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Naloxone Hydrochloride .4 mg/mL Injection, Solution, 1 cartridge — NDC 00404-9920-01 package photo

Naloxone Hydrochloride .4 mg/mL Injection, Solution, 1 cartridge

by Henry Schein, Inc. · 1 BOX in 1 BAG (0404-9920-01) / 1 CARTRIDGE in 1 BOX / 1 mL in 1 CARTRIDGE
NDC 00404-9920-01
🏷️ FDA NDC (as labeled) 0404-9920-01 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 0404-9920-01
Product NDC 0404-9920
11-digit billing NDC 00404992001
RxCUI 1191234
UNII F850569PQR
Application # ANDA070172
SPL Set ID d39635a4-ddb3-4d32-8211-eb84c78e9f59
Established class (EPC) Opioid Antagonist
Mechanism of action Opioid Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-01-13
Route INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance NALOXONE HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 0404-9920-01 — a 4-4-2 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 labeler segment → 00404-9920-01. 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.

🏷️ RxNorm drug class

This medicine belongs to the Opioid Antagonist class.

Pharmacologic class Opioid Antagonist
Drug family (ATC) Other opioids, Natural opium alkaloids, Benzomorphan derivatives
How it works 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.

🏭 Manufacturer & labeler

LabelerHenry Schein, Inc.
Application holderHOSPIRA INC
FDA applicationANDA070172 (ANDA)
Labeler code00404
First marketedJan 2022
Product typeHuman Prescription Drug
Portfolio171 products on file
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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • 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...
  • How do I actually use the nasal spray, and what if it doesn't seem to work?
📖 Read our full Naloxone guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Naloxone Hydrochloride — tap one for details:

1,4-butanediolModerate Gamma Butyrolactone (gbl)Moderate Gamma-hydroxybutyrate (ghb)Moderate
🌿 Every supplement checked against Naloxone Hydrochloride (3 interactions) — ranked by severity →
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.

🧪 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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.

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.

💲 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 systemPer mLPer 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 $53.82 $53.82 / 1 ml
Medicare Part B allowsASP · J2312 $0.069 / J2312 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.

🧾 Billing & reimbursement

FDA NDC (as labeled)0404-9920-01
11-digit billing NDC00404-9920-01
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ2312
Descriptor0.01 MG
Billing units / pkg40 units
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Naloxone Hydrochloride .4 mg/mL 67457-0292-02 Mylan 10 vials $4.015 AP Discontinued —
Naloxone Hydrochloride .4 mg/mL 36000-0310-02 Baxter 1 vial $4.015 AP Availability likely —
Naloxone Hydrochloride .4 mg/mL 00409-1215-01 Hospira, 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 36000-0308-10 Baxter 10 vials $4.015 AP Availability likely —
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 55150-0327-10 Eugia 10 vials $6.488 — FDA listed —
Naloxone Hydrochloride .4 mg/mLthis 00404-9920-01 Henry 1 cartridge — AP FDA listed —
Naloxone Hydrochloride .4 mg/mL 00409-1782-69 Hospira, 10 cartridges — AP FDA listed —
Naloxone Hydrochloride .4 mg/mL 51662-1238-01 HF 1 ml — AP FDA listed —
Naloxone Hydrochloride .4 mg/mL 67457-0299-10 Mylan 10 vials — AP FDA listed —
Naloxone Hydrochloride .4 mg/mL 50090-6491-00 A-S 10 vials — AP FDA listed —
Naloxone Hydrochloride .4 mg/mL 70069-0072-10 Somerset 1 vial — AP FDA listed —
Naloxone Hydrochloride .4 mg/mL 71872-7198-01 Medical 1 vial — AP FDA listed —
Naloxone Hydrochloride .4 mg/mL 71872-7215-01 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 51662-1544-01 HF 1 ml — — FDA listed —
Naloxone Hydrochloride .4 mg/mL 84549-0072-10 ProPharma 10 ml — AP FDA listed —
Naloxone Hydrochloride .4 mg/mL 76045-0114-10 Fresenius 24 syringes — AP FDA listed —
Naloxone Hydrochloride .4 mg/mL 51662-1671-03 HF 25 vials — AP FDA listed —
Naloxone Hydrochloride .4 mg/mL 51662-1426-01 HF 1 vial — AP FDA listed —
Naloxone Hydrochloride .4 mg/mL 71872-7326-01 Medical 1 vial — AP FDA listed —
Naloxone Hydrochloride .4 mg/mL 51662-1385-01 HF 1 vial — AP FDA listed —
Naloxone Hydrochloride .4 mg/mL 51662-1673-01 HF 10 ml — AP FDA listed —
Naloxone Hydrochloride .4 mg/mL 00404-9923-01 Henry 1 vial — AP Discontinued —
Naloxone Hydrochloride .4 mg/mL 50090-5427-00 A-S 10 vials — AP FDA listed —
Naloxone Hydrochloride .4 mg/mL 84549-0071-10 ProPharma 1 ml — AP FDA listed —
Naloxone Hydrochloride .4 mg/mL 55150-0328-10 Eugia 10 vials — AP FDA listed —
Naloxone Hydrochloride .4 mg/mL 00404-9773-01 Henry 1 vial — AP FDA listed —
Naloxone Hydrochloride .4 mg/mL 00409-1219-01 Hospira, 1 vial — AP FDA listed —
Naloxone Hydrochloride .4 mg/mL 00641-6193-10 Hikma 10 syringes — AP FDA listed —
Naloxone Hydrochloride .4 mg/mL 70385-2033-01 Sina 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.

⏳ Availability & generic status

🏛️
2022
On the market since
Jan 2022
📍
2026
Currently FDA-listed
4 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00404-9920-01 You're viewing this 1 BOX in 1 BAG (0404-9920-01) / 1 CARTRIDGE in 1 BOX / 1 mL in 1 CARTRIDGE 2022-01-13 Active

🧭 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 ✓ Available
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 FDA registers it as 0404-9920-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00404-9920-01, written without dashes as 00404992001. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00404-9920-01, the first segment (00404) is the labeler code FDA assigned to Henry Schein, Inc.; the middle segment (9920) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Henry Schein, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Henry Schein, Inc. 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 J2312 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 83 words ▾

INDICATIONS AND 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 hydrochloride injection 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 204 words ▾

DOSAGE AND ADMINISTRATION Naloxone hydrochloride injection 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 may be diluted for intravenous infusion in 0.9% sodium chloride 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 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 unless its effect on the chemical and physical stability of the solution has first been established. General Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

⛔ Contraindications 25 words ▾

CONTRAINDICATIONS Naloxone hydrochloride injection is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or any of the other ingredients contained in the formulation.

⚠️ Warnings 212 words ▾

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 ~1 min read ▾

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 is 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, 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 flushes, or flushing See also PRECAUTIONS and DOSAGE AND ADMINISTRATION: USAGE IN ADULTS, Postoperative Opioid Depression .

🆘 Overdosage ~1 min read ▾

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 ~2 min read ▾

CLINICAL PHARMACOLOGY Naloxone prevents or reverses the effects of opioids including respiratory depression, sedation and hypotension. Also, it 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 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, withdrawal symptoms will 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 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 dissipate. The requirement for repeat doses of naloxone 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 150 words ▾

HOW SUPPLIED Naloxone hydrochloride injection, USP for intravenous, intramuscular, and subcutaneous administration is available as: Instructions for Use of the Syringe Systems Needle not included. Instructions for using the Carpuject Syringe are available with the reusable Carpuject Holder, List 2049-02. Protect from light.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 0409-1782-69 1 mL fill in 2.5 mL Carpuject™ Single-dose cartridge with Luer Lock for the Carpuject™ Syringe System NDC 0404-9920-01 1 1 mL fill in 2.5 mL Carpuject™ Single-dose cartridge with Luer Lock for the Carpuject™ Syringe System in a bag (Vial bears NDC 0409-1782-03) 0.4 mg/mL Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1215-3.0 Revised: 03/2023 Image1.jpg

📋 Description 142 words ▾

DESCRIPTION Naloxone hydrochloride, an opioid antagonist, is a synthetic congener of oxymorphone. In structure it differs from oxymorphone in that the methyl group on the nitrogen atom is replaced by an allyl group. It is known chemically as 17-allyl-4,5α-epoxy,3-14-dihydroxymorphinan-6-one hydrochloride.

It has a molecular weight of 363.84, and the following structural formula: Naloxone hydrochloride occurs as a white to slightly off-white powder, and is soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and in chloroform. Naloxone hydrochloride injection is available as a sterile solution for intravenous, intramuscular, and subcutaneous administration. Each mL contains 0.4 mg of naloxone hydrochloride.

Each mL contains 8.9 mg of sodium chloride. The pH is adjusted between 3.0 to 6.5 with hydrochloric acid or sodium hydroxide. The air in the cartridges has been displaced by nitrogen gas.

Formula1.jpg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00404-9918-01 · Henry 00404-9922-02 · Henry →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.