.3 , 2.4 , 2.5 ) • Buprenorphine Sublingual Tablets must be administered whole. Do not cut, chew, or swallow Buprenorphine Sublingual Tablets. ( 2.5 ) • When discontinuing treatment, gradually taper to avoid signs and symptoms of withdrawal. ( 2.9 ) 2.1 Important Dosage and Administration Instructions Buprenorphine Sublingual Tablets are administered sublingually as a single daily dose. Buprenorphine Sublingual Tablets do not contain naloxone and is preferred for use only during induction. Following induction, buprenorphine and naloxone sublingual film or buprenorphine and naloxone sublingual tablets are preferred due to the presence of naloxone when clinical use includes unsupervised administration. The use of Buprenorphine Sublingual Tablets for unsupervised administration should be limited to those patients who cannot tolerate buprenorphine and naloxone sublingual film or buprenorphine and naloxone sublingual tablets; for example, those patients who have been shown to be hypersensitive to naloxone. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised early in treatment or without appropriate patient follow-up visits. 2.2 Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene) and discuss the importance of having access to an opioid overdose reversal agent.

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

Buprenorphine side effects

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Common side effects with the buprenorphine patch include:

Common side effects

  • Nausea
  • Headache
  • Dizziness
  • Constipation
  • Sleepiness
  • Vomiting
  • Dry mouth
  • Itching, redness or rash at the patch site (skin patch)

When to get medical help

  • Slow or shallow breathing, extreme sleepiness, or trouble waking up: call 911 right away
  • Suspected overdose, including accidental exposure in a child: get emergency help immediately
  • Severe skin reaction at the patch site, such as burning, discharge or blisters: report it promptly
  • Signs of an allergic reaction, such as swelling or trouble breathing
  • Fainting or severe lightheadedness
  • Pain that gets worse or becomes more sensitive while on the medicine
  • Signs of serotonin syndrome if taken with other serotonergic drugs
  • Withdrawal symptoms in a newborn if used for a long time in pregnancy

Buprenorphine warnings and precautions

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  • Slowed breathing can be life-threatening, especially when starting or after a dose increase.
  • Addiction, abuse and misuse can happen even at prescribed doses.
  • Accidental exposure, especially in children, can be fatal.
  • Alcohol and sedating drugs greatly raise the risk of coma and death.
  • Heat or fever can raise drug levels from the patch.
  • Long-term use in pregnancy can cause newborn withdrawal.
  • Opioids can sometimes make pain worse (hyperalgesia).

Buprenorphine interactions

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Several drugs can change how buprenorphine works or raise its risks.

  • Alcohol, benzodiazepines, gabapentinoids and other sedatives: extreme sleepiness and slowed breathing.
  • CYP3A4 inhibitors (ketoconazole, erythromycin, ritonavir, atazanavir): higher buprenorphine levels.
  • CYP3A4 inducers (rifampin, carbamazepine, phenytoin, phenobarbital): lower levels and possible withdrawal.
  • MAO inhibitors: Sublocade is not recommended within 14 days.
  • Serotonergic drugs (SSRIs, SNRIs, triptans, tramadol): risk of serotonin syndrome.
  • Muscle relaxants: added breathing risk.
  • Diuretics: may work less well.

Interactions listed in the FDA-approved label

From the Buprenorphine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Benzodiazepines and other CNS depressants (including alcohol): Additive pharmacologic effects increase the risk of respiratory depression, profound sedation, coma, and death. Cessation of benzodiazepines or other CNS depressants is preferred in most cases; otherwise taper gradually or decrease to the lowest effective dose; if concomitant use is warranted, strongly consider recommending or prescribing an opioid overdose reversal agent.
  • CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir): Can increase the plasma concentration of buprenorphine, resulting in increased or prolonged opioid effects. Monitor for signs and symptoms of over-medication when newly started; monitor for withdrawal if the inhibitor is discontinued.
  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital): May increase clearance of buprenorphine, which could lead to decreased plasma concentrations, lack of efficacy or possibly an abstinence syndrome. Monitor for withdrawal if newly initiated; monitor for signs and symptoms of over-medication if the inducer is discontinued.
  • Non-nucleoside reverse transcriptase inhibitors (efavirenz, nevirapine, etravirine, delavirdine): Significant pharmacokinetic interactions were shown with sublingual buprenorphine, but did not result in significant pharmacodynamic effects. Monitor for increase or decrease in therapeutic effects if NNRTIs are added.
  • Antiretroviral protease inhibitors (atazanavir, atazanavir/ritonavir): Elevated levels of buprenorphine and norbuprenorphine, increased sedation and symptoms of opioid excess were reported; nelfinavir, lopinavir/ritonavir and ritonavir had little effect. If atazanavir with or without ritonavir must be initiated, monitor for signs and symptoms of over-medication.
  • Nucleoside reverse transcriptase inhibitors (NRTIs): Do not appear to induce or inhibit the P450 enzyme pathway, so no interactions with buprenorphine are expected. None
  • Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, mirtazapine, trazodone, tramadol, etc.): Concomitant use of opioids with drugs affecting the serotonergic system has resulted in serotonin syndrome. If concomitant use is warranted, carefully monitor for signs and symptoms of serotonin syndrome, particularly during initiation and dose adjustment.
  • Monoamine oxidase inhibitors (MAOIs) (phenelzine, tranylcypromine, linezolid): May manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma). Use is not recommended in patients taking MAOIs or within 14 days of stopping such treatment.
  • Muscle relaxants: Buprenorphine may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce increased respiratory depression. Monitor for respiratory depression and decrease the muscle relaxant dosage as necessary; strongly consider recommending or prescribing an opioid overdose reversal agent.
  • Diuretics: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Monitor patients for signs of diminished diuresis and/or effects on blood pressure.
Read the label’s full interactions text

7 DRUG INTERACTIONS Table 3 includes clinically significant drug interactions with Buprenorphine Sublingual Tablets. Table 3. Clinically Significant Drug Interactions with Buprenorphine Sublingual Tablets 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. Intervention: Cessation of benzodiazepines or other CNS depressants is preferred in most cases of concomitant use. In some cases, monitoring in a higher level of care for taper may be appropriate. In others, gradually tapering a patient off of a prescribed benzodiazepine or CNS depressant or decreasing to the lowest effective dose may be appropriate. Before co-prescribing benzodiazepines for anxiety or insomnia, ensure that patients are appropriately diagnosed and consider alternative medications and non-pharmacologic treatments [see Warnings and Precautions ( 5.2 , 5.3 )] . If concomitant use is warranted, strongly consider recommending or prescribing an opioid overdose reversal agent, as is recommended for all patients on buprenorphine treatment for opioid use disorder [see Warnings and Precautions ( 5.2 )]. Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. 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 Buprenorphine Sublingual Tablets is achieved.

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 Buprenorphine against a supplement or herb →

Before taking Buprenorphine

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  • Not for people with significant breathing problems, a bowel blockage or an allergy to buprenorphine (patch labeling).
  • Tell your prescriber about asthma or lung disease.
  • Mention any history of substance misuse or mental illness.
  • Severe liver problems may need a lower starting dose.
  • Older adults need monitoring for sedation and slowed breathing.
  • Discuss pregnancy; buprenorphine passes into breast milk.

Buprenorphine overdose

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Overdose can cause slowed breathing, deep sleepiness progressing to coma, limp muscles, cold clammy skin and pinpoint pupils. Call 911 right away. For the patch, remove it immediately; monitoring for at least 24 hours may be needed. Naloxone may be less effective against buprenorphine, so emergency care is essential.

What Buprenorphine does in the body

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Buprenorphine slows breathing by acting on the brainstem's breathing centers. It causes small pupils, slows digestion and causes constipation. It widens blood vessels, which can lower blood pressure and cause fainting. Long-term opioid use may lower sex hormones. At high patch doses, it can slightly lengthen the QTc interval.

How your body processes Buprenorphine

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Each buprenorphine patch delivers medicine for 7 days, reaching steady levels by about day 3. Drug is usually detectable about 17 hours after application. Buprenorphine is processed mainly by the liver enzyme CYP3A4 and cleared through bile into stool and through urine. After a patch is removed, levels fall about 50% in 12 hours.

How to store Buprenorphine

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store Buprenorphine Sublingual Tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home .

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

Buprenorphine: pharmacist answers to common questions

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

What is buprenorphine used for?

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It depends on the product. Sublingual tablets, Sublocade and Brixadi treat opioid dependence. Belbuca, Butrans, patches and the injection treat severe pain that needs an opioid.

How should I take it?

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Follow your label exactly. Sublingual tablets dissolve under the tongue once daily and must not be chewed or swallowed. Patches stay on for 7 days, and injections are given by a provider.

What side effects should I expect?

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Nausea, headache, dizziness, constipation, sleepiness and dry mouth are common. With patches, you may get itching or redness at the site. Call for help if breathing slows or you can't stay awake.

Can I drink alcohol or take sleep or anxiety medicines with it?

▾
No, not without your prescriber's guidance. Alcohol, benzodiazepines and other sedatives can cause dangerous sedation, slowed breathing, coma and death.

Can I use a heating pad over my patch?

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No. Heat can make your body absorb more medicine and cause overdose. Also avoid saunas, hot tubs and electric blankets over the patch, and tell your prescriber if you have a fever.

Is it safe in pregnancy?

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Talk to your prescriber. Long-term use can cause withdrawal in newborns, so doctors will plan for that. Untreated opioid addiction in pregnancy also carries risks.

Is Buprenorphine available over the counter?

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No. Buprenorphine is a prescription medicine: every Buprenorphine 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.

Is Buprenorphine a controlled substance?

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Yes — Buprenorphine 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 first available?

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The earliest FDA record we hold for Buprenorphine is from 1981: 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 Buprenorphine was first used.

Who makes Buprenorphine?

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31 companies currently list Buprenorphine products in the FDA's NDC Directory, including BioDelivery Sciences International Inc, Braeburn Inc., Bryant Ranch Prepack. 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 Buprenorphine on HelloPharmacist

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

Buprenorphine forms and strengths (how it comes)

Buprenorphine is available in 4 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.

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

Sublingual tablet

Under the tongue
Brands Buprenorphine Sublingual Buprenorphine Sublingual C-III
How this form is used
What it may be used for
  • Buprenorphine sublingual tablets are used for opioid dependence and are preferred for induction, along with counseling and support.
Important instructions
  • Buprenorphine sublingual tablets are taken under the tongue as a single daily dose.
  • Buprenorphine HCl sublingual tablets must be kept whole: don't cut, chew or swallow them.
  • Buprenorphine sublingual tablets do not contain naloxone and are preferred only during induction.
Available strengths 4 strengths
2 mg 4 mg 8 mg 12 mg
104 FDA-listed product records ⓘ

Skin patch

Through the skin
Brands Buprenorphine Transdermal System Butrans
How this form is used
What it may be used for
  • Butrans is used for severe, persistent pain that needs an opioid and can't be managed with other options.
  • Buprenorphine transdermal system is used for severe, persistent pain; it is not for as-needed use.
Important instructions
  • Butrans and buprenorphine transdermal system patches should be prescribed only by professionals experienced with extended-release opioids.
  • Each buprenorphine transdermal system patch delivers medicine for 7 days.
  • Avoid heating pads, electric blankets, saunas and hot tubs on the patch area.
Available strengths 10 strengths
5 mcg/h BUPRENORPHINE 5 mcg/h 7.5 mcg/h BUPRENORPHINE 7.5 mcg/h 10 mcg/h BUPRENORPHINE 10 mcg/h
Show 4 more strengths Show fewer strengths
15 mcg/h BUPRENORPHINE 15 mcg/h 20 mcg/h BUPRENORPHINE 20 mcg/h
94 FDA-listed product records ⓘ

Injection

Into a muscle · Into a vein · Under the skin
Brands Brixadi Sublocade
How this form is used
What it may be used for
  • Sublocade is used for moderate to severe opioid use disorder, along with counseling and support.
  • Brixadi is used for moderate to severe opioid use disorder, along with counseling and support.
  • Buprenorphine hydrochloride injection is used for pain severe enough to need an opioid when other treatments are inadequate.
Important instructions
  • Sublocade is prepared and given only by a healthcare provider, as an injection under the skin.
  • Brixadi is given only by a healthcare provider, as a slow injection under the skin.
  • Brixadi weekly and monthly are different formulations, and their doses can't be combined.
  • Buprenorphine hydrochloride injection is given into a muscle or vein.
Available strengths 11 strengths
0.3 mg/mL 0.324 mg/mL 8 mg/0.16 mL 16 mg/0.32 mL 24 mg/0.48 mL 32 mg/0.64 mL
Show 5 more strengths Show fewer strengths
64 mg/0.18 mL 96 mg/0.27 mL 100 mg 128 mg/0.36 mL 300 mg
29 FDA-listed product records ⓘ

Buccal film

Inside the cheek
Brands Belbuca
How this form is used
What it may be used for
  • Belbuca is used for severe, persistent pain that needs an opioid and can't be managed with other options, including immediate-release opioids.
  • Belbuca is not for as-needed pain relief.
Important instructions
  • Belbuca should be prescribed only by professionals experienced with extended-release opioids.
  • Belbuca is used at the lowest effective dose for the shortest time.
  • Breathing problems can occur at any time with Belbuca, especially at the start or after a dose increase.
Available strengths 7 strengths
75 mcg 150 mcg 300 mcg 450 mcg 600 mcg 750 mcg
Show 1 more strength Show fewer strengths
900 mcg
21 FDA-listed product records ⓘ

Buprenorphine on the U.S. market: products, makers and brands

How Buprenorphine 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.

31 companies list 106 Buprenorphine product records with the FDA, mostly as sublingual tablet, skin patch, injection; the earliest marketing or approval year on record is 1981. Brand names on the directory include Butrans, Simbadol, Belbuca and 7 more; the rest are generics.

4
Dose forms ⓘ
31
Labelers (makers, repackagers, distributors)
10
Brand names
106
FDA-listed product records ⓘ
1981
Earliest FDA record ⓘ

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

Also listed with the FDA, not a patient dose form: Powder (45) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

BioDelivery Sciences International Inc7%
Braeburn Inc.7%
Bryant Ranch Prepack7%
Rhodes Pharmaceuticals LLC7%
Clinical Solutions Wholesale, LLC6%
Amneal Pharmaceuticals NY LLC5%
Other makers63%

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

How widely Buprenorphine is used (Medicaid data)

A general measure of how commonly Buprenorphine 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 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.

1,379,027
Medicaid prescriptions filled (Q1–Q4 2025)
$984.4M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Buprenorphine prescribed? Of the 1,601 medications we measure, Buprenorphine ranks #134 by Medicaid prescriptions — more than 92% of them.

Where Buprenorphine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #134 of 1,601
#129 Atomoxetine 1,684,860 Rx #130 Sumatriptan 1,522,413 Rx #131 Clopidogrel 1,480,259 Rx #132 Zolpidem 1,428,857 Rx #133 Glipizide 1,400,626 Rx #134 Buprenorphine Buccal (... 1,379,027 Rx #135 Buprenorphine 1,379,027 Rx #136 Chlorhexidine 1,373,852 Rx #137 Simvastatin 1,357,663 Rx #138 Tretinoin 1,345,058 Rx #139 Tretinoin Topical 1,344,781 Rx

Utilization by Buprenorphine 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 sublingual tablet is the most-dispensed Buprenorphine product — about 46% of these Medicaid prescriptions.

buprenorphine 8 MG Sublingual Tablet Most dispensed

630,724 Medicaid prescriptions (Q1–Q4 2025) 46% of Buprenorphine prescriptions shown $29.9M gross reimbursement (before rebates) ≈ $47 per prescription (gross)

Summed across the 8 of 85 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 351265

1.5 ML buprenorphine 200 MG/ML Prefilled Syringe

221,541 Medicaid prescriptions (Q1–Q4 2025) 16% of Buprenorphine prescriptions shown $441.7M gross reimbursement (before rebates) ≈ $1,994 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1996192

0.5 ML buprenorphine 200 MG/ML Prefilled Syringe

113,583 Medicaid prescriptions (Q1–Q4 2025) 8% of Buprenorphine prescriptions shown $230.4M gross reimbursement (before rebates) ≈ $2,029 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1996184

buprenorphine 2 MG Sublingual Tablet

106,539 Medicaid prescriptions (Q1–Q4 2025) 8% of Buprenorphine prescriptions shown $3M gross reimbursement (before rebates) ≈ $28 per prescription (gross)

Summed across the 8 of 65 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 351264

0.36 ML buprenorphine 356 MG/ML Prefilled Syringe

57,502 Medicaid prescriptions (Q1–Q4 2025) 4% of Buprenorphine prescriptions shown $94.5M gross reimbursement (before rebates) ≈ $1,644 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 2639043

0.27 ML buprenorphine 356 MG/ML Prefilled Syringe

35,529 Medicaid prescriptions (Q1–Q4 2025) 3% of Buprenorphine prescriptions shown $58.9M gross reimbursement (before rebates) ≈ $1,658 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 2639041

168 HR buprenorphine 0.01 MG/HR Transdermal System

29,227 Medicaid prescriptions (Q1–Q4 2025) 2% of Buprenorphine prescriptions shown $7.5M gross reimbursement (before rebates) ≈ $257 per prescription (gross)

Summed across the 5 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 904870

168 HR buprenorphine 0.02 MG/HR Transdermal System

27,738 Medicaid prescriptions (Q1–Q4 2025) 2% of Buprenorphine prescriptions shown $12.5M gross reimbursement (before rebates) ≈ $451 per prescription (gross)

Summed across the 6 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 904876

168 HR buprenorphine 0.015 MG/HR Transdermal System

21,299 Medicaid prescriptions (Q1–Q4 2025) 2% of Buprenorphine prescriptions shown $9.2M gross reimbursement (before rebates) ≈ $432 per prescription (gross)

Summed across the 5 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1432969

0.18 ML buprenorphine 356 MG/ML Prefilled Syringe

20,591 Medicaid prescriptions (Q1–Q4 2025) 1% of Buprenorphine prescriptions shown $33.5M gross reimbursement (before rebates) ≈ $1,628 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 2639036

168 HR buprenorphine 0.005 MG/HR Transdermal System

16,459 Medicaid prescriptions (Q1–Q4 2025) 1% of Buprenorphine prescriptions shown $2.8M gross reimbursement (before rebates) ≈ $169 per prescription (gross)

Summed across the 5 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 904880

buprenorphine 0.3 MG Buccal Film

10,931 Medicaid prescriptions (Q1–Q4 2025) <1% of Buprenorphine prescriptions shown $6.9M gross reimbursement (before rebates) ≈ $634 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 1716065

0.48 ML buprenorphine 50 MG/ML Prefilled Syringe

10,635 Medicaid prescriptions (Q1–Q4 2025) <1% of Buprenorphine prescriptions shown $5.5M gross reimbursement (before rebates) ≈ $516 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 2639031

168 HR buprenorphine 0.0075 MG/HR Transdermal System

10,566 Medicaid prescriptions (Q1–Q4 2025) <1% of Buprenorphine prescriptions shown $2.7M gross reimbursement (before rebates) ≈ $252 per prescription (gross)

Summed across the 5 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1542997

0.64 ML buprenorphine 50 MG/ML Prefilled Syringe

10,557 Medicaid prescriptions (Q1–Q4 2025) <1% of Buprenorphine prescriptions shown $5.5M gross reimbursement (before rebates) ≈ $520 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 2639033

buprenorphine 0.45 MG Buccal Film

9,203 Medicaid prescriptions (Q1–Q4 2025) <1% of Buprenorphine prescriptions shown $7.9M gross reimbursement (before rebates) ≈ $862 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1716069

buprenorphine 0.9 MG Buccal Film

8,820 Medicaid prescriptions (Q1–Q4 2025) <1% of Buprenorphine prescriptions shown $9M gross reimbursement (before rebates) ≈ $1,024 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 1716086

buprenorphine 0.15 MG Buccal Film

8,800 Medicaid prescriptions (Q1–Q4 2025) <1% of Buprenorphine prescriptions shown $3.5M gross reimbursement (before rebates) ≈ $397 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 1716057

buprenorphine 0.6 MG Buccal Film

8,076 Medicaid prescriptions (Q1–Q4 2025) <1% of Buprenorphine prescriptions shown $7.5M gross reimbursement (before rebates) ≈ $927 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 1716073

0.32 ML buprenorphine 50 MG/ML Prefilled Syringe

5,871 Medicaid prescriptions (Q1–Q4 2025) <1% of Buprenorphine prescriptions shown $3M gross reimbursement (before rebates) ≈ $507 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 2639029

0.16 ML buprenorphine 50 MG/ML Prefilled Syringe

5,040 Medicaid prescriptions (Q1–Q4 2025) <1% of Buprenorphine prescriptions shown $2.5M gross reimbursement (before rebates) ≈ $488 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 2639021

buprenorphine 0.75 MG Buccal Film

4,849 Medicaid prescriptions (Q1–Q4 2025) <1% of Buprenorphine prescriptions shown $4.8M gross reimbursement (before rebates) ≈ $989 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 1716081

buprenorphine 0.075 MG Buccal Film

4,536 Medicaid prescriptions (Q1–Q4 2025) <1% of Buprenorphine prescriptions shown $1.7M gross reimbursement (before rebates) ≈ $373 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 1716077

1 ML buprenorphine 0.3 MG/ML Injection

384 Medicaid prescriptions (Q1–Q4 2025) <1% of Buprenorphine prescriptions shown $5,419 gross reimbursement (before rebates) ≈ $14 per prescription (gross)

Summed across the 1 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 238129

1 ML buprenorphine 0.3 MG/ML Cartridge

27 Medicaid prescriptions (Q1–Q4 2025) <1% of Buprenorphine prescriptions shown

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1655032

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, 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 60 of 249 listed Buprenorphine NDCs with Medicaid activity.

Compare Buprenorphine products

A representative set of FDA-listed product records for Buprenorphine — 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 106 of 106 products — FDA National Drug Code Directory. See every product, package size and price: browse all 106 Buprenorphine NDCs →

Buprenorphine side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Buprenorphine — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Buprenorphine are drug dependence, death, overdose; about 61% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

124,273
Reports mentioning it
61%
Reported as serious
12
Distinct effects shown
Most reported effects
Drug Dependence
16,378
Death
14,200
Overdose
14,042
Toxicity To Various Agents
11,449
Pain
10,907
Drug Withdrawal Syndrome
10,189
Emotional Distress
6,722
Nausea
6,716
Drug Abuse
4,985
Vomiting
4,112
Age groups
Adult · 4,957Elderly · 1,697Neonate · 1,079Child · 103Infant · 93Adolescent · 61

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Buprenorphine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Buprenorphine FDA approval history

How Buprenorphine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Buprenorphine was first approved by the FDA in 1981 (Brand: BUPRENEX · Indivior); the first generic version was approved in 1996. It remains available in U.S. pharmacies today.

1981
Brand approved
Brand: BUPRENEX · Indivior
1996
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Buprenorphine 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 6 Buprenorphine recalls since July 2021. Four of them are still ongoing or began in the last six months and are listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class III Aug 19, 2026 · American Health Packaging
Labeling: Label Mix-up
  • Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC#: 60687-481-21, (Individual Dose NDC: 60687-481… Lots: Lot # 1030023, Exp Date: 06/30/2027. FDA record D-0840-2026 →
Ongoing Class II Jun 12, 2026 · Par Health USA, LLC
Crystallization; identified as Buprenorphine free base
  • Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05 Lots: Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027 FDA record D-0596-2026 →
Ongoing Class II Mar 13, 2026 · ENDO USA, Inc.
Crystallization; identified as Buprenorphine free base
  • Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05. Lots: Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027 FDA record D-0527-2026 →
Ongoing Class II May 20, 2024 · Pfizer Inc.
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
  • Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular or Intravenous Use, Rx Only, Distributed by Hospira, Inc.,… Lots: Lot#: HJ3965; Exp 2024/09 Lot#: HJ8546; Exp 2024/10 FDA record D-0564-2024 →
Class II May 3, 2023 · Terminated · SUN PHARMACEUTICAL INDUSTRIES INC
CGMP Deviations
  • Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83. Lots: Lot #: DND1515A, Exp 08/24 FDA record D-0869-2023 →
Class II Nov 9, 2021 · Terminated · PAR Sterile Products LLC
Crystallization; identified as Buprenorphine free base
  • Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10… Lots: Lot No: 343716, Exp. Date: 11/2021; Lot No: 350565, Exp. Date: 07/2022; Lot No: 26921, Exp. Date: 07/2022; Lot No: 36227, Exp. Date: 02/2023 FDA record D-0087-2024 →

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

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Buprenorphine RxCUI 1819 8 dose forms · 31 strengths
  1. Dose form (SCDF) Buccal Film RxCUI 1716056 In current FDA listings
    Clinical drug / strength (SCD) 0.075 MG RxCUI 1716077 0.15 MG RxCUI 1716057 0.3 MG RxCUI 1716065 0.45 MG RxCUI 1716069 0.6 MG RxCUI 1716073 0.75 MG RxCUI 1716081 0.9 MG RxCUI 1716086
  2. Dose form (SCDF) Cartridge RxCUI 1655031 No current FDA listing
    Clinical drug / strength (SCD) 1 ML buprenorphine 0.3 MG/ML RxCUI 1655032
  3. Dose form (SCDF) Injectable Solution RxCUI 379112 In current FDA listings
    Clinical drug / strength (SCD) 1.8 MG/ML RxCUI 1594650
  4. Dose form (SCDF) Injection RxCUI 1729358 In current FDA listings
    Clinical drug / strength (SCD) 1 ML buprenorphine 0.3 MG/ML RxCUI 238129
  5. Dose form (SCDF) Prefilled Syringe RxCUI 1996183 No current FDA listing
    Clinical drug / strength (SCD) 0.16 ML buprenorphine 50 MG/ML RxCUI 2639021 0.18 ML buprenorphine 356 MG/ML RxCUI 2639036 0.27 ML buprenorphine 356 MG/ML RxCUI 2639041 0.32 ML buprenorphine 50 MG/ML RxCUI 2639029 0.36 ML buprenorphine 356 MG/ML RxCUI 2639043 0.48 ML buprenorphine 50 MG/ML RxCUI 2639031 0.5 ML buprenorphine 200 MG/ML RxCUI 1996184 0.64 ML buprenorphine 50 MG/ML RxCUI 2639033 1.5 ML buprenorphine 200 MG/ML RxCUI 1996192
  6. Dose form (SCDF) Sublingual Tablet RxCUI 371161 In current FDA listings
    Clinical drug / strength (SCD) 0.2 MG RxCUI 246474 0.4 MG RxCUI 250426 2 MG RxCUI 351264 4 MG RxCUI 2747482 8 MG RxCUI 351265 12 MG RxCUI 2747481
  7. Dose form (SCDF) Topical Solution RxCUI 2599845 No current FDA listing
    Clinical drug / strength (SCD) 20 MG/ML RxCUI 2599846

Look up RxCUI 1819 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.

💵 What Buprenorphine 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 · Sublingual 8 mg $0.571 per tablet NDC details & price history
Tablet · Sublingual 2 mg $0.277 per tablet NDC details & price history
Patch, Extended Release · Transdermal 20 mcg/h $58.83 each NDC details & price history
Patch, Extended Release · Transdermal 5 mcg/h $23.45 each NDC details & price history
Patch, Extended Release · Transdermal 10 mcg/h $32.53 each NDC details & price history
Patch, Extended Release · Transdermal 15 mcg/h $53.78 each NDC details & price history
Patch, Extended Release · Transdermal BUPRENORPHINE 20 mcg/h $58.83 each NDC details & price history
Patch, Extended Release · Transdermal BUPRENORPHINE 15 mcg/h $53.78 each NDC details & price history
Patch, Extended Release · Transdermal BUPRENORPHINE 10 mcg/h $32.53 each NDC details & price history
Patch, Extended Release · Transdermal BUPRENORPHINE 5 mcg/h $23.45 each 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.

Buprenorphine brand names

Buprenorphine is sold under 10 brand names in the FDA directory — Butrans, Simbadol, Belbuca, Sublocade and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Butrans Simbadol Belbuca Sublocade Buprenex Zorbium Brixadi buprenorphine transdermal system Buprenorphine Sublingual C-III Buprenorphine Sublingual

Who makes Buprenorphine: manufacturers and labelers

31 companies list Buprenorphine products with the FDA. By number of product records, the largest are BioDelivery Sciences International Inc, Braeburn Inc., Bryant Ranch Prepack. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

BioDelivery Sciences International Inc 7 Braeburn Inc. 7 Bryant Ranch Prepack 7 Rhodes Pharmaceuticals LLC 7 Clinical Solutions Wholesale, LLC 6 Amneal Pharmaceuticals NY LLC 5 Aveva Drug Delivery Systems Inc. 5 Ingenus Pharmaceuticals, Llc 5 Knoa Pharma LLC 5 Remedyrepack Inc. 5 Teva Pharmaceuticals USA, Inc. 5 Advagen Pharma Ltd 4 Alvogen Inc. 4 Direct_Rx 3 Hikma Pharmaceuticals USA Inc. 3 A-S Medication Solutions 2 Actavis Pharma, Inc. 2 American Health Packaging 2 AvPAK 2 Camber Pharmaceuticals, Inc. 2 Indivior Inc. 2 Major Pharmaceuticals 2 PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma 2 Redpharm Drug 2

…and 7 more on the FDA NDC directory.

Buprenorphine drug class (RxNorm)

Buprenorphine 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.

Sources for this Buprenorphine 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 May 25, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Buprenorphine.
📈
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 after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
39
Finished products in the current FDA directory
106
Companies listing them (makers, repackagers, distributors)
31
FDA labeler codes behind them ⓘ
34
Linked representative label ⓘ
Actavis Pharma, Inc.
Linked label effective
May 25, 2026
Composite sections available
27
Linked SPL Set ID
03819118-86f6-4329-adaf-4599e7b71f46
Linked SPL Document ID
db0d877f-2f4d-4cf9-b463-6badf66037a7
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. Actavis Pharma, 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 →