Prescription medicine
Nalbuphine First approved as Nubain
Nalbuphine (Nubain) is a prescription medicine with an FDA approval on record since 1979. FDA's NDC Directory lists it from 6 generic labelers, and pharmacies paid $4.32 per mL (Nalbuphine 10 mg/mL ampul) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the nalbuphine FDA label on DailyMed (effective December 31, 2025, Hospira, Inc.); the NDA 18024 record on Drugs@FDA; every nalbuphine label on DailyMed.
Highlights of the record
FDA label of December 31, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF NALBUPHINE HYDROCHLORIDE INJECTION .
Addiction, Abuse, and Misuse Because the use of Nalbuphine Hydrochloride Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see WARNINGS ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Nalbuphine Hydrochloride Injection, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing, and titration of Nalbuphine Hydrochloride Injection are essential [see WARNINGS ]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of Nalbuphine Hydrochloride Injection and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see WARNINGS , PRECAUTIONS; Drug Interactions ].
Used for
From the label: indications and usageNalbuphine Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Forms and strengths
- 10 mg/ml
- 20 mg/ml
Injection (solution); injection.
On the market
- Earliest approval on file
- May 15, 1979 Nubain, Ph Health; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first July 2, 1986; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 6 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $4.32 per mL Nalbuphine 10 mg/mL ampul
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2012 0 Class I among all firms' recalls; latest November 21, 2012; 3 more by firms not listed as its makers
- FAERS reports
- 225 through July 30, 2026
What is nalbuphine used for?
From the label: indications and usageNalbuphine Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Nalbuphine Hydrochloride Injection can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery. […]
Conditions named in the indications of nalbuphine's FDA labels, with every medicine labeled for each:
From other nalbuphine labelsPain: INDICATIONS AND USAGE Nalbuphine Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
FDA pharmacologic class: Opioid Agonist/Antagonist.
Source: FDA drug label (Nalbuphine Hydrochloride), Hospira, Inc., effective December 31, 2025 (SPL set 6025e8d4-5083-4c3a-58a0-050e7b0b6150), via openFDA; the full label on DailyMed
Is there a generic for nalbuphine (Nubain)?
The FDA approved the first generic nalbuphine on July 2, 1986. 12 generic applications are approved; 6 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists nalbuphine from 6 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1979 earliest approval on file
- 1986 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for nalbuphine (Nubain)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $4.32 per mL (Nalbuphine 10 mg/mL ampul). The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Nalbuphine 10 mg/mL ampul (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Nalbuphine 10 mg/mL ampul | Generic | $4.32 per mL | n/a | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has nalbuphine been recalled?
The FDA's Enforcement Report lists 4 recalls naming nalbuphine since 2012: 0 Class I (the most serious), 4 Class II, 0 Class III; 0 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of nalbuphine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 27, 2022 | Class II | Sentara Infusion Services not a listed maker | Lack of sterility assurance |
| August 27, 2014 | Class II | Martin Avenue Pharmacy, Inc. not a listed maker | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. … |
| July 26, 2013 | Class II | Beacon Hill Medical Pharmacy, P.C. not a listed maker | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance |
| November 21, 2012 | Class II | Hospira, Inc. | Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the nalbuphine label say about other medicines?
The nalbuphine label names 13 other medicines in its interaction, contraindication or warning sections. The labels of 26 other medicines name nalbuphine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cyclobenzaprine | drug interactions | … serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin … |
| Gabapentin | drug interactions | … non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), and other opioids, can increase the risk of respiratory depression, profound sedation, coma, and death. |
| Linezolid | drug interactions | … monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome [see PRECAUTIONS; |
| Metaxalone | drug interactions | … neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome … |
| Methylene blue | drug interactions | … inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome [see PRECAUTIONS; |
| Mirtazapine | drug interactions | … (TCAs), triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as … |
| Nalmefene | warnings | Management of respiratory depression may include close observation, supportive measures, and use of opioid overdose reversal agents (e.g., naloxone, nalmefene), depending on the patient's clinical status [see OVERDOSAGE ]. |
| Naloxone | warnings | Management of respiratory depression may include close observation, supportive measures, and use of opioid overdose reversal agents (e.g., naloxone, nalmefene), depending on the patient's clinical status [see OVERDOSAGE ]. |
| Phenelzine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) MAOI (e.g., phenelzine, tranylcypromine, linezolid) interactions with opioids may manifest as serotonin syndrome [see PRECAUTIONS; |
| Pregabalin | drug interactions | … anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), and other opioids, can increase the risk of respiratory depression, profound sedation, coma, and death. |
| Tramadol | drug interactions | … receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous … |
| Tranylcypromine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) MAOI (e.g., phenelzine, tranylcypromine, linezolid) interactions with opioids may manifest as serotonin syndrome [see PRECAUTIONS; |
| Trazodone | drug interactions | … triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid … |
Other labels that name nalbuphine
Source: FDA drug label (Nalbuphine Hydrochloride), Hospira, Inc., effective December 31, 2025 (SPL set 6025e8d4-5083-4c3a-58a0-050e7b0b6150), via openFDA; the full label on DailyMed
What do FAERS reports show for nalbuphine?
The FDA Adverse Event Reporting System holds 225 reports that list nalbuphine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 10 are coded as a death and 79 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
How does nalbuphine compare with medicines for the same use?
1 side-by-side page set nalbuphine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to nalbuphine
- medicines labeled for the same conditions
- Other opioid agonist/antagonists
- the pharmacologic class, with prices and generics
- Nalbuphine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other