FDA-filed SPL labeling · retrieved through openFDA

Buprenorphine

Buprenorphine is a prescription sublingual (under-the-tongue) tablet used to treat opioid dependence as part of a full recovery program.

Brand names ButransSimbadolBelbucaSublocadeBuprenex +5 more
Drug class ⓘ Partial Opioid Agonists
Rx Schedule CIII Forms 4 Routes Sublingual · Transdermal · Buccal · Subcutaneous +2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 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 →

At a glance
Linked label effectiveMay 25, 2026
Clinical labels in scope ⓘ39
AvailabilityRx
Earliest approval/marketing year ⓘ1981
FDA-listed product records ⓘ310
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 16, 2026 🚨Recall on record · 3
Other forms & routes:
Transdermal
⭐ Buprenorphine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Buprenorphine is an effective, evidence-based treatment for opioid dependence when used exactly as prescribed alongside counseling and support. Its biggest danger is breathing problems — especially when mixed with alcohol, benzodiazepines, or other sedatives — so keeping a naloxone rescue kit nearby is a smart safety step. Always follow your prescriber's plan, never share this medication, and store it safely away from children.
How we write & review this content — our editorial policy →

📖 Buprenorphine: Patient Information Guide

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

🎯What it's used for▾

Buprenorphine sublingual tablets are used to treat opioid dependence. Here's where it fits in treatment:

  • Induction phase: The first days of treatment when opioids are being stopped — buprenorphine is preferred for this stage
  • Opioid dependence management: Reducing cravings and easing withdrawal as part of a longer-term recovery plan
  • Part of a full program: Always used alongside counseling and psychosocial support, not as a standalone fix
⚙️How it works▾

Buprenorphine is a partial opioid agonist — it attaches to the mu-opioid receptors in the brain (the same ones targeted by heroin, oxycodone, and other opioids) but only partially activates them. This partial activation is enough to reduce cravings and prevent withdrawal symptoms, but it doesn't produce the intense high of a full opioid. It also acts as a blocker at kappa-opioid receptors, which adds to its stabilizing effect.

Because it's a partial agonist, it has a so-called ceiling effect — above a certain level, taking more doesn't increase the opioid effect much, which lowers (but does not eliminate) the risk of dangerous overdose compared to full opioids. High-level brain receptor studies have shown it can block the effects of other opioids when adequate levels are maintained in the body.

💊How it's taken▾

Buprenorphine sublingual tablets are placed under the tongue once daily and allowed to fully dissolve. Do not chew, cut, or swallow the tablet — the medication only works properly when absorbed through the lining of the mouth.

  • Always take it as directed by your prescriber — do not adjust your own dose
  • Induction (starting treatment) should only begin when clear signs of withdrawal are present, to avoid triggering sudden severe withdrawal
  • When stopping, the dose must be tapered gradually — never stop abruptly
  • Your prescriber will transition you to a buprenorphine/naloxone combination product after the initial induction phase in most cases
🤒Side effects — in detail▾

The most commonly reported side effects include:

  • Headache
  • Nausea or vomiting
  • Constipation
  • Sweating more than usual
  • Insomnia (trouble sleeping)
  • Numbness, pain, or redness in or around the mouth
  • Swelling in the legs or feet (peripheral edema)
  • Withdrawal-like symptoms, especially early in treatment

Seek immediate medical attention for serious reactions: slow or stopped breathing, extreme drowsiness or unresponsiveness, signs of liver problems (yellowing skin or eyes), or any signs of a severe allergic reaction such as throat swelling or difficulty breathing.

⚠️Warnings & precautions▾
  • Breathing problems (respiratory depression): The most dangerous risk — combining buprenorphine with alcohol, benzodiazepines, or other sedating drugs can cause breathing to slow or stop entirely. Deaths have occurred. Keep naloxone on hand.
  • Children must never access this medication: Even a small amount can cause fatal breathing suppression in a child. Store it locked and out of sight.
  • Neonatal opioid withdrawal syndrome: Babies born to people who used buprenorphine during pregnancy may experience withdrawal after birth. This is an expected and treatable outcome — but must be planned for with your care team.
  • Liver problems: Buprenorphine can affect liver function. Liver tests should be done before starting and monitored during treatment. Report any yellowing of eyes or skin, unusual fatigue, or stomach pain right away.
  • Misuse and diversion: This is a controlled substance. Taking more than prescribed or sharing it is dangerous and illegal.
  • Risk in opioid-naïve patients: This medication is not a painkiller for everyday use. It should never be taken by someone without opioid dependence — it has caused deaths in opioid-naïve individuals.
🔀What it interacts with▾

Buprenorphine has several important interactions that can be life-threatening or affect how well it works:

  • Benzodiazepines and sedatives (e.g., Xanax, Valium, Klonopin, sleep aids) — greatly increases risk of fatal breathing problems and deep sedation
  • Alcohol — acts like a sedative and sharply raises overdose risk
  • Other opioids — compounding sedation and respiratory depression
  • Gabapentin or pregabalin — increases risk of sedation and breathing suppression
  • Antipsychotics, muscle relaxants, general anesthetics — all increase sedation risk
  • CYP3A4 inhibitors (certain antifungals like ketoconazole, some HIV medications, some antibiotics) — raise buprenorphine blood levels, potentially causing overdose-like effects
  • CYP3A4 inducers (such as rifampin or certain seizure medications) — lower buprenorphine levels, which can trigger withdrawal

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

📋Before taking it▾
  • Allergy to buprenorphine: Do not take this medication — serious allergic reactions including anaphylactic shock have been reported
  • Liver disease: Tell your doctor — severe liver impairment requires close monitoring and possible dose adjustment
  • Pregnancy: Discuss risks with your provider; prolonged use can cause neonatal opioid withdrawal syndrome in the newborn
  • Breastfeeding: Buprenorphine passes into breast milk — weigh the risks with your doctor before breastfeeding
  • Older adults: Higher risk of sedation and breathing problems — more frequent monitoring is recommended
  • Opioid-naïve individuals: This medication is not appropriate and can be fatal in people without opioid dependence
  • Children: Keep completely away — accidental exposure can be deadly
🚑If you take too much▾

Signs of buprenorphine overdose include pinpoint pupils, severe drowsiness, low blood pressure, slow or stopped breathing, and loss of consciousness. If you suspect an overdose, call 911 immediately. An opioid overdose reversal agent (like naloxone) can help, but higher-than-normal doses and repeated administration may be needed because buprenorphine is long-acting. Medical monitoring must continue long enough to ensure the overdose effects have fully resolved.

📡Pharmacodynamics — effects in the body▾

Buprenorphine acts on opioid receptors throughout the body. In the brain, it can suppress the urge to use opioids and blunt the reward of other opioids — studies show it can occupy 75–92% of mu-opioid receptors in the brain, helping to block the effects of other opioids like hydromorphone. In the body, it slows movement through the digestive tract (causing constipation), can lower blood pressure — especially when standing up quickly — and causes the pupils to constrict (become very small). It also suppresses breathing at the brain level, which is why respiratory depression is the most serious safety concern.

🔬Pharmacokinetics — how your body processes it▾

When taken as a sublingual tablet, buprenorphine is absorbed through the lining of the mouth. The tablet must be allowed to fully dissolve under the tongue — swallowing it reduces how much the body absorbs. Buprenorphine is a long-acting medication, which means it stays active in the body for an extended period; this is why once-daily dosing works, but also why overdose monitoring must continue for a prolonged time. The liver plays a central role in processing the drug, which is why people with severe liver problems need closer monitoring and possible dose adjustments.

📦How to store it▾

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

🩺 Pharmacist Counseling Corner

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

What exactly is buprenorphine supposed to do for me? ▾
Buprenorphine helps your body and brain stabilize after opioid dependence. It works by partially activating the same receptors in the brain that opioids like heroin or prescription painkillers affect — enough to ease cravings and prevent withdrawal symptoms, but without producing the intense high of a full opioid. Think of it as taking the edge off so you can focus on recovery. It works best when combined with counseling and support.
How do I take this tablet — do I just swallow it? ▾
No — and this part really matters. You place the tablet under your tongue and let it fully dissolve there. Don't chew it, cut it, or swallow it whole. The medication is designed to be absorbed through the lining of your mouth, and swallowing it means your body won't get the full benefit. Take it once a day at around the same time each day, as your prescriber instructs.
Can I drink alcohol while I'm taking this? ▾
You should avoid alcohol entirely while taking buprenorphine. Alcohol acts as a sedative and, combined with buprenorphine, it can slow your breathing to dangerous levels — this combination has caused deaths. The same warning applies to sleeping pills, anti-anxiety medications like Xanax or Valium, and other sedating drugs. Always tell every doctor or pharmacist what you're taking so they can check for these combinations.
What side effects should I expect, and which ones mean I need to call my doctor? ▾
Common side effects include headache, nausea, constipation, sweating, trouble sleeping, and some numbness or soreness in your mouth where the tablet dissolves. These are usually manageable. However, call for emergency help immediately if you notice very slow or difficult breathing, extreme drowsiness you can't shake, yellowing of your skin or eyes, or swelling in your throat — those are signs something serious is happening and can't wait.
I'm pregnant — is it safe for me to keep taking buprenorphine? ▾
This is a conversation you really need to have with your prescriber, and soon. Using buprenorphine during pregnancy can cause withdrawal symptoms in your newborn after birth — called neonatal opioid withdrawal syndrome — but this is a known, treatable outcome that your care team can plan for. The risks of untreated opioid dependence during pregnancy are also serious. Your doctor can help you weigh what's safest for you and your baby and set up the right support.
What happens if I miss a dose or want to stop taking it? ▾
If you miss a dose, take it as soon as you remember — but check with your prescriber for specific guidance, since they know your situation best. The important thing is never to stop buprenorphine suddenly on your own. Because your body adapts to having it, stopping abruptly can trigger withdrawal symptoms. Your prescriber will help you taper the dose down slowly and safely when the time is right to stop.
Is Buprenorphine available over the counter? ▾
Buprenorphine is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
Is Buprenorphine a controlled substance? ▾
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? ▾
Buprenorphine has been available in the United States since at least 1981, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Buprenorphine? ▾
Buprenorphine is supplied by 64 manufacturers listed in the FDA NDC Directory, including BioDelivery Sciences International Inc, Teva Pharmaceuticals USA, Inc., Bryant Ranch Prepack.

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

🧰 Keep exploring

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

💊 How Buprenorphine 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.

Sublingual tablet

Under the tongue
Brands Buprenorphine Sublingual Buprenorphine Sublingual C-III
Available strengths 4 strengths
2 mg 4 mg 8 mg 12 mg
119 FDA-listed product records ⓘ

📊 Buprenorphine across the U.S. market

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.

4
Dose forms ⓘ
64
Manufacturers
11
Brand names
310
FDA-listed product records ⓘ
1981
First marketed ⓘ

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

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 Inc8%
Teva Pharmaceuticals USA, Inc.7%
Bryant Ranch Prepack6%
Amneal Pharmaceuticals NY LLC5%
Rhodes Pharmaceuticals L.P.5%
Remedyrepack Inc.5%
Other makers64%

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

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 1,594 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 1,594
#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 200 of 310 products — FDA National Drug Code Directory. See every product, package size and price: browse all 310 Buprenorphine NDCs →

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.

🏷️ Sold under these brand names

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

🏭 Manufacturers & labelers

BioDelivery Sciences International Inc 21 Teva Pharmaceuticals USA, Inc. 20 Bryant Ranch Prepack 17 Amneal Pharmaceuticals NY LLC 15 Rhodes Pharmaceuticals L.P. 14 Remedyrepack Inc. 14 Braeburn Inc. 14 Alvogen Inc. 12 Ingenus Pharmaceuticals, Llc 10 Clinical Solutions Wholesale, LLC 10 Purdue Pharma LP 10 Indivior Inc. 9 Sun Pharmaceutical Industries, Inc. 9 SpecGx LLC 9 Actavis Pharma, Inc. 8 Hikma Pharmaceuticals USA Inc. 8 Rhodes Pharmaceuticals LLC 7 Major Pharmaceuticals 6 Advagen Pharma Ltd 6 Aveva Drug Delivery Systems Inc. 5 A-S Medication Solutions 5 Knoa Pharma LLC 5 PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma 4 American Health Packaging 4

…and 16 more on the FDA NDC directory.

RxNorm drug class

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.

🔬 Where this comes from

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

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective 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
NDC products indexed
310
Distinct labelers/manufacturers represented
64
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 we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 39 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

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

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