NARCAN naloxone hydrochloride nasal 4 mg/.1mL Spray, 2 vials
by Emergent Devices Inc. · 2 VIAL, SINGLE-DOSE in 1 CARTON (69547-627-02) / .1 mL in 1 VIAL, SINGLE-DOSE
NDC 69547-0627-02
🏷️ FDA NDC (as labeled)
69547-627-02
billing pads the product segment with a zero
This package
Also priced by: Medicaid pays $235.07/unit — full pricing hub ↓
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 →
🆔 Identity & classification
FDA NDC (as labeled)
69547-627-02
Product NDC
69547-627
11-digit billing NDC
69547062702
NCPDP billing unit
EA — each (per item)
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 69547-627-02 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 69547-0627-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
🏷️ RxNorm drug class
This medicine belongs to the Opioid Antagonist class.
Pharmacologic class
Opioid Antagonist
Drug family (ATC)
Other opioids, Natural opium alkaloids, Benzomorphan derivatives
How it works
Opioid Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
🏭 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?
Patient education
Supplement & herbal interactions
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.
💬 Questions about naloxone hydrochloride nasal?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
💲 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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $16.449 | $32.90 / 2 vials |
| Medicaid paysCMS SDUD · 12 mo | $235.07 | $470.13 / 2 vials |
| 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
▼ Down 20% over the last 11 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Narcan 4 mg/.1mLthis 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 | +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 & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 69547-0627-02, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
109.6K
Units reimbursed last 4 qtrs
24.4K
Gross reimbursed last 4 qtrs
$5.73M
Avg / prescription
$52.31
Avg / unit
$235.06
Latest quarter Q1 2026
25.9KRx
Medicaid pays / ea
$235.06
gross reimbursed
vs
NADAC / ea
$16.4490
acquisition cost
=
Spread
+$218.61
+1329% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
Fee-for-service · 86,675 Rx Managed care · 22,926 Rx
State Medicaid map
Units reimbursed · per 100k residents
0.176.1
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
💊 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.
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 NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 69547-0627-02 You're viewing this | 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 | 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 has the lowest per-ea cost of the 2 priced pack sizes ($16.45 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 69547-0627-02?
NDC 69547-0627-02 contains 2 vials — 2 vial, single-dose in 1 carton / .1 ml in 1 vial, single-dose.
What is the difference between NDC 69547-0627-02 and NDC 69547-0627-05?
Both are NARCAN naloxone hydrochloride nasal 4 mg/.1mL Spray — the drug itself is identical. NDC 69547-0627-02 is the 2 vials package, while NDC 69547-0627-05 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 69547-0627-02 — the 11-digit billing format is 69547062702. 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 ▾
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 ▾
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 ▾
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 ▾
Active ingredient (in each spray) Naloxone Hydrochloride 4 mg
🧪 Inactive Ingredients ▾
Inactive Ingredients benzalkonium chloride, edetate disodium, hydrochloric acid, sodium chloride, water
🎯 Purpose ▾
Purpose Emergency treatment of opioid overdose
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.