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ZIMHI Naloxone Hydrochloride 5 mg/.5mL Injection, Solution, 1 syringe

by ZMI Pharma Inc. · 1 CASE in 1 CARTON (84571-140-11) / 1 SYRINGE in 1 CASE / .5 mL in 1 SYRINGE
NDC 84571-0140-11
🏷️ FDA NDC (as labeled) 84571-140-11 billing pads the product segment with a zero
This package
Contains1 syringe Pack sizes2 compare ↓
Also comes in: 1 syringe 84571-0140-02
Rx only Brand 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) 84571-140-11
Product NDC 84571-140
11-digit billing NDC 84571014011
RxCUI 2589612, 2589618
UNII F850569PQR
Application # NDA212854
SPL Set ID 523c0909-bff6-4010-988a-53de18b7cb3f
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 2022-01-15
Route INTRAMUSCULAR, SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance NALOXONE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 84571-140-11 — 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 → 84571-0140-11. 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

LabelerZMI Pharma Inc.
Application holderZMI PHARMA INC
FDA applicationNDA212854 (NDA)
Labeler code84571
First marketedJan 2022
Product typeHuman Prescription Drug
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 works by knocking opioids off their receptors in the brain — the spots opioids attach to in order to cause their effects. When those receptors are blocked by naloxone, bre...
  • What exactly does naloxone injection do in an overdose?
  • Call 911 immediately — that's not optional. Naloxone wears off faster than most opioids, so even if the person wakes up and seems okay, they can slip back into overdose once the na...
  • What do I do after I give someone a dose of naloxone injection?
📖 Read our full Naloxone Injection 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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.
  • 4.17 mg / 0.5 mL 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.
  • 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.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

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 · 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.
Try another pack size: 1 syringe
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Zimhi 5 mg/.5mLthis 84571-0140-11 ZMI 1 syringe — — 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

🏛️
2021
First FDA approval
Oct 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2041
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 Jun 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 15, 2021 RLD RS ⏳ ~14.7 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 11571518 — method of use (U-3515)
US 11571518 — method of use (U-3516)
US 11571518 — method of use (U-3517)
US 11027072 — drug product
2021 2023 2025 2027 2029 2031 2033 2035 2037 2039 2041
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 (4)
PatentTypeUse codeExpires
US 11571518 ↗ Method of use U-3515 Jun 14, 2041
US 11571518 ↗ Method of use U-3516 Jun 14, 2041
US 11571518 ↗ Method of use U-3517 Jun 14, 2041
US 11027072 ↗ Drug product — May 24, 2039
Common questions
Is there a generic version of this drug?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for this drug. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jun 2041 — 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for ZIMHI (this brand).

Top reported reactions

Toxicity To Various Agents82
Vomiting58
Fatigue48
Drug Withdrawal Syndrome46
Overdose46
Nausea44
Diarrhoea40

Age at onset

Neonate7
Infant5
Child3
Adolescent6
Adult179
Elderly49

Reporter sex

918 reports
Male · 54%
Female · 46%
Unknown · 0%

Serious outcomes

Hospitalization404
Death137
Life-threatening81
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 128 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
84571-0140-02 2 CASE in 1 CARTON (84571-140-02) / 1 SYRINGE in 1 CASE / .5 mL in 1 SYRINGE 2022-01-15 Active
84571-0140-11 You're viewing this 1 CASE in 1 CARTON (84571-140-11) / 1 SYRINGE in 1 CASE / .5 mL in 1 SYRINGE 2022-01-15 Active

Pack size FAQ

What quantity is in NDC 84571-0140-11?
NDC 84571-0140-11 contains 1 syringe — 1 case in 1 carton / 1 syringe in 1 case / .5 ml in 1 syringe.
What NDC number is used to bill for this package of ZIMHI Naloxone Hydrochloride 5 mg/.5mL Injection, Solution?
Bill NDC 84571-0140-11 — the 11-digit billing format is 84571014011. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ 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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
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 84571-140-11, 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: 84571-0140-11, written without dashes as 84571014011. 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 84571-0140-11, the first segment (84571) is the labeler code FDA assigned to ZMI Pharma Inc.; the middle segment (0140) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (11) 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 ZMI Pharma Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 syringe (84571-0140-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
ZMI Pharma 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?
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 💊 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 💬 Information for Patients
🎯 Indications and Usage 115 words ▾

1. INDICATIONS AND USAGE ZIMHI is indicated in adults and pediatric patients for: the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. ZIMHI is intended for immediate administration as emergency therapy in settings where opioids may be present.

ZIMHI is not a substitute for emergency medical care. ZIMHI is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. ( 1 ) ZIMHI is intended for immediate administration as emergency therapy in settings where opioids may be present.

( 1 ) ZIMHI is not a substitute for emergency medical care. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2. DOSAGE AND ADMINISTRATION ZIMHI is for intramuscular or subcutaneous use only. ( 2.1 ) Seek emergency medical care immediately after use.

( 2.1 ) ZIMHI is intended to be administered by individuals 12 years of age or older. ( 2.1 ) Administer ZIMHI to adult or pediatric patients into the anterolateral aspect of the thigh, through clothing if necessary. ( 1 ) See the Full Prescribing Information and Instructions for Use for important information on how to safely administer ZIMHI.

( 2.1 ) Keep the patient under continued surveillance until emergency personnel arrive and administer repeated doses of ZIMHI as necessary. ( 2.1 ) Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance. ( 2.2 ) In pediatric patients under the age of one, the caregiver should pinch the thigh muscle while administering the dose.

( 2.2 )

2.1Important Administration Instructions ZIMHI is for intramuscular and subcutaneous use only. Because treatment of known or suspected opioid overdose must be performed by someone other than the patient, instruct the prescription recipient to inform those around them about the presence of ZIMHI and the Instructions for Use. ZIMHI is intended to be administered by individuals 12 years of age or older.

Younger individuals or those with limited hand strength may find the device difficult to use. ZIMHI is light sensitive. Store ZIMHI in the outer case provided to protect it from light.

Prior to a medical emergency (during storage), periodically visually inspect ZIMHI through the viewing window on the device. If the solution is discolored yellow or brown color, cloudy, or contains particles, replace ZIMHI with a new one [ see How Supplied/Storage and Handling ( 16.2 ) ]. Do not attempt to reuse ZIMHI.

Each ZIMHI contains a single-dose of naloxone hydrochloride for single-dose injection. Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for ZIMHI ® . Emphasize the following instructions to the patient or caregiver: Seek emergency medical care immediately after use .

Because the duration of action of most opioids exceeds that of naloxone hydrochloride and the suspected opioid overdose may occur outside of supervised medical settings, seek immediate emergency medical assistance, keep the patient under continued surveillance until emergency personnel arrive, and administer repeated doses of ZIMHI as necessary. Always seek emergency medical assistance in the event of a suspected potentially life-threatening opioid emergency after administration of the first dose of ZIMHI. Additional doses of ZIMHI may be required until emergency medical assistance becomes available [ see Dosage and Administration ( 2.2 ) ].

Administer ZIMHI according to the Instructions for Use and the printed instructions on the device label: - Place the patient in the supine position. - Inject ZIMHI intramuscularly or subcutaneously into the anterolateral aspect of the thigh with the needle facing downwards. Inject through clothing if necessary [ see Instructions for Use ]. - Embed the needle completely before transferring the thumb to the syringe plunger. - Immediately after injection, using one hand with fingers behind the needle, slide the safety guard over the needle.

Do not use two hands to activate the safety guard. - Never put thumb, fingers , or hand over the exposed needle. Failure to follow these instructions may result in a needlestick injury . If an accidental needlestick occurs, get medical help immediately [ see Warnings and Precautions ( 5.4 ) ]. - Do NOT attempt to re-cap the needle with the needle cap once it has been removed [ see Warnings and Precautions ( 5.4 )] . - Place the patient in the lateral recumbent position (recovery position). - ZIMHI must be used and/or properly disposed of as described below once the protective cap covering the needle is removed. - Put the used syringe into the blue case, close the case, and give y…

💊 Dosage Forms and Strengths 58 words ▾

3. DOSAGE FORMS AND STRENGTHS Injection: 5 mg/0.5 mL naloxone hydrochloride is a clear, colorless to slightly yellow, sterile solution in a single-dose, pre-filled syringe. Each ZIMHI 5 mg delivers 5 mg naloxone hydrochloride (equivalent to 4.5 mg naloxone) injection, USP (0.5 mL). Injection: 5 mg/0.5 mL naloxone hydrochloride solution in a pre-filled prefilled syringe. ( 3 )

⛔ Contraindications 37 words ▾

4. CONTRAINDICATIONS ZIMHI is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients. Hypersensitivity to naloxone hydrochloride or to any of the other ingredients in ZIMHI. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5. WARNINGS AND PRECAUTIONS Risk of Recurrent Respiratory and CNS Depression : Due to the duration of action of naloxone relative to the opioid, respiratory and CNS depression may recur after the first dose of naloxone. Seek emergency medical assistance immediately after the first dose, keep the patient under continued surveillance, and administer repeated doses of naloxone using a new ZIMHI, as necessary, while awaiting emergency medical assistance.

( 5.1 ) Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists : Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required. ( 5.2 ) Precipitation of Severe Opioid Withdrawal : Use in patients who are opioid dependent results in rapid onset of opioid withdrawal.

In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated. Monitor for the development of opioid withdrawal. ( 5.3 ) Risk of Cardiovascular (CV) Effects : Abrupt postoperative reversal of opioid depression may result in adverse CV effects.

These events have primarily occurred in patients who had pre-existing CV disorders or received other drugs that may have similar CV effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone hydrochloride. ( 5.3 ) Risk of Accidental Needlestick Injury : After use, the ZIMHI needle is exposed until the safety guard is deployed.

Stress to patients the importance of familiarizing themselves with the device and its operation prior to experiencing an emergency situation, and to immediately seek medical attention should a needlestick occur. ( 5.4 )

5.1Risk of Recurrent Respiratory and Central Nervous System Depression The duration of action of most opioids may exceed that of ZIMHI 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 ZIMHI. Keep the patient under continued surveillance and administer additional doses of ZIMHI if the patient is not adequately responding or responds and then relapses back into respiratory depression, as necessary [ see Dosage and Administration ( 2.2 ) ].

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

5.2Risk of Limited Efficacy with Partial Agonists or Mixed Agonist/Antagonists Reversal of respiratory depression by partial agonists or mixed agonist/antagonists such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses of naloxone hydrochloride may be required to antagonize buprenorphine because the latter has a long duration of action due to its slow rate of binding and subsequent slow dissociation from the opioid receptor [ see Dosage and Administration ( 2 ) ]. Buprenorphine antagonism is characterized by a gradual onset of the reversal effects and a decreased duration of action of the normally prolonged respiratory depression.

5.3Precipitation of Severe Opioid Withdrawal The use of ZIMHI in patients who are opioid dependent results in opioid withdrawal characterized by rapid onset of severe body aches, vomiting, diarrhea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may include the following signs and symptoms: convulsions, excessive crying, and hyperactive reflexes.

Monitor patients for the development of the signs and symptoms of opioid withdrawal. Abrupt postoperative reversal of opioid depression after using naloxone hydrochloride may result in nausea, vomiting, sweating, tremulousness, tachycardia, hypotension,…

🤒 Adverse Reactions ~2 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 ( 5.3 )] 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. The following adverse reactions were observed in ZIMHI clinical studies in healthy volunteers without opioid dependence: nausea, dizziness, lightheadedness, and elevated bilirubin.

The following adverse reactions have been identified during post-approval use of naloxone hydrochloride in the post-operative setting. 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: 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 hydrochloride in post-operative patients have resulted in significant reversal of analgesia and have caused agitation [ see Warnings and Precautions ( 5.3 ) ]. Other events that have been reported in post-marketing use of naloxone hydrochloride include agitation, disorientation, confusion, and anger. Abrupt reversal of opioid effects in persons who were opioid dependent resulted in opioid withdrawal characterized by rapid onset of severe body aches, vomiting, diarrhea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.

In some patients, aggressive behavior has occurred in the context of abrupt reversal of an opioid overdose. In the neonate, opioid withdrawal signs and symptoms also included: convulsions, excessive crying, and hyperactive reflexes [ see Warnings and Precautions ( 5.3 ) ]. The following adverse reactions were most commonly observed in ZIMHI clinical studies: dizziness and injection site erythema.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact ZMI Pharma Corporation at 1-800-230-3935 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

👥 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 ) . Available data from retrospective cohort studies on naloxone use in pregnant women have not identified a drug-associated risk of major birth defects or miscarriage. In animal reproduction studies, no embryotoxic or teratogenic effects were observed in mice and rats treated with naloxone hydrochloride during the period of organogenesis at doses equivalent to 4-times and 8-times, respectively, a human dose of 10 mg/day.

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 ZIMHI for opioid overdose should not be withheld because of potential concerns regarding the effects of ZIMHI on the fetus. Data Animal Data Naloxone hydrochloride 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 hydrochloride.

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, the effects of naloxone on the breastfed infant, or on milk production. Studies in nursing mothers have shown that naloxone does not affect prolactin or oxytocin hormone levels.

8.4Pediatric Use The safety and effectiveness of ZIMHI ® (for intramuscular and subcutaneous use) have been established in pediatric patients of all ages for the emergency treatment of known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression. Use of naloxone hydrochloride in all pediatric patients is supported by adult bioequivalence studies coupled with evidence from the safe and effective use of another naloxone hydrochloride injectable product. No pediatric studies were conducted for ZIMHI.

Absorption of naloxone hydrochloride following subcutaneous or intramuscular administration in pediatric patients may be erratic or delayed. Even when the opiate-intoxicated pediatric patient responds appropriately to naloxone hydrochloride injection, he/she must be carefully monitored for at least 24 hours as a relapse may occur as naloxone is metabolized. In opioid-dependent pediatric patients, (including neonates), administration of naloxone hydrochloride may result in an abrupt and complete reversal of opioid effects, precipitating an acute opioid withdrawal syndrome.

There may be clinical settings, particularly the postpartum period in neonates with known or suspected exposure to maternal opioid use, where it is preferable to avoid the abrupt precipitation of opioid withdrawal symptoms. Unlike acute opioid withdrawal in adults, acute opioid withdrawal in neonates manifesting as seizures may be life-threatening if not recognized and properly treated. Other signs and symptoms in neonates may include excessive crying and hyperactive reflexes.

In these settings where it may be preferable to avoid the abrupt precipitation of acute opioid withdrawal symptoms, consider use of an alternative, naloxone hydrochloride product that can be dosed according to weight and titrated to effect. [ see Warnings and Precautions ( 5.3 ) ]. In pediatric patients under the age of one year, the caregiver should pinch the thigh muscle while administering ZIMHI. Carefully…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Life-sustaining therapy for opioid overdose should not be withheld ( see Clinical Considerations ) . Available data from retrospective cohort studies on naloxone use in pregnant women have not identified a drug-associated risk of major birth defects or miscarriage. In animal reproduction studies, no embryotoxic or teratogenic effects were observed in mice and rats treated with naloxone hydrochloride during the period of organogenesis at doses equivalent to 4-times and 8-times, respectively, a human dose of 10 mg/day.

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 ZIMHI for opioid overdose should not be withheld because of potential concerns regarding the effects of ZIMHI on the fetus. Data Animal Data Naloxone hydrochloride 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 hydrochloride.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of ZIMHI ® (for intramuscular and subcutaneous use) have been established in pediatric patients of all ages for the emergency treatment of known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression. Use of naloxone hydrochloride in all pediatric patients is supported by adult bioequivalence studies coupled with evidence from the safe and effective use of another naloxone hydrochloride injectable product. No pediatric studies were conducted for ZIMHI.

Absorption of naloxone hydrochloride following subcutaneous or intramuscular administration in pediatric patients may be erratic or delayed. Even when the opiate-intoxicated pediatric patient responds appropriately to naloxone hydrochloride injection, he/she must be carefully monitored for at least 24 hours as a relapse may occur as naloxone is metabolized. In opioid-dependent pediatric patients, (including neonates), administration of naloxone hydrochloride may result in an abrupt and complete reversal of opioid effects, precipitating an acute opioid withdrawal syndrome.

There may be clinical settings, particularly the postpartum period in neonates with known or suspected exposure to maternal opioid use, where it is preferable to avoid the abrupt precipitation of opioid withdrawal symptoms. Unlike acute opioid withdrawal in adults, acute opioid withdrawal in neonates manifesting as seizures may be life-threatening if not recognized and properly treated. Other signs and symptoms in neonates may include excessive crying and hyperactive reflexes.

In these settings where it may be preferable to avoid the abrupt precipitation of acute opioid withdrawal symptoms, consider use of an alternative, naloxone hydrochloride product that can be dosed according to weight and titrated to effect. [ see Warnings and Precautions ( 5.3 ) ]. In pediatric patients under the age of one year, the caregiver should pinch the thigh muscle while administering ZIMHI. Carefully observe the administration site for evidence of residual needle parts, signs of infection, or both. [ see Dosing Information ( 2.2 ) ].

🧓 Geriatric Use 77 words ▾

8.5Geriatric Use 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 studies of naloxone hydrochloride 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.

🧬 Clinical Pharmacology ~2 min read ▾

12. CLINICAL PHARMACOLOGY

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

12.3Pharmacokinetics In a pharmacokinetic study of 14 healthy adults, a single intramuscular injection of 5 mg ZIMHI in a single-dose pre-filled syringe in a delivery device provides significantly higher C max and AUC compared to a single intramuscular injection of 2 mg naloxone hydrochloride (1mg /1mL). Naloxone plasma concentration versus time profiles are shown in Figure 1. The pharmacokinetic parameters of naloxone in plasma are shown in Table 1.

Table 1: Mean Pharmacokinetic Parameters (CV%) for Naloxone Following a Single Intramuscular Injection of 5 mg ZIMHI ® ( n aloxone HCl) and a Single Intramuscular Injection of 2 mg Naloxone HCl in Healthy Subjects Parameter Intramuscular Injection of 5 mg ZIMHI (N = 14) Intramuscular Injection of 2 mg Naloxone HCl (N = 14) T max (h)* 0.25 (0.17, 0.52) 0.25 (0.05, 3.00) C max (ng/mL) 17.2 (44) 3.58 (58.1) AUC 0-t (ng.h/mL) 26.2 (21.5) 9.43 (23.8) AUC 0-inf (ng.h/mL) 26.6 (21.2) 9.97 (22.6) AUC 0-0.04h (ng.h/mL) 0.02 (208) 0.01 (164) AUC 0-0.08h (ng.h/mL) 0.15 (117) 0.04 (128) T 1/2 (h) 1.50 (15.2) 1.86 (28.9) *t max reported as median (minimum, maximum) Figure 1 Mean ± SD Plasma Concentration of Naloxone, (a) 0- 30 min and (b) 0-12 h Following a Single Intramuscular Administration of 5 mg ZIMHI and a Single Intramuscular Administration of 2 mg Naloxone HCl a) b) 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 Following a single 5 mg/0.5 mL mg ZIMHI injection, the mean plasma half-life of naloxone in healthy adults was 1.50 hours with values for individual subjects ranging from 1.18 to 1.87 hours. In a neonatal study of naloxone injection, the mean (± SD) plasma half-life was observed to be 3.1 (± 0.5) hours. Metabolism Naloxone hydrochloride 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. Figure 1 Mean ± SD Plasma Concentration of Naloxone, (a) 0-30 min and (b) 0-12 h Following a Single Intramuscular Administration of 5 mg ZIMHI and a Single Intramuscular Administration of 2 mg Naloxo Mean ± SD Plasma Concentration of Naloxone, (a) 0-1 h and (b) 0-12 h Following Intramuscular/Subcutaneous Administration Using ZIMHITM

🧬 Mechanism of Action 48 words ▾

12.1Mechanism of Action Naloxone hydrochloride is an opioid antagonist that antagonizes opioid effects by competing for the same receptor sites. Naloxone hydrochloride 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 ~1 min read ▾

16. HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied ZIMHI (naloxone hydrochloride injection, USP) 5 mg/0.5 mL is a clear, colorless to slightly yellow, sterile solution provided as follows: NDC 84571 -140-11: Carton containing one case which contains one 5 mg/0.5 mL single-dose, pre-filled syringe NDC 84571-140 -02 : Carton containing two cases, each of which contain one 5 mg/0.5 mL single-dose, pre-filled syringe per case NDC 84571 - 140 - 1 1 : Case containing one 5 mg/0.5 mL single-dose, pre-filled syringe

16.2Storage and Handling Store ZIMHI in the outer case provided. Store below 77 o F (25 o C). Excursions permitted up to 104 o F (40 o C).

Do Not freeze or expose to excessive heat above 104 o F (40 o C). Protect from light. Prior to a medical emergency (during storage), periodically visually inspect ZIMHI through the viewing window on the device.

If the solution is discolored yellow or brown color, cloudy, or contains particles, replace ZIMHI with a new one.

16.1How Supplied ZIMHI (naloxone hydrochloride injection, USP) 5 mg/0.5 mL is a clear, colorless to slightly yellow, sterile solution provided as follows: NDC 84571 -140-11: Carton containing one case which contains one 5 mg/0.5 mL single-dose, pre-filled syringe NDC 84571-140 -02 : Carton containing two cases, each of which contain one 5 mg/0.5 mL single-dose, pre-filled syringe per case NDC 84571 - 140 - 1 1 : Case containing one 5 mg/0.5 mL single-dose, pre-filled syringe

📦 Storage and Handling 84 words ▾

16.2Storage and Handling Store ZIMHI in the outer case provided. Store below 77 o F (25 o C). Excursions permitted up to 104 o F (40 o C).

Do Not freeze or expose to excessive heat above 104 o F (40 o C). Protect from light. Prior to a medical emergency (during storage), periodically visually inspect ZIMHI through the viewing window on the device.

If the solution is discolored yellow or brown color, cloudy, or contains particles, replace ZIMHI with a new one.

📋 Description 113 words ▾

11. DESCRIPTION ZIMHI (naloxone hydrochloride injection, USP) is an opioid antagonist supplied in a single-dose pre-filled syringe. ZIMHI is not made with natural rubber latex.

Chemically, naloxone hydrochloride 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 • HCl 399.9 g/mol 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. Each 0.5 mL contains 5 mg naloxone hydrochloride (equivalent to 4.5 mg naloxone), 4.17 mg sodium chloride, hydrochloric acid to adjust pH, and water for injection.

Structural formula for naloxone hydrochloride

💬 Information for Patients ~3 min read ▾

17. PATIENT COUNSELING INFORMATION Advise the patient and family members or caregivers to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Instruct patients and their family members or caregivers to become familiar with all information contained in the case and carton as soon as they receive ZIMHI.

Inform patients of the following: ZIMHI is for the emergency treatment of known or suspected overdose. It is administered by a caregiver according to the Instructions for Use. After administration, the caregiver should get emergency help immediately.

Recognition of Opioid Overdose Instruct the patients and their family members or caregivers how to recognize the signs and symptoms of an opioid overdose requiring the use of ZIMHI ® such as the following: Extreme somnolence - inability to awaken a patient verbally or upon a firm sternal rub. Respiratory depression - this can range from slow or shallow respiration to no respiration in a patient who is unarousable. Other signs and symptoms that may accompany somnolence and respiratory depression include the following: Miosis.

Bradycardia and/or hypotension. Risk of Recurrent Respiratory and Central Nervous System Depression Instruct patients and their family members or caregivers that, because the duration of action of most opioids may exceed that of ZIMHI, they must seek immediate emergency medical assistance after the first dose of ZIMHI and keep the patient under continued surveillance [ see Dosage and Administration ( 2.2 ) , Warnings and Precautions ( 5.3 ) ]. Limited Efficacy for/with Partial Agonists or Mixed Agonist/Antagonists Instruct patients and their family members or caregivers that the reversal of respiratory depression caused by partial agonists or mixed agonist/antagonists such as buprenorphine and pentazocine, may be incomplete and may require higher doses of naloxone hydrochloride or repeated administration of ZIMHI [ see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.3 ) ].

Precipitation of Severe Opioid Withdrawal Instruct patients and their family members or caregivers that the use of ZIMHI in patients who are opioid dependent may precipitate an acute abstinence syndrome characterized by the following signs and symptoms: 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 neonates, opioid withdrawal may be life threatening if not recognized and properly treated and may include the following signs and symptoms: convulsions, excessive crying, and hyperactive reflexes [ see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6 ) ].

Administration Instructions Instruct patients and their family members or caregivers to carefully read the Instructions for Use before an emergency arises. Emphasize the following important information: ZIMHI is intended to be administered by individuals 12 years of age or older. Younger individuals or those with limited hand strength may find the device difficult to use.

Each syringe is for a single-dose injection. Make sure ZIMHI is present whenever persons may be intentionally or accidentally exposed to an opioid to treat serious opioid overdose (i.e., opioid emergencies). Administer ZIMHI as quickly as possible if a patient is unresponsive and an opioid overdose is suspected, even when in doubt, because prolonged respiratory depression may result in damage to the central nervous system or death.

ZIMHI is not a substitute for emergency medical care [ see Dosage and Administration ( 2.1 ) ]. When removing the needle cap, there may be a drop of liquid on the needle: this is normal. The device contains an excess of liquid to ensure the required dose is delivered.

Place the patient in the supine position. Inject ZIMHI into the anterolateral aspect of the thigh (through clothing, if necessary). I…

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