NALOXONE HCI .4 mg/mL Injection, Solution, 1 mL
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Opioid Antagonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Naloxone injection is used along with emergency medical treatment to reverse the life-threatening effects of a known or suspected opiate (narcotic) overdose. Naloxone injection is also used after surgery to reverse the effects of opiates given during surgery. Naloxone injection is given to newborns to decrease the effects of opiates received by the pregnant mother prior to delivery. Naloxone injection is in a class of medications called opiate antagonists. It works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood.
Read the full MedlinePlus article ↗- Naloxone is an emergency medicine that rapidly reverses the effects of an opioid overdose — things like very slow or stopped breathing, extreme drowsiness, or unconsciousness. You...
- What exactly does naloxone do, and when should I use it?
- Give one spray into one nostril. The device is ready to use — no assembly needed for most products like Narcan or Kloxxado. If the person doesn't improve within 2 to 3 minutes, giv...
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Patient education
Supplement & herbal interactions
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🧪 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.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
3 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 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 · Q2 2026 | $5.86 | $5.86 / 1 ml |
| Medicare Part B allowsASP · J2312 | $0.069 / J2312 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Naloxone Hydrochloride .4 mg/mL 00409-1215-01 | Hospira, | 10 vials | $4.015 | AP | Availability likely | — |
| naloxone hydrochloride .4 mg/mL 36000-0308-10 | Baxter | 10 vials | $4.015 | AP | Availability likely | — |
| Naloxone Hydrochloride .4 mg/mL 67457-0292-02 | Mylan | 10 vials | $4.015 | AP | Discontinued | — |
| Naloxone Hydrochloride .4 mg/mL 70069-0071-10 | Somerset | 10 vials | $4.015 | AP | Availability likely | — |
| naloxone hydrochloride .4 mg/mL 70756-0658-10 | Lifestar | 10 vials | $4.015 | AP | Availability likely | — |
| naloxone hydrochloride .4 mg/mL 70756-0850-10 | Lifestar | 10 vials | $4.015 | AP | Availability likely | — |
| naloxone hydrochloride .4 mg/mL 72603-0590-10 | NorthStar | 10 vials | $4.015 | AP | Availability likely | — |
| Naloxone Hydrochloride .4 mg/mL 55150-0327-10 | Eugia | 10 vials | $6.488 | — | FDA listed | — |
| Naloxone Hydrochloride .4 mg/mL 00404-9773-01 | Henry | 1 vial | — | AP | FDA listed | — |
| Naloxone Hydrochloride .4 mg/mL 00404-9923-01 | Henry | 1 vial | — | AP | Discontinued | — |
| Naloxone Hydrochloride .4 mg/mL 00641-6132-25 | Hikma | 25 vials | — | AP | FDA listed | — |
| Naloxone Hydrochloride .4 mg/mL 00641-6260-25 | Hikma | 25 vials | — | AP | FDA listed | — |
| Naloxone Hydrochloride .4 mg/mL 50090-5427-00 | A-S | 10 vials | — | AP | FDA listed | — |
| Naloxone Hydrochloride .4 mg/mL 50090-6491-00 | A-S | 10 vials | — | AP | FDA listed | — |
| Naloxone Hci .4 mg/mLthis 51662-1242-01 | HF | 1 ml | — | AP | FDA listed | — |
| Naloxone Hydrochloride .4 mg/mL 51662-1544-01 | HF | 1 ml | — | — | FDA listed | — |
| Naloxone Hydrochloride .4 mg/mL 51662-1671-03 | HF | 25 vials | — | AP | FDA listed | — |
| Naloxone Hydrochloride .4 mg/mL 70385-2033-01 | Sina | 1 vial | — | AP | FDA listed | — |
| Naloxone Hydrochloride .4 mg/mL 71872-7009-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Naloxone Hydrochloride .4 mg/mL 71872-7198-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Naloxone Hydrochloride .4 mg/mL 71872-7219-01 | Medical | 1 vial | — | — | FDA listed | — |
| naloxone hydrochloride .4 mg/mL 71872-7297-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Naloxone Hydrochloride .4 mg/mL 84549-0071-10 | ProPharma | 1 ml | — | AP | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 51662-1242-01 You're viewing this | 1 mL in 1 VIAL (51662-1242-1) | 2018-08-18 | Active |
| 51662-1242-03 | 50 POUCH in 1 CASE (51662-1242-3) / 1 mL in 1 POUCH (51662-1242-2) | 2020-06-15 | Active |
Pack size FAQ
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🧭 About this NDC listing & data coverage
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) | ✓ 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. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATION & USAGE Naloxone Hydrochloride Injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. Naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock ( see CLINICAL PHARMACOLOGY, Adjunctive Use in Septic Shock ).
⏱️ Dosage and Administration ▾
DOSAGE & ADMINISTRATION Naloxone Hydrochloride Injection, USP may be administered intravenously, intramuscularly, or subcutaneously. The most rapid onset of action is achieved by intravenous administration and it is recommended in emergency situations. Since the duration of action of some opioids may exceed that of naloxone, the patient should be kept under continued surveillance.
Repeated doses of naloxone should be administered, as necessary. Intravenous Infusion: Naloxone Hydrochloride Injection, USP may be diluted for intravenous infusion in 0.9% sodium chloride injection or 5% dextrose injection. The addition of 2 mg of naloxone hydrochloride in 500 mL of either solution provides a concentration of 0.004 mg/mL.
Mixtures should be used within 24 hours. After 24 hours, the remaining unused solution must be discarded. The rate of administration should be titrated in accordance with the patient's response.
Naloxone Hydrochloride Injection, USP should not be mixed with preparations containing bisulfite, metabisulfite, long-chain or high molecular weight anions, or any solution having an alkaline pH. No drug or chemical agent should be added to Naloxone Hydrochloride Injection, USP unless its effect on the chemical and physical stability of the solution has first been established. Usage in Adults: Opioid Overdose—Known or Suspected: An initial dose of 0.4 mg to 2 mg of naloxone hydrochloride may be administered intravenously.
If the desired degree of counteraction and improvement in respiratory functions is not obtained, it may be repeated at 2 to 3 minute intervals. If no response is observed after 10 mg of naloxone hydrochloride have been administered, the diagnosis of opioid induced or partial opioid induced toxicity should be questioned. Intramuscular or subcutaneous administration may be necessary if the intravenous route is not available.
Postoperative Opioid Depression: For the partial reversal of opioid depression following the use of opioids during surgery, smaller doses of naloxone hydrochloride are usually sufficient. The dose of naloxone should be titrated according to the patient's response. For the initial reversal of respiratory depression, naloxone hydrochloride should be injected in increments of 0.1 to 0.2 mg intravenously at two to three minute intervals to the desired degree of reversal, i.e., adequate ventilation and alertness without significant pain or discomfort.
Larger than necessary dosage of naloxone may result in significant reversal of analgesia and increase in blood pressure. Similarly, too rapid reversal may induce nausea, vomiting, sweating or circulatory stress. Repeat doses of naloxone may be required within one to two hour intervals depending upon the amount, type (i.e., short or long acting) and time interval since last administration of opioid.
Supplemental intramuscular doses have been shown to produce a longer lasting effect. Septic Shock: The optimal dosage of Naloxone or duration of therapy for the treatment of hypotension in septic shock patients has not been established (see CLINICAL PHARMACOLOGY ). Usage in Pediatric Population: Opioid Overdose—Known or Suspected: The usual initial dose in pediatric patients is 0.01 mg/kg body weight given I.V.
If this dose does not result in the desired degree of clinical improvement, a subsequent dose of 0.1 mg/kg body weight may be administered. If an I.V. route of administration is not available, Naloxone Hydrochloride may be administered I.M. or S.C. in divided doses. If necessary, Naloxone Hydrochloride Injection, USP can be diluted with sterile water for injection.
Postoperative Opioid Depression: Follow the recommendations and cautions under Adult Postoperative Depression. For the initial reversal of respiratory depression, naloxone hydrochloride should be injected in increments of 0.005 mg to 0.01 mg intravenously at two to three minute intervals to the desired degree of reversal. Usage in Neonates When using naloxone hydrochloride injection…
⛔ Contraindications ▾
CONTRAINDICATIONS Naloxone hydrochloride injection is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients contained in the formulation.
⚠️ Warnings ▾
WARNINGS Drug Dependence Naloxone hydrochloride injection should be administered cautiously to persons, including newborns of mothers, who are known or suspected to be physically dependent on opioids. In such cases, an abrupt and complete reversal of opioid effects may precipitate an acute withdrawal syndrome. The signs and symptoms of opioid withdrawal in a patient physically dependent on opioids may include but are not limited to, the following: body aches, diarrhea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.
In the neonate, opioid withdrawal may also include: convulsions, excessive crying, and hyperactive reflexes. Repeat Administration The patient who has satisfactorily responded to naloxone should be kept under continued surveillance and repeated doses of naloxone should be administered, as necessary, since the duration of action of some opioids may exceed that of naloxone. Respiratory Depression Due to Other Drugs Naloxone is not effective against respiratory depression due to non-opioid drugs and in the management of acute toxicity caused by levopropoxyphene.
Reversal of respiratory depression by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete or require higher doses of naloxone. If an incomplete response occurs, respirations should be mechanically assisted as clinically indicated.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Postoperative The following adverse events have been associated with the use of naloxone hydrochloride injection in postoperative patients: hypotension, hypertension, ventricular tachycardia and fibrillation, dyspnea, pulmonary edema, and cardiac arrest. Death, coma, and encephalopathy have been reported as sequelae of these events. Excessive doses of naloxone in postoperative patients may result in significant reversal of analgesia and may cause agitation (see PRECAUTIONS and DOSAGE AND ADMINISTRATION; Usage in Adults-Postoperative Opioid Depression).
Opioid Depression Abrupt reversal of opioid depression may result in nausea, vomiting, sweating, tachycardia, increased blood pressure, tremulousness, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest which may result in death (see PRECAUTIONS ). Opioid Dependence Abrupt reversal of opioid effects in persons who are physically dependent on opioids may precipitate an acute withdrawal syndrome which may include, but not limited to the following signs and symptoms: body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, and tachycardia.
In the neonate, opioid withdrawal may also include: convulsions, excessive crying, and hyperactive reflexes (See WARNINGS ). Adverse events associated with the postoperative use of naloxone hydrochloride injection are listed by organ system and in decreasing order of frequency as follows: Cardiac Disorders: pulmonary edema, cardiac arrest or failure, tachycardia, ventricular fibrillation, and ventricular tachycardia. Death, coma, and encephalopathy have been reported as sequelae of these events.
Gastrointestinal Disorders: vomiting, nausea Nervous System Disorders: convulsions, paraesthesia, grand mal convulsion Psychiatric Disorders: agitation, hallucination, tremulousness Respiratory, Thoracic, and Mediastinal Disorders: dyspnea, respiratory depression, hypoxia Skin and Subcutaneous Tissue Disorders: nonspecific injection site reactions, sweating Vascular Disorders: hypertension, hypotension, hot flashes, or flushing See also PRECAUTIONS and DOSAGE AND ADMINISTRATION; Usage in Adults, Postoperative Opioid Depression
🆘 Overdosage ▾
OVERDOSAGE There is limited clinical experience with naloxone hydrochloride injection overdosage in humans. Adult Patients In one small study, volunteers who received 24 mg/70 kg did not demonstrate toxicity. In another study, 36 patients with acute stroke received a loading dose of 4 mg/kg (10 mg/m2/min) of naloxone hydrochloride injection followed immediately by 2 mg/kg/hr for 24 hours.
Twenty-three patients experienced adverse events associated with naloxone use, and naloxone was discontinued in seven patients because of adverse effects. The most serious adverse events were: seizures (2 patients), severe hypertension (1), and hypotension and/or bradycardia (3). At doses of 2 mg/kg in normal subjects, cognitive impairment and behavioral symptoms, including irritability, anxiety, tension, suspiciousness, sadness, difficulty concentrating, and lack of appetite have been reported.
In addition, somatic symptoms, including dizziness, heaviness, sweating, nausea, and stomachaches were also reported. Although complete information is not available, behavioral symptoms were reported to often persist for 2 to 3 days. Pediatric Patients Up to 11 doses of 0.2 mg naloxone (2.2 mg) have been administered to children following overdose of diphenoxylate hydrochloride with atropine sulfate.
Pediatric reports include a 2½ year-old child who inadvertently received a dose of 20 mg naloxone for treatment of respiratory depression following overdose with diphenoxylate hydrochloride with atropine sulfate. The child responded well and recovered without adverse sequelae. There is also a report of a 4½ year-old child who received 11 doses during a 12-hour period, with no adverse sequelae.
Patient Management Patients who experience a naloxone overdose should be treated symptomatically in a closely supervised environment. Physicians should contact a poison control center for the most up-to-date patient management information.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Complete or Partial Reversal of Opioid Depression Naloxone prevents or reverses the effects of opioids including respiratory depression, sedation and hypotension. Also, Naloxone can reverse the psychotomimetic and dysphoric effects of agonist-antagonists, such as pentazocine. Naloxone is an essentially pure opioid antagonist, i.e., it does not possess the "agonistic" or morphine-like properties characteristic of other opioid antagonists.
When administered in usual doses and in the absence of opioids or agonistic effects of other opioid antagonists, it exhibits essentially no pharmacologic activity. Naloxone has not been shown to produce tolerance or cause physical or psychological dependence. In the presence of physical dependence on opioids, naloxone will produce withdrawal symptoms.
However, in the presence of opioid dependence, opiate withdrawal symptoms may appear within minutes of naloxone administration and will subside in about 2 hours. The severity and duration of the withdrawal syndrome are related to the dose of naloxone and to the degree and type of opioid dependence. While the mechanism of action of naloxone is not fully understood, in vitro evidence suggests that naloxone antagonizes opioid effects by competing for the mu, kappa, and sigma opiate receptor sites in the CNS, with the greatest affinity for the mu receptor.
When naloxone hydrochloride is administered intravenously, the onset of action is generally apparent within two minutes; the onset of action is slightly less rapid when it is administered subcutaneously or intramuscularly. The duration of action is dependent upon the dose and route of administration of naloxone hydrochloride. Intramuscular administration produces a more prolonged effect than intravenous administration.
Since the duration of action of naloxone may be shorter than that of some opiates, the effects of the opiate may return as the effects of naloxone dissipates. The requirement for repeat doses of naloxone, however, will also be dependent upon the amount, type and route of administration of the opioid being antagonized. Adjunctive Use in Septic Shock Naloxone has been shown in some cases of septic shock to produce a rise in blood pressure that may last up to several hours; however this pressor response has not been demonstrated to improve patient survival.
In some studies, treatment with naloxone in the setting of septic shock has been associated with adverse effects, including agitation, nausea and vomiting, pulmonary edema, hypotension, cardiac arrhythmias, and seizures. The decision to use naloxone in septic shock should be exercised with caution, particularly in patients who may have underlying pain or have previously received opioid therapy and may have developed opioid tolerance. Because of the limited number of patients who have been treated, optimal dosage and treatment regimens have not been established.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED NALOXONE HCI INJECTION, USP is supplied in the following dosage forms. NDC 51662-1242-1 NALOXONE HCI INJECTION, USP 0.4mg/mL 1mL VIAL NDC 51662-1242-2 Pouch containing a single NALOXONE HCI INJECTION, USP 0.4mg/mL 1mL VIAL NDC 51662-1242-3 Case of 50 pouches of NALOXONE HCI INJECTION, USP 0.4mg/mL 1mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Naloxone Hydrochloride Injection, USP is supplied in the following: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light.
Printed in USA Hospira, Inc., Lake Forest, IL 60045 USA LAB-1216-1.0 Revised: 01/2018 HOW SUPPLIED LOGO
📋 Description ▾
DESCRIPTION Naloxone Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of naloxone hydrochloride in water for injection. Each milliliter (mL) contains 0.4 mg naloxone hydrochloride and sodium chloride to adjust tonicity in water for injection. May contain hydrochloric acid for pH adjustment; pH 4.0 (3.0 to 6.5).
The single-dose solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection. When smaller doses are required, the unused portion should be discarded. The multiple-dose solution contains, in addition, 1.8 mg/mL methylparaben and 0.2 mg/mL propylparaben added as preservatives.
Naloxone Hydrochloride Injection, USP may be administered intravenously, intramuscularly, or subcutaneously. Naloxone, an opioid antagonist, is a synthetic congener of oxymorphone. It differs from oxymorphone in that the methyl group on the nitrogen atom is replaced by an allyl group.
Naloxone Hydrochloride, USP is chemically designated 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride (C19H21NO4 • HCl), a white to slightly off-white powder soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and chloroform. It has a molecular weight of 363.84. It has the following structural formula: Structure