NDC 51662-1418-1 (billing 51662-1418-01)

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51662-1418-1

Product NDC 51662-1418

11-digit billing NDC 51662141801

RxCUI 904440

UNII ZU4275277R

Application # ANDA070918

SPL Set ID 96128b54-24d6-88a3-e053-2a95a90a1c9c

Established class (EPC) Opioid Agonist/Antagonist

Mechanism of action Competitive Opioid Antagonists; Partial Opioid Agonists

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2019-10-29

Route INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Dosage form INJECTION, SOLUTION

Substance NALBUPHINE HYDROCHLORIDE

TE code (Orange Book) AP · RLD · RS

Quick answers

RxCUI (RxNorm): 904440

Why two NDCs? The FDA registers this code as 51662-1418-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 51662-1418-01. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 1, 2026
RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
Medi-Span GPI (licensed)
First Databank (licensed) · refreshed Oct 1, 2026

RxNorm drug class

This medicine belongs to the Opioid Agonist/Antagonist class.

Pharmacologic class Opioid Agonist/Antagonist

Drug family (ATC) Morphinan derivatives

How it works Partial Opioid Agonists, Competitive Opioid Antagonists

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

RxClass (NLM) · catalog refreshed Oct 1, 2026

Clinical

📗 Our plain-language guide HelloPharmacist

It treats pain that is severe enough to need an opioid when other treatments aren't enough. It's also used as part of anesthesia, for pain before and after surgery, and for pain du...
Given into a vein, it starts working in 2 to 3 minutes. Given into a muscle or under the skin, it works in under 15 minutes. Pain relief usually lasts about 3 to 6 hours.
How quickly does it work and how long does it last?
Sleepiness is the most common. You might also feel sweaty or clammy, nauseated, dizzy, or have a dry mouth or headache. Tell your care team right away if your breathing slows, you...

📖 Read our full Nalbuphine Injection guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

MedlinePlus (NLM) · refreshed Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 1, 2026

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J2300	$4.287 / J2300 unit	—

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

CMS NADAC weekly file
CMS ASP pricing files · refreshed Sep 20, 2026
CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
CMS Part D plan pricing files · refreshed Sep 24, 2026
VA National Acquisition Center price file

Billing & reimbursement

FDA NDC (as labeled)51662-1418-1

11-digit billing NDC51662-1418-01

Format5-4-1 as registered → padded to 5-4-2 for billing (zero added to the package segment)

HCPCS J-codeJ2300

DescriptorInjection, nalbuphine hydrochloride, per 10 mg

Billing units / pkg20 units

How the units are derivedThis package is 10; the HCPCS unit is 10 MG, so one package = 20 billing units.

Medicare Part B spend (2026 (Q1))$1,489 · 362 claims · $4.11 per claim (all NDCs under J2300)

Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk

Where does this data come from?

The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
DMEPDAC NDC-HCPCS crosswalk
openFDA NSDE billing units · refreshed Sep 7, 2026

Packaging — all sizes for this product

Package NDC	Description	Marketing start	Marketing end	Status
51662-1418-01 You're viewing this Main listing	1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE	2019-10-29	—	Active

Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Nalbuphine Hydrochloride 20 mg/mL 00404-9766-10	Henry	1 vial	—	AP	FDA listed	—
Nalbuphine Hydrochloride 20 mg/mL 00409-1467-01	Hospira,	1 vial	—	AP	FDA listed	—
Nalbuphine Hci 20 mg/mLthis 51662-1418-01	HF	1 vial	—	AP	FDA listed	—
Nalbuphine hydrochloride 20 mg/mL 70069-0662-10	Somerset	1 vial	—	AP	FDA listed	—
Nalbuphine Hydrochloride 20 mg/mL 71872-7320-01	Medical	1 vial	—	AP	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA Orange Book · refreshed Oct 3, 2026
CMS NADAC weekly file

Availability & generic status

🏛️

2019

On the market since

Oct 2019

📍

2026

Currently FDA-listed

7 years listed

🔓

·

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

FDA Orange Book · refreshed Oct 3, 2026

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

FDA label on DailyMed · label index refreshed Oct 1, 2026
FDA openFDA NDC Directory · synced Oct 1, 2026

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerHF Acquisition Co LLC, DBA HealthFirst

Application holderHOSPIRA INC

FDA applicationANDA070918 (ANDA)

Labeler code51662

First marketedOct 2019

Product typeHuman Prescription Drug

Portfolio333 products on file

🔎 All NDCs from HF Acquisition Co LLC, DBA HealthFirst

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA openFDA NDC Directory · synced Oct 1, 2026
Drugs@FDA

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.

🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🔒 Drug Abuse and Dependence 📄 Package Label / Principal Display Panel

🚨 Boxed Warning 27 words ▾

BOXED WARNING Life-Threatening Respiratory Depression - Serious, life-threatening, or fatal respiratory depression may occur with use of Nalbuphine Hydrochloride Injection, particularly when used concomitantly ... BOXED WARNING

🎯 Indications and Usage 114 words ▾

INDICATIONS & 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. 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. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS ], reserve Nalbuphine Hydrochloride Injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] Have not been tolerated, or are not expected to be tolerated Have not provided adequate analgesia, or are not expected to provide adequate analgesia

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE & ADMINISTRATION Important Dosage and Administration Instructions Nalbuphine Hydrochloride Injection should be administered as a supplement to general anesthesia only by persons specifically trained in the use of intravenous anesthetics and management of the respiratory effects of potent opioids. Naloxone, resuscitative and intubation equipment and oxygen should be readily available. Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see WARNINGS ].

Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with Nalbuphine Hydrochloride Injection and adjust the dosage accordingly [see WARNINGS ]. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Initial Dosage The usual recommended adult dose is 10 mg for a 70 kg individual administered subcutaneously, intramuscularly, or intravenously; this dose may be repeated every 3 to 6 hours as necessary.

Dosage should be adjusted according to the severity of the pain, physical status of the patient, and other medications which the patient may be receiving [see WARNINGS ; Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants]. In nontolerant individuals, the recommended single maximum dose is 20 mg with a maximum total daily dose of 160 mg. The use of Nalbuphine Hydrochloride Injection as a supplement to balanced anesthesia requires larger doses than those recommended for analgesia.

Induction doses of nalbuphine hydrochloride range from 0.3 mg/kg to 3 mg/kg intravenously to be administered over a 10 to 15 minute period with maintenance doses of 0.25 to 0.5 mg/kg in single intravenous administrations as required. The use of Nalbuphine Hydrochloride Injection may be followed by respiratory depression which can be reversed with the opioid antagonist naloxone hydrochloride. Titration and Maintenance of Therapy Individually titrate Nalbuphine Hydrochloride Injection to a dose that provides adequate analgesia and minimizes adverse reactions.

Continually reevaluate patients receiving nalbuphine hydrochloride to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see WARNINGS ]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the nalbuphine hydrochloride dosage.

If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse events. Discontinuation of Nalbuphine Hydrochloride Injection When a patient who has been taking Nalbuphine Hydrochloride Injection regularly and may be physically dependent no longer requires therapy with Nalbuphine Hydrochloride Injection, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal.

If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue Nalbuphine Hydrochloride Injection in a physically-dependent patient [see WARNINGS , DRUG ABUSE AND DEPENDENCE ].

⛔ Contraindications 59 words ▾

CONTRAINDICATIONS Nalbuphine Hydrochloride Injection is contraindicated in patients with: Significant respiratory depression [see WARNINGS ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS ] Known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS ] Hypersensitivity to nalbuphine or to any of the other ingredients in Nalbuphine Hydrochloride Injection.

⚠️ Warnings ~3 min read ▾

WARNINGS Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient's clinical status [see OVERDOSAGE ].

Carbon dioxide (CO2) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of Nalbuphine Hydrochloride Injection, the risk is greatest during the initiation of therapy or following a dosage increase. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with and following dosage increases of Nalbuphine Hydrochloride Injection.

To reduce the risk of respiratory depression, proper dosing and titration of Nalbuphine Hydrochloride Injection is essential [see DOSAGE & ADMINISTRATION ]. Overestimating the Nalbuphine Hydrochloride Injection dosage when converting patients from another opioid product can result in a fatal overdose with the first dose. Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia.

Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper [see DOSAGE & ADMINISTRATION ]. Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Profound sedation, respiratory depression, coma, and death may result from the concomitant use of Nalbuphine Hydrochloride Injection with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol).

Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone. Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with opioid analgesics [see PRECAUTIONS; Drug Interactions].

If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response. If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response.

Follow patients closely for signs and symptoms of respiratory depression and sedation. Advise both patients and caregivers about the risks of respiratory depression and sedation when Nalbuphine Hydrochloride Injection is used with benzodiazepines or other CNS depressants (including alcohol and illicit drugs). Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined.

Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs [see PRECAUTIONS ; Drug Interactions and Information for Patients]. Life-Threa… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS The most frequent adverse reaction in 1066 patients treated in clinical studies with Nalbuphine Hydrochloride Injection was sedation 381 (36%). Less frequent reactions were: sweaty/clammy 99 (9%), nausea/vomiting 68 (6%), dizziness/vertigo 58 (5%), dry mouth 44 (4%), and headache 27 (3%). Other adverse reactions which occurred (reported incidence of 1% or less) were: CNS Effects: Nervousness, depression, restlessness, crying, euphoria, floating, hostility, unusual dreams, confusion, faintness, hallucinations, dysphoria, feeling of heaviness, numbness, tingling, unreality.

The incidence of psychotomimetic effects, such as unreality, depersonalization, delusions, dysphoria and hallucinations has been shown to be less than that which occurs with pentazocine. Cardiovascular: Hypertension, hypotension, bradycardia, tachycardia. Gastrointestinal: Cramps, dyspepsia, bitter taste.

Respiratory: Depression, dyspnea, asthma. Dermatologic: Itching, burning, urticaria. Miscellaneous: Speech difficulty, urinary urgency, blurred vision, flushing and warmth.

Allergic Reactions: Anaphylactic/anaphylactoid and other serious hypersensitivity reactions have been reported following the use of nalbuphine and may require immediate, supportive medical treatment. These reactions may include shock, respiratory distress, respiratory arrest, bradycardia, cardiac arrest, hypotension, or laryngeal edema. Some of these allergic reactions may be life-threatening.

Other allergic-type reactions reported include stridor, bronchospasm, wheezing, edema, rash, pruritus, nausea, vomiting, diaphoresis, weakness, and shakiness. Events Observed during Post-marketing Surveillance of Nalbuphine Hydrochloride Injection Due to the nature and limitations of spontaneous reporting, causality has not been established for the following adverse events received for Nalbuphine Hydrochloride Injection: abdominal pain, pyrexia, depressed level or loss of consciousness, somnolence, tremor, anxiety, pulmonary edema, agitation, seizures, and injection site reactions such as pain, swelling, redness, burning, and hot sensations.

Death has been reported from severe allergic reactions to Nalbuphine Hydrochloride Injection treatment. Fetal death has been reported where mothers received Nalbuphine Hydrochloride Injection during labor and delivery. Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

🆘 Overdosage ~1 min read ▾

OVERDOSAGE Clinical Presentation Acute overdose with Nalbuphine Hydrochloride Injection alone can be manifested by respiratory depression and dysphoria. Acute overdose with Nalbuphine Hydrochloride Injection and other opioids or CNS depressants can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death.

Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations. Treatment of Overdose In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated.

Cardiac arrest or arrhythmias will require advanced life-support techniques. The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to nalbuphine hydrochloride overdose, administer an opioid antagonist.

Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to Nalbuphine Hydrochloride Injection overdose. Because the duration of opioid reversal is expected to be less than the duration of action of nalbuphine, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product's prescribing information.

In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Effects on the Endocrine System Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date.

Nalbuphine Hydrochloride Injection is a potent analgesic. Its analgesic potency is essentially equivalent to that of morphine on a milligram basis. Receptor studies show that nalbuphine hydrochloride binds to mu, kappa, and delta receptors, but not to sigma receptors.

Nalbuphine hydrochloride is primarily a kappa agonist/partial mu antagonist analgesic. The onset of action of nalbuphine hydrochloride occurs within 2 to 3 minutes after intravenous administration, and in less than 15 minutes following subcutaneous or intramuscular injection. The plasma half-life of nalbuphine is 5 hours, and in clinical studies the duration of analgesic activity has been reported to range from 3 to 6 hours.

The opioid antagonist activity of nalbuphine hydrochloride is one-fourth as potent as nalorphine and 10 times that of pentazocine. Nalbuphine hydrochloride may produce the same degree of respiratory depression as equianalgesic doses of morphine. However, Nalbuphine Hydrochloride Injection exhibits a ceiling effect such that increases in dose greater than 30 mg do not produce further respiratory depression in the absence of other CNS active medications affecting respiration.

Nalbuphine hydrochloride by itself has potent opioid antagonist activity at doses equal to or lower than its analgesic dose. When administered following or concurrent with mµ agonist opioid analgesics (e.g., morphine, oxymorphone, fentanyl), nalbuphine hydrochloride may partially reverse or block opioid-induced respiratory depression from the mµ agonist analgesic. Nalbuphine Hydrochloride Injection may precipitate withdrawal in patients dependent on opioid drugs.

Nalbuphine Hydrochloride Injection should be used with caution in patients who have been receiving mu opioid analgesics on a regular basis.

📦 How Supplied / Storage and Handling 80 words ▾

HOW SUPPLIED NALBUPHINE HCI INJECTION is supplied in the following dosage forms. NDC 51662-1418-1 NALBUPHINE HCI INJECTION 20mg/mL 10mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Nalbuphine Hydrochloride Injection for intramuscular, subcutaneous, or intravenous use is a sterile solution available in: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from excessive light. Store in carton until contents have been used.

HOW SUPPLIED

📋 Description 181 words ▾

DESCRIPTION Nalbuphine hydrochloride is a synthetic opioid agonist-antagonist analgesic of the phenanthrene series. It is chemically related to both the widely used opioid antagonist, naloxone, and the potent opioid analgesic, oxymorphone. Chemically nalbuphine hydrochloride is 17-(cyclobutylmethyl)-4,5α-epoxymorphinan-3,6α,14-triol hydrochloride.

Nalbuphine hydrochloride molecular weight is 393.91 and is soluble in H2O (35.5 mg/mL at 25°C) and ethanol (0.8%); insoluble in CHCl3 and ether. Nalbuphine hydrochloride has pKa values of 8.71 and 9.96. The molecular formula is C21H27NO4 ∙ HCl.

The structural formula is: Nalbuphine Hydrochloride Injection is a sterile, nonpyrogenic solution of nalbuphine hydrochloride in water for injection. This product may be administered by subcutaneous, intramuscular or intravenous injection. Each milliliter (mL) contains nalbuphine hydrochloride 10 mg or 20 mg; sodium citrate, dihydrate 0.47 mg and citric acid, anhydrous 0.63 mg added as buffers and may contain sodium hydroxide and/or hydrochloric acid for pH adjustment; pH 3.7 (3.0 to 4.5).

Contains sodium chloride for tonicity adjustment. Multiple-dose vials contain 1.8 mg/mL methylparaben and 0.2 mg/mL propylparaben added as preservatives. Single-dose products contain no bacteriostat or antimicrobial agent and unused portions must be discarded.

STRUCTURE

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Impaired Renal or Hepatic Function Because nalbuphine is metabolized in the liver and excreted by the kidneys, Nalbuphine Hydrochloride Injection should be used with caution in patients with renal or liver dysfunction and administered in reduced amounts. Myocardial Infarction As with all potent analgesics, Nalbuphine Hydrochloride Injection should be used with caution in patients with myocardial infarction who have nausea or vomiting. Biliary Tract Surgery As with all opioid analgesics, Nalbuphine Hydrochloride Injection should be used with caution in patients about to undergo surgery of the biliary tract since it may cause spasm of the sphincter of Oddi.

Cardiovascular System During evaluation of Nalbuphine Hydrochloride Injection in anesthesia, a higher incidence of bradycardia has been reported in patients who did not receive atropine pre-operatively. Information for Patients Patients should be advised of the following information: Serotonin Syndrome Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop.

Instruct patients to inform their physicians if they are taking, or plan to take serotonergic medications [see PRECAUTIONS ; Drug Interactions]. Nalbuphine Hydrochloride Injection is associated with sedation and may impair mental and physical abilities required for the performance of potentially dangerous tasks such as driving a car or operating machinery. Nalbuphine Hydrochloride Injection is to be used as prescribed by a physician.

Dose or frequency should not be increased without first consulting with a physician since Nalbuphine Hydrochloride Injection may cause psychological or physical dependence. The use of Nalbuphine Hydrochloride Injection with other opioids can cause signs and symptoms of withdrawal. Abrupt discontinuation of Nalbuphine Hydrochloride Injection after prolonged usage may cause signs and symptoms of withdrawal.

Laboratory Tests Nalbuphine Hydrochloride Injection may interfere with enzymatic methods for the detection of opioids depending on the specificity/sensitivity of the test. Consult the test manufacturer for specific details. Drug Interactions Benzodiazepines and other Central Nervous System (CNS) Depressants Although Nalbuphine Hydrochloride Injection possesses opioid antagonist activity, there is evidence that in nondependent patients it will not antagonize an opioid analgesic administered just before, concurrently, or just after an injection of Nalbuphine Hydrochloride Injection.

Therefore, due to additive pharmacologic effects, the concomitant use of other opioid analgesics, benzodiazepines or other CNS depressants such as alcohol, other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, can increase the risk of respiratory depression, profound sedation, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required.

Follow patients closely for signs of respiratory depression and sedation [see WARNINGS ]. Serotonergic Drugs The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect 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 methylene blue), has resulted in serotonin syndrome [see PRECAUTION… [Excerpted — this section continues on DailyMed.]

🔒 Drug Abuse and Dependence ~3 min read ▾

DRUG ABUSE AND DEPENDENCE Abuse Nalbuphine Hydrochloride Injection contains nalbuphine, which can be abused and is subject to misuse, addiction, and criminal diversion [see WARNINGS ]. All patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects.

Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. "Drug-seeking" behavior is very common in persons with substance use disorders. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated "loss" of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating health care provider(s). "Doctor shopping" (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction.

Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. Abuse and addiction are separate and distinct from physical dependence and tolerance. Health care providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts.

In addition, abuse of opioids can occur in the absence of true addiction. Nalbuphine Hydrochloride Injection, like other opioids, can be diverted for non-medical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. Risks Specific to Abuse of Nalbuphine Hydrochloride Abuse of Nalbuphine Hydrochloride Injection poses a risk of overdose and death. The risk is increased with concurrent abuse of Nalbuphine Hydrochloride Injection with alcohol and other central nervous system depressants.

Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. Dependence Both tolerance and physical dependence opioid therapy can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors).

Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. Physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (pentazocine, butorphanol, nalbuphine), or partial agonists (buprenorphine).

Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. Nalbuphine Hydrochloride Injection should not be abruptly discontinued [see DOSAGE & ADMINISTRATION ]. If Nalbuphine Hydrochloride Injection is abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur.

Some or all of the following can characteri… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 26 words ▾

PRINCIPAL DISPLAY PANEL - VIAL LABEL VIAL LABELING

PRINCIPAL DISPLAY PANEL - CARTON LABELING CARTON LABELING

PRINCIPAL DISPLAY PANEL - SERIALIZED CARTON LABELING SERIALIZED CARTON LABELING

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

serotonergic: Acting on serotonin, a chemical messenger involved in mood, sleep, and digestion.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

abuse: Using a medicine in a way it was not meant to be used, such as taking more than prescribed to feel a high.

adrenal insufficiency: A condition where the adrenal glands do not make enough of certain needed hormones, such as cortisol, a stress hormone.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

agonist: A substance that switches on a specific target in the body to produce an effect, the way a key turns a lock.

amenorrhea: The absence of monthly menstrual periods.

antagonist: A substance that blocks a target in the body so a natural signal or another medicine cannot produce its usual effect.

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

apnea: A pause or temporary stop in breathing.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

cardiac arrest: A sudden stop of the heart's pumping that cuts off blood flow to the body, which is a medical emergency.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

depression: A lasting low mood with loss of interest that affects everyday life.

diaphoresis: Heavy or excessive sweating.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Abuse and Dependence: A label section describing a medicine's potential to be misused and to cause the body to rely on it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

dysphoria: A general feeling of unease, dissatisfaction, or unhappiness.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

edema: Swelling caused by extra fluid trapped in the body's tissues.

erectile dysfunction: Trouble getting or keeping an erection.

euphoria: An intense feeling of happiness or well-being that is stronger than a normal good mood.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

hypoxemia: A lower-than-normal level of oxygen in the blood.

hypoxia: A condition in which the body's tissues do not get enough oxygen.

ileus: A slowdown or stop in the normal movement of the intestines, so food and waste do not pass through.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

intramuscular: An injection given deep into a muscle; often written as IM.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

misuse: Using a medicine differently from how it was prescribed or directed, whether on purpose or by mistake.

mydriasis: Widening of the pupil, the dark center of the eye.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

parenteral: Given by injection or drip into the body rather than swallowed by mouth.

physical dependence: When the body adapts to a medicine over time, so stopping it suddenly causes uncomfortable symptoms.

potency: How much of a medicine is needed to produce a given effect; a more potent medicine works at a smaller dose.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

pruritus: Itching of the skin.

pulmonary edema: A buildup of fluid in the lungs' air sacs that makes it hard to breathe.

pyrexia: A raised body temperature; a fever.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

respiratory depression: Breathing that becomes too slow or too shallow to move enough air, so the body may not get enough oxygen.

restlessness: An inability to stay calm or still, with a constant feeling of needing to move.

sedation: A calm, sleepy, slowed-down state caused by a medicine that relaxes the brain and body.

serotonin syndrome: A potentially dangerous reaction from too much of the brain chemical serotonin, causing agitation, fast heartbeat, sweating, and muscle twitching.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

stridor: A harsh, high-pitched sound heard when breathing in, caused by narrowing of the upper airway.

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

taper: Gradually lowering a dose in steps before stopping, rather than quitting all at once.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

tolerance: When the body gets used to a medicine over time, so a larger dose is needed to get the same effect.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

urticaria: Raised, itchy welts on the skin, commonly called hives.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

wheezing: A high-pitched whistling sound made while breathing, usually when the airways are narrowed.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	— Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured)	— Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	✓ Available
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by HF Acquisition Co LLC, DBA HealthFirst. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

HF Acquisition Co LLC, DBA HealthFirst is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

Does this product have a billing J-code?

Yes — this NDC cross-references HCPCS code J2300 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

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NALBUPHINE HCI 20 mg/mL Injection, Solution — NDC 51662-1418-1 (Billing 51662-1418-01)

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