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NALOXONE HYDROCHLORIDE 4 mg/.1mL Spray, 24 vials — NDC 45802-0578-24 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

NALOXONE HYDROCHLORIDE 4 mg/.1mL Spray, 24 vials — NDC 45802-578-24 (Billing 45802-0578-24)

by Padagis Israel Pharmaceuticals Ltd · 24 VIAL, SINGLE-DOSE in 1 CARTON / .1 mL in 1 VIAL, SINGLE-DOSE

This is a package of 24 vials of NALOXONE HYDROCHLORIDE 4 mg/.1mL Spray from Padagis Israel Pharmaceuticals Ltd, marketed since Jul 2023 and currently FDA-listed.

NDC 45802-0578-24
🏷️ FDA NDC (as labeled) 45802-578-24 billing pads the product segment with a zero
This package
Contains24 vials Pack sizes2 compare ↓
Product page 45802-0578-84 Also comes in: 2 vials 45802-578-84
OTC Generic 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 45802-578-24 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
45802 labeler · 578 product · 24 package
Package marketed since
Aug 1, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
24 EA per package
Barcode (UPC-A, from the NDC)
3 4580257824 2
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 45802-578-24
Product NDC 45802-578
11-digit billing NDC 45802057824
NCPDP billing unit EA — each (per item)
RxCUI 1725059
UNII F850569PQR
Application # ANDA211951
SPL Set ID b5d40220-f194-4835-b70c-f304ecb222d5
Established class (EPC) Opioid Antagonist
Mechanism of action Opioid Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-07-30
Route NASAL
Dosage form SPRAY
Substance NALOXONE HYDROCHLORIDE

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

GPI-14 93400020100920
GCN Seq No 075222
GCN 40233
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 HCL 4 MG NASAL SPRAY
FDB brand name Naloxone Hcl
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 075222
  • GCN: 40233
  • GPI-14 (Medi-Span): 93400020100920
  • HICL (First Databank): 001874
  • AHFS class code: 28:10.00.00
  • RxCUI (RxNorm): 1725059
Why two NDCs? The FDA registers this code as 45802-578-24 — 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 → 45802-0578-24. 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 HCL 4 MG NASAL SPRAY Ingredient Naloxone Hcl
📗 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.
Try another pack size: 2 vials
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 Per unit Per pack Marketing startMarketing endStatus
45802-0578-84 45802-578-84 Main listing 2 VIAL, SINGLE-DOSE in 1 CARTON / .1 mL in 1 VIAL, SINGLE-DOSE $17.18 / ea $34.35 2023-07-30 — Active
45802-0578-24 You're viewing this 24 VIAL, SINGLE-DOSE in 1 CARTON / .1 mL in 1 VIAL, SINGLE-DOSE — — 2025-08-01 — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 24 vials — 24 vial, single-dose in 1 carton / .1 ml in 1 vial, single-dose.
How does this package differ from NDC 45802-0578-84?
Both are NALOXONE HYDROCHLORIDE 4 mg/.1mL Spray — the drug itself is identical. This page's package is the 24 vials one, while NDC 45802-0578-84 is the 2 vials package.
What NDC number is used to bill for this package of NALOXONE HYDROCHLORIDE 4 mg/.1mL Spray?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Narcan 4 mg/.1mL 69547-0627-02 Emergent 2 vials $16.449 — Availability likely —
Naloxone Hydrochloride 4 mg/.1mL 00480-3478-68 Teva 1 vial $17.177 — Availability likely —
Naloxone Hydrochloride 4 mg/.1mL 46122-0812-71 AMERISOURCE 2 vials $17.177 — Availability likely —
Naloxone Hydrochloride 4 mg/.1mL 60219-2104-07 Amneal 2 vials $17.177 — Availability likely —
Naloxone Hydrochloride 4 mg/.1mL 68001-0645-45 BluePoint 2 vials $17.177 — Availability likely —
Naloxone Hydrochloride 4 mg/.1mL 69238-2104-07 Amneal 2 vials $17.177 — Availability likely —
Naloxone Hydrochloride 4 mg/.1mL 70677-1283-01 Strategic 2 vials $17.177 — Availability likely —
Naloxone Hydrochloride 4 mg/.1mL 00093-2165-68 Teva 1 vial $34.270 — Discontinued —
Narcan 4 mg/.1mL 69547-0353-02 Emergent 2 vials $59.869 — Discontinued —
Naloxone Hydrochloride 4 mg/.1mL 00363-2140-02 Walgreen 2 vials — — FDA listed —
Naloxone Hydrochloride 4 mg/.1mL 00591-3871-99 Actavis 1 vial — — FDA listed —
Naloxone Hydrochloride 4 mg/.1mL 42291-0493-02 AvKARE 2 vials — — FDA listed —
Naloxone Hydrochloride 4 mg/.1mLthis 45802-0578-24 Padagis 24 vials — — FDA listed —
Narcan 4 mg/.1mL 50090-2422-00 A-S 2 vials — — FDA listed —
Naloxone Hydrochloride 4 mg/.1mL 50090-5908-00 A-S 2 vials — — FDA listed —
Naloxone Hydrochloride 4 mg/.1mL 50090-6710-00 A-S 2 vials — — FDA listed —
Naloxone Hydrochloride 4 mg/.1mL 50090-6963-00 A-S 2 vials — — FDA listed —
Naloxone Hydrochloride 4 mg/.1mL 51316-0210-02 CVS 2 vials — — FDA listed —
Narcan Naloxone Hci 4 mg/.1mL 51662-1240-01 HF 1 ml — — FDA listed —
NALOXONE HCl 4 mg/.1mL 51662-1620-01 HF 1 ml — — FDA listed —
Naloxone Hydrochloride 4 mg/.1mL 51662-1659-02 HF 2 vials — — FDA listed —
Naloxone Hydrochloride 4 mg/.1mL 67296-1928-02 Redpharm 1 vial — — Discontinued —
Narcan 4 mg/.1mL 71205-0528-02 Proficient 2 vials — — FDA listed —
Naloxone Hydrochloride 4 mg/.1mL 71205-0707-02 Proficient 2 vials — — FDA listed —
Naloxone Hydrochloride 4 mg/.1mL 72162-2376-02 Bryant 2 vials — — FDA listed —
Naloxone Hydrochloride 4 mg/.1mL 76420-0867-02 Asclemed 1 vial — — FDA listed —
Naloxone Hydrochloride 4 mg/.1mL 80425-0409-01 Advanced 2 vials — — FDA listed —
Narcan 4 mg/.1mL 85766-0076-02 Sportpharm 2 vials — — FDA listed —
Naloxone Hydrochloride 4 mg/.1mL 85766-0228-02 Sportpharm 1 vial — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
On the market since
Jul 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

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 F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 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.
  • 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.

5 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesbenzalkonium chloride, edetate disodium, hydrochloric acid, sodium chloride, water

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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.

Manufacturer & labeler

LabelerPadagis Israel Pharmaceuticals Ltd
Application holderPADAGIS ISRAEL PHARMACEUTICALS LTD
FDA applicationANDA211951 (ANDA)
Labeler code45802
First marketedJul 2023
Product typeHuman Otc Drug
Portfolio175 products on file

More NDCs from Padagis Israel Pharmaceuticals Ltd labeler code 45802

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 26 words ▾

Uses • to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin • this medicine can save a life

⏱️ Dosage and Administration ~1 min read ▾

Directions EMERGENCY TREATMENT OF OPIOID OVERDOSE Important: • For use in the nose only • Do not test nasal spray device before use • 1 nasal spray device contains 1 dose of medicine • Each device sprays 1 time only Step 1: CHECK if you suspect an overdose: • CHECK for a suspected overdose : the person will not wake up or is very sleepy or not breathing well • yell “Wake up!” • shake the person gently • if the person is not awake, go to Step 2 Step 2: GIVE 1st dose in the nose • HOLD the nasal spray device with your thumb on the bottom of the plunger • INSERT the nozzle into either NOSTRIL • PRESS the plunger firmly to give the 1st dose • 1 nasal spray device contains 1 dose Step 3: CALL • CALL 911 immediately after giving the 1st dose Step 4: WATCH & GIVE • WAIT 2-3 minutes after the 1st dose to give the medicine time to work • if the person wakes up : Go to Step 5 • if the person does not wake up : • CONTINUE TO GIVE doses every 2-3 minutes until the person wakes up • it is safe to keep giving doses Step 5: STAY • STAY until ambulance arrives: even if the person wakes up • GIVE another dose if the person becomes very sleepy again • You may need to give all the doses in the pack For opioid emergencies, call 911 .

For questions on Naloxone HCl Nasal Spray 4 mg, call Padagis ® at 1-866-634-9120 or go to www.padagisnaloxone.com. Step 1 Step 2 Step 3 Step 4 Step 5

⚠️ Warnings 27 words ▾

Warning When using this product some people may experience symptoms when they wake up, such as shaking, sweating, nausea, or feeling angry. This is to be expected.

🧪 Active Ingredient 9 words ▾

Active Ingredient (in each spray) Naloxone hydrochloride 4 mg

🧪 Inactive Ingredients 11 words ▾

Inactive Ingredients benzalkonium chloride, edetate disodium, hydrochloric acid, sodium chloride, water

🎯 Purpose 6 words ▾

Purpose Emergency treatment of opioid overdose

📄 Package Label / Principal Display Panel 111 words ▾

Package/Label Principal Display Panel NDC 45802-578-84 Compare to NARCAN ® active ingredient Padagis Naloxone Naloxone HCl Nasal Spray 4 mg Emergency Treatment of Opioid Overdose Original Prescription Strength Easy to Use Can Save a Life Designed to Rapidly Reverse the Effects of a Life-Threatening Opioid Emergency 2 SINGLE-DOSE NASAL SPRAY DEVICES 0.003 FL OZ (0.1mL) EACH FOR USE IN NOSE ONLY DO NOT TEST NASAL SPRAY DEVICE BEFORE USE 1 NASAL SPRAY DEVICE CONTAINS 1 DOSE OF MEDICINE EACH DEVICE SPRAYS 1 TIME ONLY SAFE TO USE EVEN IF OPIOIDS ARE NOT PRESENT Distributed by Padagis ® Allegan, MI 49010 www.padagisnaloxone.com 64QJ8 RT C4 Product of USA 64Q00 RT QS5 carton

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
2 vials45802-0578-84 495,347 Rx · $25,084,115
24 vials this page45802-0578-24 No Medicaid data
Drug total (last 4 qtrs): 495,347 Rx · 115,628 units · $25,084,115 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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 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 Padagis Israel Pharmaceuticals Ltd. 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 2 vials (45802-0578-84). 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?
Padagis Israel Pharmaceuticals Ltd 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.
← 45802-0573-30 · Padagis 45802-0580-01 · Padagis →
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.