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NARCAN naloxone hydrochloride nasal 4 mg/.1mL Spray, 2 vials — NDC 69547-0627-05 package photo

NARCAN naloxone hydrochloride nasal 4 mg/.1mL Spray, 2 vials

by Emergent Devices Inc. · 1 CASE in 1 CARTON (69547-627-05) / 2 VIAL, SINGLE-DOSE in 1 CASE / .1 mL in 1 VIAL, SINGLE-DOSE
NDC 69547-0627-05
🏷️ FDA NDC (as labeled) 69547-627-05 billing pads the product segment with a zero
This package
Contains2 vials Cost per ea$16.45 NADAC Per package$32.90 / 2 vials Pack sizes4 compare ↓
Also comes in: 2 vials 69547-0627-02 6 vials 69547-0627-06 24 vials 69547-0627-24
OTC Brand On market Non-controlled
🗂️ Data synced Sep 3, 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) 69547-627-05
Product NDC 69547-627
11-digit billing NDC 69547062705
NCPDP billing unit EA — each (per item)
RxCUI 1725059, 1725064
UNII F850569PQR
Application # NDA208411
SPL Set ID a0ebc83d-2892-40de-bc0a-775ce90b30db
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 2023-08-28
Route NASAL
Dosage form SPRAY
Substance NALOXONE HYDROCHLORIDE
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 NARCAN 4 MG NASAL SPRAY
FDB brand name Narcan
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 69547-627-05 — 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 → 69547-0627-05. 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

LabelerEmergent Devices Inc.
Application holderEMERGENT OPERATIONS IRELAND LTD
FDA applicationNDA208411 (NDA)
Labeler code69547
First marketedAug 2023
Product typeHuman Otc Drug
Portfolio2 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name NARCAN 4 MG NASAL SPRAY Ingredient Naloxone Hcl
📗 Our plain-language guide HelloPharmacist
  • Naloxone is an emergency medicine that rapidly reverses the effects of an opioid overdose — things like very slow or stopped breathing, extreme drowsiness, or unconsciousness. You...
  • What exactly does naloxone do, and when should I use it?
  • Give one spray into one nostril. The device is ready to use — no assembly needed for most products like Narcan or Kloxxado. If the person doesn't improve within 2 to 3 minutes, giv...
  • How do I actually use the nasal spray, and what if it doesn't seem to work?
📖 Read our full Naloxone guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $16.449 $32.90 / 2 vials
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.
NADAC price history (per ea) — tap or hover for the price & month
Jun 2026 Jul 2026 Aug 2026 Sep 2026 $17.313 $16.449
▼ Down 5% over the last 4 months.
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
Narcan 4 mg/.1mLthis 69547-0627-05 Emergent 2 vials $16.449 — Availability likely —
Naloxone Hydrochloride 4 mg/.1mL 00480-3478-68 Teva 1 vial $17.177 — Availability likely +4%
Naloxone Hydrochloride 4 mg/.1mL 45802-0578-84 Padagis 2 vials $17.177 — Availability likely +4%
Naloxone Hydrochloride 4 mg/.1mL 46122-0812-71 AMERISOURCE 2 vials $17.177 — Availability likely +4%
Naloxone Hydrochloride 4 mg/.1mL 60219-2104-07 Amneal 2 vials $17.177 — Availability likely +4%
Naloxone Hydrochloride 4 mg/.1mL 68001-0645-45 BluePoint 2 vials $17.177 — Availability likely +4%
Naloxone Hydrochloride 4 mg/.1mL 69238-2104-07 Amneal 2 vials $17.177 — Availability likely +4%
Naloxone Hydrochloride 4 mg/.1mL 70677-1283-01 Strategic 2 vials $17.177 — Availability likely +4%
Naloxone Hydrochloride 4 mg/.1mL 00093-2165-68 Teva 1 vial $34.270 — Discontinued +108%
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 —
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 —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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
Aug 2023
📍
2026
Currently FDA-listed
3 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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.

💊 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 vials69547-0627-02 109,601 Rx · $5,733,013
2 vials this page69547-0627-05 No Medicaid data
6 vials69547-0627-06 No Medicaid data
24 vials69547-0627-24 No Medicaid data
Drug total (last 4 qtrs): 109,601 Rx · 24,389 units · $5,733,013 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Narcan — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Narcan. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$71K
Claims incl. refills
660
Beneficiaries
628
Spend / beneficiary
$113.00
Spend / claim
$107.52
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
69547-0627-02 2 VIAL, SINGLE-DOSE in 1 CARTON (69547-627-02) / .1 mL in 1 VIAL, SINGLE-DOSE $16.45 / ea $32.90 2023-08-28 Active
69547-0627-05 You're viewing this 1 CASE in 1 CARTON (69547-627-05) / 2 VIAL, SINGLE-DOSE in 1 CASE / .1 mL in 1 VIAL, SINGLE-DOSE $16.45 / ea $32.90 2026-03-15 Active
69547-0627-06 6 VIAL, SINGLE-DOSE in 1 CARTON (69547-627-06) / .1 mL in 1 VIAL, SINGLE-DOSE — — 2026-03-15 Active
69547-0627-24 24 VIAL, SINGLE-DOSE in 1 CARTON (69547-627-24) / .1 mL in 1 VIAL, SINGLE-DOSE — — 2026-03-15 Active

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($16.45 NADAC).

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 NDC 69547-0627-05?
NDC 69547-0627-05 contains 2 vials — 1 case in 1 carton / 2 vial, single-dose in 1 case / .1 ml in 1 vial, single-dose.
What is the difference between NDC 69547-0627-05 and NDC 69547-0627-02?
Both are NARCAN naloxone hydrochloride nasal 4 mg/.1mL Spray — the drug itself is identical. NDC 69547-0627-05 is the 2 vials package, while NDC 69547-0627-02 is the 2 vials package.
What NDC number is used to bill for this package of NARCAN naloxone hydrochloride nasal 4 mg/.1mL Spray?
Bill NDC 69547-0627-05 — the 11-digit billing format is 69547062705. 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.

📄 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
🎯 Indications and Usage 24 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 ~2 min read ▾

Directions NARCAN ® Naloxone HCl Nasal Spray 4 mg 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 1 st 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 911 CALL 911 immediately after giving the l st dose Step 4: WATCH & GIVE WAIT 2-3 minutes after the l st 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 NARCAN, call 1-844-4NARCAN (1-844-462-7226) or go to www.narcan.com . ©2023 Emergent Devices Inc. EMERGENT® and NARCAN® are registered trademarks of Emergent BioSolutions Inc, or its subsidiaries. Other Information store at room temperature or refrigerated, between 2°C to 25°C (36°F to 77°F) do not freeze avoid excessive heat above 40°C (104°F) protect from light the product is packaged in individually-sealed blisters.

Do not use if the blister is open or torn, or if the device appears damaged. Naloxone HCl Nasal Spray 4 mg 1. Check 2.

Give 3. Call 4. Watch/Give 5.

Stay

⚠️ 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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 69547-0353-02 · Emergent 69548-0417-01 · Aspen →
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.