Buprenorphine is a partial opioid agonist sold in the U.S. under 7 brand and generic names, for heroin dependence and pain. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Buprenorphine Hydrochloride (application ANDA078633). Other buprenorphine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Prescription use of this product is limited under the Drug Addiction Treatment Act. ( 2.1 ) Administer buprenorphine sublingual tablet sublingually as a single daily dose. ( 2.2 ) To avoid precipitating withdrawal, induction with buprenorphine sublingual tablet 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. ( 2.3 ) Administer buprenorphine sublingual tablets as directed in the Full Prescribing Information ( 2.3 , 2.4 ). 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 Drug Addiction Treatment Act Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription. 2.2 Important Dosage…
The following serious adverse reactions are described elsewhere in the labeling: Addiction, Abuse, and Misuse [see Warnings and Precautions ( 5.1 )] Respiratory and CNS Depression [see Warnings and Precautions ( 5.2 )] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions ( 5.5 )] Adrenal Insufficiency [see Warnings and Precautions ( 5.6 )] Opioid Withdrawal [see Warnings and Precautions ( 5.7 , 5.10 )] Hepatitis, Hepatic Events [see Warnings and Precautions ( 5.8 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.9 )] Orthostatic Hypotension [see Warnings and Precautions ( 5.14 )] Elevation of Cerebrospinal Fluid Pressure [see Warnings and Precautions ( 5.15 )] Elevation of Intracholedochal Pressure [see Warnings and Precautions ( 5.16 )] Adverse events commonly observed with administration of Buprenorphine Sublingual Tablets are oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Injectable | Generic | $681 | View → | |
| 2 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| 8;6 | 8.6 mg / 2.1 mg | white | diamond | — |
| 11;4 | 11.4 mg / 2.9 mg | white | capsule | — |
| 5;7 | 5.7 mg / 1.4 mg | white | round | — |
| 7 | 0.7 mg / 0.18 mg | white | oval | — |
| 2;9 | 2.9 mg / 0.71 mg | white | semi-circle | — |
| 1;4 | 1.4 mg / 0.36 mg |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Buprenorphine HCl
Crystallization; identified as Buprenorphine free base
Par Health USA, LLC · Jun 12, 2026
Buprenorphine Hydrochloride
Crystallization; identified as Buprenorphine free base
ENDO USA, Inc. · Mar 13, 2026
Buprenorphine Hydrochloride Injection
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Pfizer Inc. · May 20, 2024
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Buprenorphine Sublingual Tablets is contraindicated in patients with a history of hypersensitivity to buprenorphine, as serious adverse reactions, including anaphylactic shock, have been reported [see Warnings and Precautions ( 5.9 )] . Hypersensitivity to buprenorphine. ( 4 )
Table 3 includes clinically significant drug interactions with Buprenorphine Sublingual Tablets. Table 3. Clinically Significant 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. 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 )]. Examples: Alcohol, non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids. 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…
| Not yet rated |
| Prescription |
| Film |
| Generic |
| $681 |
| View → |
| 3 | Not yet rated | Prescription | Injectable | Generic | $681 | View → |
| 4 | Not yet rated | Prescription | Injectable | Generic | $681 | View → |
| 5 | Not yet rated | Prescription | Implant | Generic | $681 | View → |
| 6 | Not yet rated | Prescription | Solution | Generic | $681 | View → |
| 7 | Not yet rated | Prescription | Tablet | Generic | $681 | View → |
| white |
| triangle |
| — |
| 54;375 | 8 mg / 2 mg | orange | round | — |
|---|
| 54;122 | 2 mg / 0.5 mg | orange | round | — |
|---|
| BN;2 | 2 mg / 0.5 mg | white | round | — |
|---|
| BN;8 | 8 mg / 2 mg | white | round | — |
|---|
| 8 | 8 mg / 2 mg | pink | hexagon (6 sided) | — |
|---|
| RP;n2 | 2 mg / 0.5 mg | orange | round | — |
|---|