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Naloxone Hydrochloride Injection, USP, Auto-Injector 10 mg/.4mL Injection, Solution, 10 doses — NDC 60842-002-02 (Billing 60842-0002-02)

by Kaleo, Inc. · 10 DOSE PACK in 1 CARTON / .4 mL in 1 DOSE PACK

This is a package of 10 doses of Naloxone Hydrochloride Injection, USP, Auto-Injector 10 mg/.4mL Injection, Solution from Kaleo, Inc., marketed since Feb 2022 and currently FDA-listed. It is this product's only package size.

NDC 60842-0002-02
🏷️ FDA NDC (as labeled) 60842-002-02 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 60842-002-02 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
60842 labeler · 002 product · 02 package
Package marketed since
Feb 28, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6084200202 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 60842-002-02
Product NDC 60842-002
11-digit billing NDC 60842000202
RxCUI 2596175
UNII F850569PQR
Application # NDA215457
SPL Set ID b5463553-b775-47a3-8d10-31e01ca1ec72
Established class (EPC) Opioid Antagonist
Mechanism of action Opioid Antagonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-02-28
Route INTRAMUSCULAR, SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance NALOXONE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 083121
GCN 51996
HICL code 001874
Ingredient (HICL) Naloxone Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H3
Therapeutic class — intermediate (HIC2) Analgesics
HIC3 code H3T
Therapeutic class — specific (HIC3) Opioid Antagonists
AHFS code 28:10.00.00
AHFS class Opioid Antagonists (28:10)
FDB label name NALOXONE 10 MG AUTO-INJECTOR
FDB brand name Naloxone Hcl (Stockpile)
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 083121
  • GCN: 51996
  • HICL (First Databank): 001874
  • AHFS class code: 28:10.00.00
  • RxCUI (RxNorm): 2596175
Why two NDCs? The FDA registers this code as 60842-002-02 — a 5-3-2 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 product segment → 60842-0002-02. 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.

Clinical

Label name NALOXONE 10 MG AUTO-INJECTOR Ingredient Naloxone Hcl
📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • It is an emergency medicine that reverses an opioid overdose. Signs include very slow or stopped breathing and being unresponsive. Some injection forms have extra hospital or milit...
  • Follow the instructions that came with your product. Nasal sprays go into one nostril. Zimhi goes into the outer thigh. Call 911 right away. If the person does not wake up or slips...
  • Naloxone can wear off before the opioid does. Breathing problems can come back. Stay with the person until emergency help arrives.
  • Why do I still need to call 911 if they wake up?
📖 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.

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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
60842-0002-02 You're viewing this Main listing 10 DOSE PACK in 1 CARTON / .4 mL in 1 DOSE PACK 2022-02-28 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Naloxone Hydrochloride Injection, USP, Auto-Injector 10 mg/.4mLthis 60842-0002-02 Kaleo, 10 doses — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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
First FDA approval
Feb 2022
📍
2026
Currently FDA-listed
4 years listed
🛡️
2031
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through May 2031. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Feb 28, 2022 RLD RS ⏳ ~4.6 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 10322239 — method of use (U-1907)
US 10143792 — method of use (U-2476)
US 9474869 — method of use (U-1907)
US 8939943 — drug product
US 9022022 — drug product
US 9814838 — drug product
2022 2024 2026 2028 2030
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (6)
PatentTypeUse codeExpires
US 10322239 ↗ Method of use U-1907 Feb 28, 2031
US 10143792 ↗ Method of use U-2476 May 24, 2031
US 9474869 ↗ Method of use U-1907 Feb 28, 2031
US 8939943 ↗ Drug product — Feb 28, 2031
US 9022022 ↗ Drug product — Feb 28, 2031
US 9814838 ↗ Drug product — Feb 28, 2031
Common questions
Is there a generic version of NALOXONE 10 MG AUTO-INJECTOR?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for NALOXONE 10 MG AUTO-INJECTOR. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until May 2031 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

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.

Manufacturer & labeler

LabelerKaleo, Inc.
Application holderKALEO INC
FDA applicationNDA215457 (NDA)
Labeler code60842
First marketedFeb 2022
Product typeHuman Prescription Drug

More NDCs from Kaleo, Inc. labeler code 60842

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.

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.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 147 words ▾

1 INDICATIONS AND USAGE NALOXONE HYDROCHLORIDE injection is indicated for use by military personnel and chemical incident responders for: Emergency treatment of patients 12 years of age and older where use of high-potency opioids such as fentanyl analogues as a chemical weapon is suspected. Temporary prophylaxis of respiratory and/or central nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids such as fentanyl analogues. NALOXONE HYDROCHLORIDE injection is an opioid antagonist indicated for use by military personnel and chemical incident responders for: Emergency treatment of patients 12 years of age and older where use of high-potency opioids such as fentanyl analogues as a chemical weapon is suspected.

( 1 ) Temporary prophylaxis of respiratory and/or central nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids such as fentanyl analogues. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Administer NALOXONE HYDROCHLORIDE injection according to the INSTRUCTIONS FOR USE. ( 2.1 ) Administer as soon as possible after known or suspected opioid exposure and seek emergency medical assistance immediately after the first dose. ( 2.1 ) Administer into the anterolateral aspect of the thigh, through clothing if necessary.

( 2.2 ) If the patient relapses into respiratory or central nervous system depression after the first dose, administer additional naloxone HCl, as necessary, until emergency medical assistance becomes available. ( 2.2 ) Keep the patient under continued surveillance until medical care is available. ( 2.2 )

2.1Important Administration Instructions Read the Instructions for Use at the time of receiving a single-dose, pre-filled NALOXONE HYDROCHLORIDE injection auto-injector. Administer NALOXONE HYDROCHLORIDE injection as soon as possible after known or suspected opioid exposure because prolonged respiratory depression may result in damage to the central nervous system or death. NALOXONE HYDROCHLORIDE injection contains 10 mg/0.4 mL naloxone HCl in a single-dose, pre-filled auto-injector for intramuscular or subcutaneous use only.

Do not attempt to reuse the NALOXONE HYDROCHLORIDE injection auto-injector. Periodically visually inspect NALOXONE HYDROCHLORIDE injection through the viewing window for particulate matter. Request a replacement if the solution is cloudy or contains particles, or if the glass container is damaged.

Once the red safety guard is removed, NALOXONE HYDROCHLORIDE injection auto-injector must be used immediately or disposed of properly. Do not attempt to replace the red safety guard once it is removed.

2.2Dosing in Adults and Pediatric Patients at Least 12 Years Old Inject NALOXONE HYDROCHLORIDE injection into the anterolateral aspect of the thigh according to the Instructions for Use and the printed instructions on the device label. In summary, Ensure that the injection site is free of other materials (e.g., equipment or other obstructions), except for clothing. Pull the auto-injector from the outer case.

When ready to use, firmly pull off the red safety guard. Do not touch the black base of the auto-injector, which is where the needle comes out. Place the black end of the auto-injector against the anterolateral aspect of the thigh, through clothing, if needed.

Press firmly until you hear a click and hiss sound and then hold in place for 5 seconds. Upon actuation, the auto-injector automatically inserts the needle intramuscularly or subcutaneously, delivers the naloxone HCl injection, and retracts the needle into the device. The needle will not be visible before, during, or after the injection.

Post-injection, the black base locks in place and a red indicator appears in the drug viewing window. NALOXONE HYDROCHLORIDE injection can be injected through clothing or MOPP4 PPE. NALOXONE HYDROCHLORIDE injection can be self- or buddy-administered.

Emergency treatment of patients 12 years of age and older where use of high-potency opioids such as fentanyl analogues as a chemical weapon is suspected. Seek immediate emergency medical assistance immediately after administration of the first dose of NALOXONE HYDROCHLORIDE injection. Keep the patient under continued surveillance until medical care is available.

If the patient relapses into respiratory and/or central nervous system depression after the first dose of NALOXONE HYDROCHLORIDE injection, administer additional naloxone HCl, as necessary, until emergency medical assistance becomes available. If the patient does not show some improvement after administering the dose of NALOXONE HYDROCHLORIDE injection, consider if the respiratory depression is due to a non-opioid etiology. Temporary prophylaxis of respiratory and/or central nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids such as fentanyl analogues.

Administer immediately prio… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 36 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 10 mg/0.4 mL naloxone HCl solution (equivalent to 9.0 mg naloxone base) in a single-dose pre-filled auto-injector. Injection: 10 mg/0.4 mL solution in a single-dose, pre-filled auto-injector. ( 3 )

⛔ Contraindications 41 words ▾

4 CONTRAINDICATIONS NALOXONE HYDROCHLORIDE injection is contraindicated in individuals known to be hypersensitive to naloxone HCl or to any of the other ingredients. Hypersensitivity to naloxone hydrochloride or to any of the other ingredients in NALOXONE HYDROCHLORIDE injection. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid dependent may cause abrupt opioid withdrawal. Monitor for the development of opioid withdrawal. Use of a product that delivers a dose lower than 10 mg of naloxone HCl may be preferable in treatment of a patient with known opioid dependence.

( 5.1 ) Risk of Recurrent Respiratory and Central Nervous System Depression: Due to the duration of action of naloxone HCl relative to the opioid, keep the patient under continued surveillance and administer additional naloxone HCl, as necessary, while awaiting emergency medical assistance. ( 5.2 )

5.1Precipitation of Severe Opioid Withdrawal The safety of NALOXONE HYDROCHLORIDE injection, 10 mg, in an auto-injector has not been established in opioid-dependent adults. Because NALOXONE HYDROCHLORIDE injection is expected to cause abrupt opioid withdrawal in opioid-dependent individuals, use NALOXONE HYDROCHLORIDE injection when the potential benefits are expected to outweigh the risks. Use of a product that delivers a dose lower than 10 mg naloxone HCl may be preferable in treatment of a patient with known opioid dependence.

Abrupt reversal of opioid depression after using naloxone HCl may result in nausea, vomiting, sweating, tremulousness, tachycardia, hypotension, hypertension, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest. Death, coma, and encephalopathy have been reported as sequelae of these events. Although a direct cause and effect relationship has not been established, after use of naloxone HCl, monitor individuals with opioid-dependence for hypotension, ventricular tachycardia or fibrillation, and pulmonary edema in an appropriate healthcare setting.

It has been suggested that the pathogenesis of pulmonary edema associated with the use of naloxone HCl is similar to neurogenic pulmonary edema, i.e., a centrally mediated massive catecholamine response leading to a dramatic shift of blood volume into the pulmonary vascular bed resulting in increased hydrostatic pressures.

5.2Risk of Recurrent Respiratory and Central Nervous System Depression The duration of action of most opioids may exceed that of naloxone HCl resulting in a return of respiratory and/or central nervous system depression after an initial improvement in symptoms. Therefore, it is necessary to seek emergency medical assistance immediately after delivering the first dose of NALOXONE HYDROCHLORIDE injection. Keep the patient under continued surveillance and administer additional naloxone HCl as necessary [ see Dosage and Administration (2.2) ].

Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Precipitation of Severe Opioid Withdrawal [see Warnings and Precautions (5.1) ] Recurrent Respiratory and Central Nervous System Depression [see Warnings and Precautions (5.2) ] The following adverse reactions were observed in more than one subject in clinical studies evaluating NALOXONE HYDROCHLORIDE injection: dizziness, feeling hot, headache, and injection site erythema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact kaleo, Inc. at 1-877-341-5330 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice. In three pharmacokinetic studies with a total of 78 healthy adult subjects exposed to NALOXONE HYDROCHLORIDE injection 0.4 mg auto-injector, two NALOXONE HYDROCHLORIDE injection 0.4 mg (0.8 mg naloxone HCl total) auto-injectors, NALOXONE HYDROCHLORIDE injection 2 mg auto-injector, or NALOXONE HYDROCHLORIDE injection 10 mg auto-injector, adverse reactions occurring in more than one subject were dizziness, feeling hot, headache, and injection site erythema.

6.2Postmarketing Experience The following adverse reactions have been identified during the use of naloxone HCl to reverse the effects of opioids. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: aggression, anger, anxiety, back pain, bradycardia, cardiac arrest, confusion, depression, disorientation, dyspnea, hypertension, hypotension, loss of consciousness, malaise, miosis, pain, pulmonary edema, somnolence, unresponsiveness to stimuli, and ventricular tachycardia and fibrillation.

Death, coma, and encephalopathy have been reported as sequelae of these events. Excessive doses of naloxone HCl have resulted in significant reversal of analgesia and have caused agitation [see Warnings and Precautions (5.1) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Life-sustaining therapy for opioid overdose should not be withheld (see Clinical Considerations ) . There is an absence of data on naloxone HCl administered for known or suspected opioid overdose in pregnant patients. Available data from retrospective cohort studies on oral naloxone use in pregnant women for opioid use disorder have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

In animal reproduction studies, no embryotoxic or teratogenic effects were observed in mice and rats treated with naloxone HCl during the period of organogenesis at doses equivalent to 4-times and 8-times, respectively, the dose of a 50 kg human given 10 mg naloxone HCl [see Data ] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk An opioid overdose is a medical emergency and can be fatal for the pregnant woman and fetus if left untreated. Treatment with NALOXONE HYDROCHLORIDE injection for opioid overdose should not be withheld because of potential concerns regarding the effects of NALOXONE HYDROCHLORIDE injection on the fetus.

Data Animal Data Naloxone HCl was administered during organogenesis to mice and rats at doses 4-times and 8-times, respectively, the dose of 10 mg/day given to a 50 kg human (when based on body surface area or mg/m 2 ). These studies demonstrated no embryotoxic or teratogenic effects due to naloxone HCl.

8.2Lactation Risk Summary Naloxone is minimally orally available and is unlikely to affect the breastfed infant. There is no information regarding the presence of naloxone in human milk, or the effects of naloxone on the breastfed infant or on milk production. Published studies in lactating women have shown that naloxone does not affect prolactin or oxytocin hormone levels.

8.4Pediatric Use The safety and effectiveness of NALOXONE HYDROCHLORIDE injection, 10 mg, in an auto-injector have been established in pediatric patients 12 years of age and older for emergency treatment where use of high-potency opioids such as fentanyl analogues as a chemical weapon is suspected. Use of NALOXONE HYDROCHLORIDE injection in this age group is supported by evidence from adult bioavailability studies, adult PK/PD modeling and simulation analysis supporting an effective dose, along with additional evidence from the reported safe and effective use of other naloxone HCl products [ see Clinical Pharmacology (12.2) ].

No pediatric studies were conducted for NALOXONE HYDROCHLORIDE injection. The safety and effectiveness of NALOXONE HYDROCHLORIDE injection for intramuscular and subcutaneous use have not been established for pediatric patients less than 12 years old. Absorption of naloxone HCl following subcutaneous or intramuscular administration in pediatric patients may be erratic or delayed.

Even when the opiate-intoxicated pediatric patient responds appropriately to naloxone HCl injection, the patient must be carefully monitored for at least 24 hours as a relapse may occur as naloxone is metabolized. In opioid-dependent pediatric patients, administration of naloxone HCl may result in an abrupt and complete reversal of opioid effects, precipitating an acute opioid withdrawal syndrome. In these settings where it may be preferable to avoid the abrupt precipitation of acute opioid withdrawal symptoms, consider use of an alternative naloxone HCl product that can be dosed according to weight and titrated to effect [see Warnings and Precautions (5.1) ] .

8.5Geriatric Use Clinical studies of naloxone HCl did not include suff… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Life-sustaining therapy for opioid overdose should not be withheld (see Clinical Considerations ) . There is an absence of data on naloxone HCl administered for known or suspected opioid overdose in pregnant patients. Available data from retrospective cohort studies on oral naloxone use in pregnant women for opioid use disorder have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

In animal reproduction studies, no embryotoxic or teratogenic effects were observed in mice and rats treated with naloxone HCl during the period of organogenesis at doses equivalent to 4-times and 8-times, respectively, the dose of a 50 kg human given 10 mg naloxone HCl [see Data ] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk An opioid overdose is a medical emergency and can be fatal for the pregnant woman and fetus if left untreated. Treatment with NALOXONE HYDROCHLORIDE injection for opioid overdose should not be withheld because of potential concerns regarding the effects of NALOXONE HYDROCHLORIDE injection on the fetus.

Data Animal Data Naloxone HCl was administered during organogenesis to mice and rats at doses 4-times and 8-times, respectively, the dose of 10 mg/day given to a 50 kg human (when based on body surface area or mg/m 2 ). These studies demonstrated no embryotoxic or teratogenic effects due to naloxone HCl.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of NALOXONE HYDROCHLORIDE injection, 10 mg, in an auto-injector have been established in pediatric patients 12 years of age and older for emergency treatment where use of high-potency opioids such as fentanyl analogues as a chemical weapon is suspected. Use of NALOXONE HYDROCHLORIDE injection in this age group is supported by evidence from adult bioavailability studies, adult PK/PD modeling and simulation analysis supporting an effective dose, along with additional evidence from the reported safe and effective use of other naloxone HCl products [ see Clinical Pharmacology (12.2) ].

No pediatric studies were conducted for NALOXONE HYDROCHLORIDE injection. The safety and effectiveness of NALOXONE HYDROCHLORIDE injection for intramuscular and subcutaneous use have not been established for pediatric patients less than 12 years old. Absorption of naloxone HCl following subcutaneous or intramuscular administration in pediatric patients may be erratic or delayed.

Even when the opiate-intoxicated pediatric patient responds appropriately to naloxone HCl injection, the patient must be carefully monitored for at least 24 hours as a relapse may occur as naloxone is metabolized. In opioid-dependent pediatric patients, administration of naloxone HCl may result in an abrupt and complete reversal of opioid effects, precipitating an acute opioid withdrawal syndrome. In these settings where it may be preferable to avoid the abrupt precipitation of acute opioid withdrawal symptoms, consider use of an alternative naloxone HCl product that can be dosed according to weight and titrated to effect [see Warnings and Precautions (5.1) ] .

🧓 Geriatric Use 77 words ▾

8.5Geriatric Use Clinical studies of naloxone HCl did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Geriatric patients have a greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.

Therefore, the systemic exposure of naloxone can be higher in these patients.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Naloxone HCl is an opioid antagonist that antagonizes opioid effects by competing for the same receptor sites. Naloxone HCl 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.

12.2Pharmacodynamics When naloxone HCl is administered intravenously, the onset of action is generally apparent within two minutes. The time to onset of action is shorter for intravenous compared to subcutaneous or intramuscular routes of administration. The duration of action is dependent upon the dose and route of administration of naloxone HCl.

Simulations based on data from healthy volunteer studies demonstrated that a single 10 mg naloxone HCl dose could improve depressed ventilation induced by morphine, buprenorphine, fentanyl, and carfentanil. The ability to reverse decreased ventilation rate after naloxone HCl treatment was dependent on the administered opioid, amount of opioid, amount of naloxone, and timing of naloxone HCl administration relative to opioid exposure.

12.3Pharmacokinetics A pharmacokinetic study using a crossover design was conducted in 24 fasted healthy subjects to evaluate a single 2 mg NALOXONE HYDROCHLORIDE injection (0.4 mL of 5 mg/mL naloxone HCl solution) and a single 10 mg NALOXONE HYDROCHLORIDE injection (0.4 mL of 25 mg/mL naloxone HCl solution) administered to the anterolateral aspect of the thigh. Plasma samples were analyzed for naloxone 12-hours post dose. The pharmacokinetic parameters obtained in this study are shown in Table 1 and the plasma concentration time profiles of naloxone are presented in Figure 1 .

A slightly greater than 5-fold increase was observed for 10 mg NALOXONE HYDROCHLORIDE injection compared to 2 mg NALOXONE HYDROCHLORIDE injection for the mean pharmacokinetic parameters of C max , AUC 0-t , and AUC 0-inf . Table 1 Mean Pharmacokinetic Parameters (%CV) for Naloxone Following NALOXONE HYDROCHLORIDE injection Intramuscular/Subcutaneous Administration to Healthy Subjects † T max reported as median (minimum, maximum) Parameter 2 mg NALOXONE HYDROCHLORIDE injection (N=24) 10 mg NALOXONE HYDROCHLORIDE injection (N=24) T max (h)† 0.17 (0.08, 0.67) 0.26 (0.09, 0.67) C max (ng/mL) 6.95 (44.8) 42.0 (49.9) AUC 0-t (ng.h/mL) 9.22 (14.6) 51.1 (17.9) AUC 0-inf (ng.h/mL) 9.25 (14.6) 51.3 (17.8) T 1/2 (h) 1.46 (11.1) 1.46 (14.1) Figure 1 Mean ± SD Plasma Concentration of Naloxone, (a) 0-8 h and (b) 0-3 h Following Intramuscular/Subcutaneous Administration using NALOXONE HYDROCHLORIDE injection (a) (b) Absorption The median T max for NALOXONE HYDROCHLORIDE injection is 15.6 minutes (range 5.4 to 40.2 minutes).

Distribution Following parenteral administration, naloxone is distributed in the body and readily crosses the placenta. Plasma protein binding occurs but is relatively weak. Plasma albumin is the major binding constituent, but significant binding of naloxone also occurs to plasma constituents other than albumin.

It is not known whether naloxone is excreted into human milk. Elimination The mean plasma half-life of naloxone in healthy adults was 1.46 hours (14.1%CV) following a single administration of NALOXONE HYDROCHLORIDE injection. Metabolism Naloxone HCl is metabolized in the liver, primarily by glucuronide conjugation with naloxone-3-glucoronide as the major metabolite.

Excretion After an oral or intravenous dose, about 25-40% of naloxone is excreted as metabolites in urine within 6 hours, about 50% in 24 hours, and 60-70% in 72 hours. figure1a figure1b

🧬 Mechanism of Action 48 words ▾

12.1Mechanism of Action Naloxone HCl is an opioid antagonist that antagonizes opioid effects by competing for the same receptor sites. Naloxone HCl 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.

📦 How Supplied / Storage and Handling 173 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied NALOXONE HYDROCHLORIDE injection, a colorless to yellow solution of 10 mg/0.4 mL naloxone HCl, provided as follows: NDC 60842-002-02: Package containing ten single-dose 10 mg/0.4 mL auto-injectors

16.2Storage and Handling Storage and Shipping Store at controlled room temperature 15°C - 25°C (59°F - 77°F); excursions permitted between 4°C and 40°C (39°F and 104°F). Do not freeze. Protect from heat.

Use and Handling Store the NALOXONE HYDROCHLORIDE injection auto-injector in the outer case provided. If NALOXONE HYDROCHLORIDE injection is frozen and is needed in an emergency, do NOT wait for NALOXONE HYDROCHLORIDE injection to thaw; get emergency medical help right away. Once thawed, NALOXONE HYDROCHLORIDE injection may be used.

Manufactured for: Kaleo, Inc. Richmond, VA 23219 This product may be covered by one or more U.S. patents or pending patent applications. See www.kaleopharma.com/pat for details.

16.1How Supplied NALOXONE HYDROCHLORIDE injection, a colorless to yellow solution of 10 mg/0.4 mL naloxone HCl, provided as follows: NDC 60842-002-02: Package containing ten single-dose 10 mg/0.4 mL auto-injectors

📦 Storage and Handling 108 words ▾

16.2Storage and Handling Storage and Shipping Store at controlled room temperature 15°C - 25°C (59°F - 77°F); excursions permitted between 4°C and 40°C (39°F and 104°F). Do not freeze. Protect from heat.

Use and Handling Store the NALOXONE HYDROCHLORIDE injection auto-injector in the outer case provided. If NALOXONE HYDROCHLORIDE injection is frozen and is needed in an emergency, do NOT wait for NALOXONE HYDROCHLORIDE injection to thaw; get emergency medical help right away. Once thawed, NALOXONE HYDROCHLORIDE injection may be used.

Manufactured for: Kaleo, Inc. Richmond, VA 23219 This product may be covered by one or more U.S. patents or pending patent applications. See www.kaleopharma.com/pat for details.

📋 Description 137 words ▾

11 DESCRIPTION NALOXONE HYDROCHLORIDE injection, USP, for intramuscular or subcutaneous use, is an opioid antagonist in a pre-filled, single-dose auto-injector containing 10 mg of naloxone HCl in 0.4 mL solution. NALOXONE HYDROCHLORIDE injection is not made with natural rubber latex. Chemically, naloxone HCl is the hydrochloride salt of 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride with the following structure: C 19 H 21 NO 4 HC1 M.W.363.84 Naloxone HCl 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.

Each 0.4 mL of NALOXONE HYDROCHLORIDE injection contains 10 mg of naloxone HCl (equivalent to 9.0 mg naloxone base), 3.34 mg of sodium chloride, hydrochloric acid to adjust pH, and water for injection. The pH range is 3.0 to 4.5. chemical structure

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics A pharmacokinetic study using a crossover design was conducted in 24 fasted healthy subjects to evaluate a single 2 mg NALOXONE HYDROCHLORIDE injection (0.4 mL of 5 mg/mL naloxone HCl solution) and a single 10 mg NALOXONE HYDROCHLORIDE injection (0.4 mL of 25 mg/mL naloxone HCl solution) administered to the anterolateral aspect of the thigh. Plasma samples were analyzed for naloxone 12-hours post dose. The pharmacokinetic parameters obtained in this study are shown in Table 1 and the plasma concentration time profiles of naloxone are presented in Figure 1 .

A slightly greater than 5-fold increase was observed for 10 mg NALOXONE HYDROCHLORIDE injection compared to 2 mg NALOXONE HYDROCHLORIDE injection for the mean pharmacokinetic parameters of C max , AUC 0-t , and AUC 0-inf . Table 1 Mean Pharmacokinetic Parameters (%CV) for Naloxone Following NALOXONE HYDROCHLORIDE injection Intramuscular/Subcutaneous Administration to Healthy Subjects † T max reported as median (minimum, maximum) Parameter 2 mg NALOXONE HYDROCHLORIDE injection (N=24) 10 mg NALOXONE HYDROCHLORIDE injection (N=24) T max (h)† 0.17 (0.08, 0.67) 0.26 (0.09, 0.67) C max (ng/mL) 6.95 (44.8) 42.0 (49.9) AUC 0-t (ng.h/mL) 9.22 (14.6) 51.1 (17.9) AUC 0-inf (ng.h/mL) 9.25 (14.6) 51.3 (17.8) T 1/2 (h) 1.46 (11.1) 1.46 (14.1) Figure 1 Mean ± SD Plasma Concentration of Naloxone, (a) 0-8 h and (b) 0-3 h Following Intramuscular/Subcutaneous Administration using NALOXONE HYDROCHLORIDE injection (a) (b) Absorption The median T max for NALOXONE HYDROCHLORIDE injection is 15.6 minutes (range 5.4 to 40.2 minutes).

Distribution Following parenteral administration, naloxone is distributed in the body and readily crosses the placenta. Plasma protein binding occurs but is relatively weak. Plasma albumin is the major binding constituent, but significant binding of naloxone also occurs to plasma constituents other than albumin.

It is not known whether naloxone is excreted into human milk. Elimination The mean plasma half-life of naloxone in healthy adults was 1.46 hours (14.1%CV) following a single administration of NALOXONE HYDROCHLORIDE injection. Metabolism Naloxone HCl is metabolized in the liver, primarily by glucuronide conjugation with naloxone-3-glucoronide as the major metabolite.

Excretion After an oral or intravenous dose, about 25-40% of naloxone is excreted as metabolites in urine within 6 hours, about 50% in 24 hours, and 60-70% in 72 hours. figure1a figure1b

🧬 Pharmacodynamics 113 words ▾

12.2Pharmacodynamics When naloxone HCl is administered intravenously, the onset of action is generally apparent within two minutes. The time to onset of action is shorter for intravenous compared to subcutaneous or intramuscular routes of administration. The duration of action is dependent upon the dose and route of administration of naloxone HCl.

Simulations based on data from healthy volunteer studies demonstrated that a single 10 mg naloxone HCl dose could improve depressed ventilation induced by morphine, buprenorphine, fentanyl, and carfentanil. The ability to reverse decreased ventilation rate after naloxone HCl treatment was dependent on the administered opioid, amount of opioid, amount of naloxone, and timing of naloxone HCl administration relative to opioid exposure.

🧪 Nonclinical Toxicology 112 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term animal studies to evaluate the carcinogenic potential of naloxone have not been completed. Mutagenesis Naloxone was weakly positive in the Ames mutagenicity and in the in vitro human lymphocyte chromosome aberration test but was negative in the in vitro Chinese hamster V79 cell HGPRT mutagenicity assay and in the in vivo rat bone marrow chromosome aberration study. Impairment of Fertility Reproduction studies conducted in mice and rats at doses 4-times and 8-times, respectively, the dose of a 50 kg human given 10 mg/day (when based on surface area or mg/m 2 ), demonstrated no adverse effect of naloxone HCl on fertility.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 109 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term animal studies to evaluate the carcinogenic potential of naloxone have not been completed. Mutagenesis Naloxone was weakly positive in the Ames mutagenicity and in the in vitro human lymphocyte chromosome aberration test but was negative in the in vitro Chinese hamster V79 cell HGPRT mutagenicity assay and in the in vivo rat bone marrow chromosome aberration study. Impairment of Fertility Reproduction studies conducted in mice and rats at doses 4-times and 8-times, respectively, the dose of a 50 kg human given 10 mg/day (when based on surface area or mg/m 2 ), demonstrated no adverse effect of naloxone HCl on fertility.

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE NALOXONE HYDROCHLORIDE injection (Nuh-laak-sown hai-drow-klaw-ride) for intramuscular or subcutaneous use Read the Instructions for Use that comes with NALOXONE HYDROCHLORIDE injection before using it. NALOXONE HYDROCHLORIDE injection comes in a single-dose, pre-filled auto-injector. NALOXONE HYDROCHLORIDE injection is indicated for use by military personnel and chemical incident responders for: Emergency treatment of people 12 years of age and older where use of high-potency opioids such as fentanyl analogues as a chemical weapon is suspected.

Temporary prevention (prophylaxis) of either breathing problems (respiratory depression), decreased brain and nerve function (central nervous system depression), or both in military personnel and chemical incident responders entering an area contaminated with high-potency opioids such as fentanyl analogues. Important: Administer NALOXONE HYDROCHLORIDE injection as soon as possible after known or suspected opioid exposure. If an individual is unresponsive and opioid exposure is suspected, administer NALOXONE HYDROCHLORIDE injection as quickly as possible because an opioid emergency can cause severe injury or death.

Each NALOXONE HYDROCHLORIDE injection auto-injector can only be used 1 time. You do not need to assemble your auto-injector. It comes already assembled for use.

Figure A – NALOXONE HYDROCHLORIDE injection auto-injector Parts Important note: Before you use the NALOXONE HYDROCHLORIDE injection auto-injector, look at the viewing window. Do not use the auto-injector if the medicine is cloudy or contains particles or if there is a red indicator in the viewing window. Use a new NALOXONE HYDROCHLORIDE injection auto-injector.

How to use the auto-injector: Step 1. Firmly pull the auto-injector from the outer case. See Figure B .

Do not go to Step 2 (Do not remove the Red safety guard) until you are ready to use the auto-injector. If you are not ready to use the auto-injector, put it back in the outer case for later use. If NALOXONE HYDROCHLORIDE injection auto-injector is frozen, do not wait for it to thaw.

Use another auto-injector if available. If another auto-injector is not available, get emergency medical help right away. NALOXONE HYDROCHLORIDE injection auto-injector may still be used if it has been thawed after being previously frozen.

Step 2. Pull off the Red safety guard. See Figure C .

To reduce the chance of an accidental injection, do not touch the Black base of the auto-injector, which is where the needle comes out Note: The Red safety guard is made to fit tightly. Pull firmly to remove. Do not replace the Red safety guard after it is removed.

Step 3. Place the Black end of the auto-injector against the outer thigh, through clothing or personal protective equipment (including MOPP4 PPE), if needed. Make sure that the injection site is free of other materials such as equipment or other obstructions, except for clothing.

NALOXONE HYDROCHLORIDE injection auto-injector may be self-administered or administered by a buddy. Press firmly until you hear a click and hiss sound and then hold in place for 5 seconds . See Figure D .

Note: The auto-injector makes a distinct sound (click and hiss) when it is pressed against the thigh. The click and hiss indicates the start of the injection. This is normal and means that the auto-injector is working correctly.

Keep the auto-injector firmly pressed against the thigh for 5 seconds after you hear the click and hiss sound. After the medicine is injected, the needle will retract back up into the auto-injector and is not visible after use. Step 4.

After administering the first dose of NALOXONE HYDROCHLORIDE injection, get emergency medical help right away. Rescue breathing or CPR (cardiopulmonary resuscitation) may be given while waiting for emergency medical help. If there is no response to NALOXONE HYDROCHLORIDE injection consider if respiratory depression is caused by something other than opioid exposure.

Watch the pers… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 38 words ▾

PRINCIPAL DISPLAY PANEL - NDC: 60842-002-02 - 10 mg Auto-injector Carton Label Auto-injectors Label

PRINCIPAL DISPLAY PANEL - NDC: 60842-002-02 - Device Label Device Label

PRINCIPAL DISPLAY PANEL - NDC: 60842-002-02 - Outer Case Label Outer Case Label

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

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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 Kaleo, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Kaleo, 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.
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?
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← 60833-0001-01 · Lakeshore 60842-0021-01 · kaleo, →
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.