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Naloxone Hydrochloride 4 mg/.1mL Spray, Metered — NDC 00480-3478-68 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, Metered — NDC 0480-3478-68 (Billing 00480-3478-68)

by Teva Pharmaceuticals, Inc. · 2 BLISTER PACK in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE

This is a package of Naloxone Hydrochloride 4 mg/.1mL Spray, Metered from Teva Pharmaceuticals, Inc., marketed since Sep 2024 and currently FDA-listed; retail pharmacies pay about $17.18 per unit (NADAC). It is this product's only package size.

NDC 00480-3478-68
🏷️ FDA NDC (as labeled) 0480-3478-68 billing pads the labeler segment with a zero
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 0480-3478-68 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0480 labeler · 3478 product · 68 package
Package marketed since
Sep 23, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0480347868 5
Medicaid fills, this package
262,312 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0480-3478-68
Product NDC 0480-3478
11-digit billing NDC 00480347868
NCPDP billing unit EA — each (per item)
RxCUI 1725059
UNII F850569PQR
Application # ANDA209522
SPL Set ID 3a73ee4b-c2a4-496f-be90-9f78c8046062
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 2024-09-23
Route NASAL
Dosage form SPRAY, METERED
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 0480-3478-68 — a 4-4-2 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 labeler segment → 00480-3478-68. 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
📖 What it is MedlinePlus · NLM

Naloxone nasal spray is used along with emergency medical treatment to reverse the life-threatening effects of a known or suspected opiate (narcotic) overdose. 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
  • 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 eaPer package
Retail pharmacies payNADAC · weekly $17.177 $34.35 / 2 vials
Medicaid paysCMS SDUD · 12 mo $112.41 $224.82 / 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 May 2026 Jul 2026 Sep 2026 $17.177 $15.225
▲ Up 11% over the last 7 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00480-3478-68 You're viewing this Main listing 2 BLISTER PACK in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE 2024-09-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Narcan 4 mg/.1mL 69547-0627-02 Emergent 2 vials $16.449 — Availability likely save 4%
Naloxone Hydrochloride 4 mg/.1mLthis 00480-3478-68 Teva 1 vial $17.177 — Availability likely —
Naloxone Hydrochloride 4 mg/.1mL 45802-0578-84 Padagis 2 vials $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 +100%
Narcan 4 mg/.1mL 69547-0353-02 Emergent 2 vials $59.869 — Discontinued +249%
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
Sep 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.

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, sodium chloride buffered with sodium hydroxide/hydrochloric acid, 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

LabelerTeva Pharmaceuticals, Inc.
Application holderTEVA PHARMACEUTICALS USA INC
FDA applicationANDA209522 (ANDA)
Labeler code00480
First marketedSep 2024
Product typeHuman Otc Drug
Portfolio166 products on file

More NDCs from Teva Pharmaceuticals, Inc. labeler code 00480

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 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 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 202 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 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 1 st dose 1 nasal spray device contains 1 dose Step 3: CALL CALL 911 immediately after giving the 1 st dose Step 4: WATCH & GIVE WAIT 2-3 minutes after the 1 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 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 14 words ▾

Inactive Ingredients benzalkonium chloride, edetate disodium, sodium chloride buffered with sodium hydroxide/hydrochloric acid, water

🎯 Purpose 6 words ▾

Purpose Emergency treatment of opioid overdose

📄 Other Information 41 words ▾

Other information Store below 77°F (25°C). 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.

📄 Questions or Comments 11 words ▾

Questions? 1-888-838-2872 between 9 am and 5 pm ET, Monday-Friday. www.tevausa.com/our-products/tevagenerics

📄 Package Label / Principal Display Panel 68 words ▾

Package/Label Principal Display Panel – Carton Label Original Prescription Strength Easy to Use Can Save a Life Compare to the active ingredient in NARCAN ®* NDC 0480-3478-68 Naloxone Hydrochloride Nasal Spray 4 mg Emergency Treatment of Opioid Overdose Designed to Rapidly Reverse the Effects of a Life-Threatening Opioid Emergency For use in nose only 2 Single-Dose Nasal Spray Devices 0.003 fl oz (0.1 mL) each 4 mg carton

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

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 this package alone, 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
262.3K
Units reimbursed last 4 qtrs
122.5K
Gross reimbursed last 4 qtrs
$13.77M
Avg / prescription
$52.51
Avg / unit
$112.41
Latest quarter Q1 2026
66.2KRx
Medicaid pays / ea
$112.41
gross reimbursed
vs
NADAC / ea
$17.1773
acquisition cost
=
Spread
+$95.2349
+554% 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 ⓘ
45% FFS 55% MCO
Fee-for-service · 116,915 Rx Managed care · 145,397 Rx
State Medicaid map
Alaska: 362 units · 49.4 per 100k residents AK Maine: no data reported ME Washington: 1,559 units · 20.0 per 100k residents WA Idaho: no data reported ID Montana: 110 units · 9.7 per 100k residents MT North Dakota: 6 units · 0.8 per 100k residents ND Minnesota: 535 units · 9.3 per 100k residents MN Wisconsin: no data reported WI Michigan: 3,267 units · 32.5 per 100k residents MI New York: 4,097 units · 20.9 per 100k residents NY Vermont: no data reported VT New Hampshire: 392 units · 28.0 per 100k residents NH Oregon: 1,056 units · 24.9 per 100k residents OR Nevada: 1,905 units · 59.6 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 104 units · 3.2 per 100k residents IA Illinois: 10,977 units · 87.5 per 100k residents IL Indiana: 2,845 units · 41.5 per 100k residents IN Ohio: 3,679 units · 31.2 per 100k residents OH Pennsylvania: 2,375 units · 18.3 per 100k residents PA New Jersey: 1,241 units · 13.4 per 100k residents NJ Massachusetts: 28,713 units · 410 per 100k residents MA California: 14,506 units · 37.2 per 100k residents CA Utah: 163 units · 4.8 per 100k residents UT Colorado: 679 units · 11.6 per 100k residents CO Nebraska: 13 units · 0.7 per 100k residents NE Missouri: no data reported MO Kentucky: 5,069 units · 112 per 100k residents KY West Virginia: 288 units · 16.3 per 100k residents WV Virginia: 10,071 units · 116 per 100k residents VA Maryland: 6,976 units · 113 per 100k residents MD Connecticut: 123 units · 3.4 per 100k residents CT Rhode Island: 594 units · 54.2 per 100k residents RI Arizona: 4,941 units · 66.5 per 100k residents AZ New Mexico: 921 units · 43.6 per 100k residents NM Kansas: 107 units · 3.6 per 100k residents KS Arkansas: 697 units · 22.7 per 100k residents AR Tennessee: 798 units · 11.2 per 100k residents TN North Carolina: 5,811 units · 53.6 per 100k residents NC South Carolina: 167 units · 3.1 per 100k residents SC Delaware: 903 units · 87.6 per 100k residents DE Oklahoma: 3,955 units · 97.6 per 100k residents OK Louisiana: 575 units · 12.6 per 100k residents LA Mississippi: 32 units · 1.1 per 100k residents MS Alabama: 63 units · 1.2 per 100k residents AL Georgia: 246 units · 2.2 per 100k residents GA D.C.: 340 units · 50.1 per 100k residents DC Hawaii: 150 units · 10.5 per 100k residents HI Texas: 818 units · 2.7 per 100k residents TX Florida: 310 units · 1.4 per 100k residents FL
Units reimbursed · per 100k residents
0.7410
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 Massachusetts 410 /100k
2 Virginia 116 /100k
3 Maryland 113 /100k
4 Kentucky 112 /100k
5 Oklahoma 97.6 /100k
6 Delaware 87.6 /100k
7 Illinois 87.5 /100k
8 Arizona 66.5 /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.
← 00480-3475-16 · Teva 00480-3479-06 · Teva →
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.