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Naloxone Hydrochloride 4 mg/.1mL Spray, 2 vials — NDC 69238-2104-07 package photo

Naloxone Hydrochloride 4 mg/.1mL Spray, 2 vials

by Amneal Pharmaceuticals LLC · 2 VIAL, SINGLE-DOSE in 1 CARTON (69238-2104-7) / .1 mL in 1 VIAL, SINGLE-DOSE (69238-2104-1)
NDC 69238-2104-07
🏷️ FDA NDC (as labeled) 69238-2104-7 billing pads the package segment with a zero
OTC Generic On market Non-controlled
🗂️ Data synced Sep 10, 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) 69238-2104-7
Product NDC 69238-2104
11-digit billing NDC 69238210407
NCPDP billing unit EA — each (per item)
RxCUI 1725059
UNII F850569PQR
UPC 0369238210477
Application # ANDA217992
SPL Set ID 8091a73d-9ecd-4578-a57b-5d85a2c5a16a
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 2024-04-24
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 NALOXONE HCL 4 MG NASAL SPRAY
FDB brand name Naloxone Hcl
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 69238-2104-7 — a 5-4-1 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 package segment → 69238-2104-07. 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

LabelerAmneal Pharmaceuticals LLC
Application holderAMNEAL PHARMACEUTICALS LLC
FDA applicationANDA217992 (ANDA)
Labeler code69238
First marketedApr 2024
Product typeHuman Otc Drug
Portfolio472 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 NALOXONE HCL 4 MG NASAL SPRAY Ingredient Naloxone Hcl
📖 What it is MedlinePlus · NLM

Prescription and nonprescription (over the counter) naloxone nasal spray is used along with emergency medical treatment to reverse the life-threatening effects of a known or suspected opiate (narcotic) overdose in adults and children. Naloxone nasal spray is in a class of medications called opiate antagonists. It works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • 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

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.

💊 What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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, disodium ethylenediaminetetraacetate, hydrochloric acid, purified water, and sodium chloride

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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $16.922 $33.84 / 2 vials
Medicaid paysCMS SDUD · 12 mo $37.21 $74.41 / 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
Nov 2025 Apr 2026 Jun 2026 Aug 2026 $16.922 $15.225
▲ Up 10% over the last 6 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/.1mL 69547-0627-02 Emergent 2 vials $16.680 — Availability likely save 1%
Naloxone Hydrochloride 4 mg/.1mL 00480-3478-68 Teva 1 vial $16.922 — Availability likely —
Naloxone Hydrochloride 4 mg/.1mL 45802-0578-84 Padagis 2 vials $16.922 — Availability likely —
Naloxone Hydrochloride 4 mg/.1mL 46122-0812-71 AMERISOURCE 2 vials $16.922 — Availability likely —
Naloxone Hydrochloride 4 mg/.1mL 60219-2104-07 Amneal 2 vials $16.922 — Availability likely —
Naloxone Hydrochloride 4 mg/.1mL 68001-0645-45 BluePoint 2 vials $16.922 — Availability likely —
Naloxone Hydrochloride 4 mg/.1mLthis 69238-2104-07 Amneal 2 vials $16.922 — Availability likely —
Naloxone Hydrochloride 4 mg/.1mL 70677-1283-01 Strategic 2 vials $16.922 — Availability likely —
Naloxone Hydrochloride 4 mg/.1mL 00093-2165-68 Teva 1 vial $34.270 — Discontinued +103%
Narcan 4 mg/.1mL 69547-0353-02 Emergent 2 vials $59.869 — Discontinued +254%
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 —
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

🏛️
2024
On the market since
Apr 2024
📍
2026
Currently FDA-listed
2 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.

🗺️ 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 69238-2104-07, 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 – Q4 2025 · 4 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
3.7K
Units reimbursed last 4 qtrs
5.9K
Gross reimbursed last 4 qtrs
$218.4K
Avg / prescription
$59.70
Avg / unit
$37.2080
Latest quarter Q4 2025
888Rx
Medicaid pays / ea
$37.2080
gross reimbursed
vs
NADAC / ea
$16.9224
acquisition cost
=
Spread
+$20.2856
+120% 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 ⓘ
17% FFS 83% MCO
Fee-for-service · 624 Rx Managed care · 3,035 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 268 units · 3.4 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 31 units · 0.3 per 100k residents MI New York: 123 units · 0.6 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 54 units · 1.3 per 100k residents OR Nevada: 40 units · 1.3 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 110 units · 1.6 per 100k residents IN Ohio: 360 units · 3.1 per 100k residents OH Pennsylvania: 2,238 units · 17.3 per 100k residents PA New Jersey: 757 units · 8.1 per 100k residents NJ Massachusetts: no data reported MA California: 264 units · 0.7 per 100k residents CA Utah: 160 units · 4.7 per 100k residents UT Colorado: 194 units · 3.3 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 364 units · 8.0 per 100k residents KY West Virginia: no data reported WV Virginia: 145 units · 1.7 per 100k residents VA Maryland: 360 units · 5.8 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 36 units · 0.5 per 100k residents AZ New Mexico: 24 units · 1.1 per 100k residents NM Kansas: 30 units · 1.0 per 100k residents KS Arkansas: no data reported AR Tennessee: 30 units · 0.4 per 100k residents TN North Carolina: 52 units · 0.5 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 88 units · 2.2 per 100k residents OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 142 units · 0.5 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.317.3
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
🏆 Top states by units · per 100k residents
1 Pennsylvania 17.3 /100k
2 New Jersey 8.1 /100k
3 Kentucky 8.0 /100k
4 Maryland 5.8 /100k
5 Utah 4.7 /100k
6 Washington 3.4 /100k
7 Colorado 3.3 /100k
8 Ohio 3.1 /100k
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69238-2104-07 You're viewing this 2 VIAL, SINGLE-DOSE in 1 CARTON (69238-2104-7) / .1 mL in 1 VIAL, SINGLE-DOSE (69238-2104-1) 2024-04-24 Active

📄 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 ▾

Use(s) 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 206 words ▾

Directions 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 911 CALL 911 immediately after giving the 1st dose Step 4: WATCH & GIVE WAIT 2 to 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 to 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 1 check 2 give 3 call step 4 5 stay

⚠️ Warnings 27 words ▾

Warnings 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 13 words ▾

Inactive ingredients benzalkonium chloride, disodium ethylenediaminetetraacetate, hydrochloric acid, purified water, and sodium chloride

🎯 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 ↗
← 69238-2095-03 · Amneal 69238-2108-05 · Amneal →
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.