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COCAINE HYDROCHLORIDE 40 mg/mL Solution — NDC 70839-0362-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

COCAINE HYDROCHLORIDE 40 mg/mL Solution — NDC 70839-362-04 (Billing 70839-0362-04)

by LXO US INC. · 1 BOTTLE, GLASS in 1 CARTON / 4 mL in 1 BOTTLE, GLASS

This is a package of COCAINE HYDROCHLORIDE 40 mg/mL Solution from LXO US INC., marketed since Jan 2024 and currently FDA-listed. It is this product's only package size.

NDC 70839-0362-04
🏷️ FDA NDC (as labeled) 70839-362-04 billing pads the product segment with a zero
Rx only Brand On market CII ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 70839-362-04 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70839 labeler · 362 product · 04 package
Package marketed since
Jan 29, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7083936204 5
Medicaid fills, this package
67 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) 70839-362-04
Product NDC 70839-362
11-digit billing NDC 70839036204
NCPDP billing unit ML — per mL (volume)
RxCUI 1995288
UNII XH8T8T6WZH
Application # NDA209963
SPL Set ID 0fb0298f-9756-26e8-e063-6294a90ae8f2
DEA schedule CII
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-01-29
Route NASAL
Dosage form SOLUTION
Substance COCAINE HYDROCHLORIDE

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

GCN Seq No 078068
GCN 44324
HICL code 001519
Ingredient (HICL) Cocaine Hcl
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q7
Therapeutic class — intermediate (HIC2) Nasal Preparations
HIC3 code Q7A
Therapeutic class — specific (HIC3) Nose Preparations, Miscellaneous (Rx)
AHFS code 52:16.00.00
AHFS class Local Anesthetics (Eent)
FDB label name COCAINE 160 MG/4 ML NASAL SOLN
FDB brand name Cocaine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 078068
  • GCN: 44324
  • HICL (First Databank): 001519
  • AHFS class code: 52:16.00.00
  • RxCUI (RxNorm): 1995288
Why two NDCs? The FDA registers this code as 70839-362-04 — 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 → 70839-0362-04. 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 Esters of benzoic acid class.

Drug family (ATC) Esters of benzoic acid, Anesthetics, local, Local anesthetics
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 COCAINE 160 MG/4 ML NASAL SOLN Ingredient Cocaine Hcl
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 $84.15 $336.59 / 4 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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
70839-0362-04 You're viewing this Main listing 1 BOTTLE, GLASS in 1 CARTON / 4 mL in 1 BOTTLE, GLASS 2024-01-29 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Goprelto 40 mg/mL 70839-0359-04 LXO 1 bottle — — FDA listed —
Cocaine Hydrochloride 40 mg/mLthis 70839-0362-04 LXO 1 bottle — — FDA listed —
Numbrino 40 mg/mL 81665-0300-02 OMNIVIUM 1 bottle — — FDA listed —
cocaine hydrochloride nasal 40 mg/mL 81665-0301-02 OMNIVIUM 1 bottle — — FDA listed —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. 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

🏛️
2017
First FDA approval
Dec 2017
📍
2026
Currently FDA-listed
9 years listed
🛡️
2037
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Feb 2037. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 14, 2017 RLD RS ⏳ ~10.3 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 10016407 — method of use (U-2329)
US 9867815 — method of use (U-2225)
US 9867815 — method of use (U-2226)
US 9867815 — method of use (U-2227)
US 10413505 — method of use (U-2479)
US 10420760 — method of use (U-2478)
US 10149843 — method of use (U-2479)
US 10149843 — method of use (U-2478)
US 10933060 — method of use (U-3014)
US 10973811 — method of use (U-2226)
US 10987347 — method of use (U-2225)
US 10894012 — method of use (U-3014)
US 10857095 — method of use (U-3014)
US 10231961 — drug product
US 11040032 — drug product
2017 2019 2021 2023 2025 2027 2029 2031 2033 2035 2037
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (15)
PatentTypeUse codeExpires
US 10016407 ↗ Method of use U-2329 Feb 7, 2037
US 9867815 ↗ Method of use U-2225 Feb 7, 2037
US 9867815 ↗ Method of use U-2226 Feb 7, 2037
US 9867815 ↗ Method of use U-2227 Feb 7, 2037
US 10413505 ↗ Method of use U-2479 Feb 7, 2037
US 10420760 ↗ Method of use U-2478 Feb 7, 2037
US 10149843 ↗ Method of use U-2479 Feb 7, 2037
US 10149843 ↗ Method of use U-2478 Feb 7, 2037
US 10933060 ↗ Method of use U-3014 Feb 7, 2037
US 10973811 ↗ Method of use U-2226 Feb 7, 2037
US 10987347 ↗ Method of use U-2225 Feb 7, 2037
US 10894012 ↗ Method of use U-3014 Feb 7, 2037
US 10857095 ↗ Method of use U-3014 Feb 7, 2037
US 10231961 ↗ Drug product — Feb 7, 2037
US 11040032 ↗ Drug product — Feb 7, 2037
Common questions
Is there a generic version of COCAINE 160 MG/4 ML NASAL SOLN?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for COCAINE 160 MG/4 ML NASAL SOLN. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Feb 2037 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

What it looks like

Color green
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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII 3P3ONR6O1S
    A synthetic green dye approved by the FDA for use in medicines and foods. It serves as a colorant to make the pill or liquid visually distinctive and help with product identification.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • 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.

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

LabelerLXO US INC.
Application holderLXO IRELAND DESIGNATED ACTIVITY CO
FDA applicationNDA209963 (NDA AUTHORIZED GENERIC)
Labeler code70839
First marketedJan 2024
DEA scheduleCII
Product typeHuman Prescription Drug
Portfolio4 products on file

More NDCs from LXO US INC. labeler code 70839

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 50 words ▾

WARNING: ABUSE AND DEPENDENCE CNS stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence [see Warning and Precautions (5.1) .] WARNING: ABUSE AND DEPENDENCE See full prescribing information for complete boxed warning. CNS stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence. ( 5.1)

🎯 Indications and Usage 75 words ▾

1 INDICATIONS AND USAGE COCAINE HYDROCHLORIDE nasal solution is an ester local anesthetic indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults. COCAINE HYDROCHLORIDE nasal solution is an ester local anesthetic indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults. ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION • For intranasal use only. ( 2.1 ) • Recommended dose: two pledgets, each containing 40 mg of cocaine hydrochloride, applied to each nasal cavity. ( 2.2 ) • Do not apply to damaged nasal mucosa.

( 2.1 ) • Preparation and Application: – In a small container, soak four pledgets in the full contents (4 mL) of one bottle of COCAINE HYDROCHLORIDE nasal solution until the solution is fully absorbed. Each pledget absorbs 1 mL of solution, equivalent to 40 mg cocaine hydrochloride. ( 2.2 , 2.3 ) – Following soaking, place two pledgets in each nasal cavity against the septum.

( 2.3 ) – Leave pledgets in place for up to 20 minutes. ( 2.3 )

2.1Important Dosage and Administration Instructions • COCAINE HYDROCHLORIDE nasal solution is for intranasal use only. • Do not apply COCAINE HYDROCHLORIDE nasal solution to damaged nasal mucosa.

2.2Dosing Recommendation for Adults The recommended dose of COCAINE HYDROCHLORIDE nasal solution is two soaked cottonoid pledgets placed in each nasal cavity, equivalent to 40 mg cocaine hydrochloride per pledget, for a total dose of 160 mg for four pledgets. The total dose for any one procedure or surgery should not exceed 160 mg, or 3 mg/kg, cocaine hydrochloride. The recommended size of cottonoid pledgets for use with COCAINE HYDROCHLORIDE nasal solution measure 1.3 cm x 4 cm (sold separately).

2.3Preparation and Administration of COCAINE HYDROCHLORIDE nasal solution Pledgets Pour the full contents of one 4 mL (160 mg) bottle of COCAINE HYDROCHLORIDE nasal solution into a small container. Soak four cottonoid pledgets until the solution is fully absorbed. Following soaking, place two pledgets in each nasal cavity against the septum.

Leave pledgets in place for up to twenty minutes. Remove pledgets and continue with the procedure. Discard pledgets and dispose of any unused portion of solution in accordance with institutional procedures for CII products.

💊 Dosage Forms and Strengths 64 words ▾

3 DOSAGE FORMS AND STRENGTHS COCAINE HYDROCHLORIDE nasal solution is provided as a 4% solution, 160 mg/4 mL (40 mg/mL), equivalent to 142.4 mg/4 mL (35.6 mg/mL) cocaine, and is a clear, greencolored solution in a single-unit bottle. Nasal solution: 160 mg/4 mL (40 mg/mL or 4%) cocaine hydrochloride, equivalent to 142.4 mg/4 mL (35.6 mg/mL) cocaine, in a single-unit bottle. ( 3 )

⛔ Contraindications 49 words ▾

4 CONTRAINDICATIONS COCAINE HYDROCHLORIDE nasal solution is contraindicated in patients with a known history of hypersensitivity to cocaine hydrochloride, other ester-based anesthetics, or any other component of the product. Known hypersensitivity to cocaine hydrochloride, other ester-based anesthetics, or any other component of COCAINE HYDROCHLORIDE nasal solution. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Seizures: COCAINE HYDROCHLORIDE nasal solution may lower the convulsive threshold. Monitor patients for development of seizures. (5.2) • Blood Pressure and Heart Rate Increases: Monitor vital signs, including heart rate and rhythm, in patients after receiving COCAINE HYDROCHLORIDE nasal solution.

Avoid use of COCAINE HYDROCHLORIDE nasal solution in patients with a recent or active history of uncontrolled hypertension, unstable angina, myocardial infarction, coronary artery disease, or congestive heart failure. (5.3)

5.1Potential for Abuse and Dependence Central nervous system (CNS) stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence [see Drug Abuse and Dependence ( 9.2 , 9.3 )].

5.3Blood Pressure and Heart Rate Increases As reported in the literature, cocaine hydrochloride causes an increase in observed blood pressure and heart rate. In the Phase 3 clinical study with COCAINE HYDROCHLORIDE nasal solution, increases in blood pressure and heart rate were observed for 60 minutes or longer following pledget removal. Monitor for vital sign changes, including heart rate and rhythm, after administration of COCAINE HYDROCHLORIDE nasal solution.

Avoid use of COCAINE HYDROCHLORIDE nasal solution in patients with a recent or active history of uncontrolled hypertension, unstable angina, myocardial infarction, coronary artery disease, or congestive heart failure. Avoid use of additional vasoconstrictor agents such as epinephrine or phenylephrine with COCAINE HYDROCHLORIDE nasal solution. If concomitant use is unavoidable, prolonged vital sign and ECG monitoring may be required [see Drug Interactions ( 7 )].

5.4Toxicology Screening The cocaine hydrochloride in COCAINE HYDROCHLORIDE nasal solution may be detected in plasma for up to one week after administration. Cocaine hydrochloride and its metabolites may be detected in urine toxicology screening for longer than one week after administration.

5.2Seizures It has been reported in the literature that cocaine hydrochloride may lower the convulsive threshold. The risk may be higher in patients with a history of seizures or in patients with prior electroencephalogram (EEG) abnormalities without seizures, but has been reported in patients with no prior history or EEG evidence of seizures. Monitor patients for development of seizures.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (>0.5%) occurring in patients treated with COCAINE HYDROCHLORIDE nasal solution 4% were headache and epistaxis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LXO US., INC. at 1-844-800-8007 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. COCAINE HYDROCHLORIDE nasal solution has been evaluated in four Phase 1 studies and one Phase 3 study, which included 647 adult subjects who received a single topical intranasal 160 mg dose (four pledgets), of COCAINE HYDROCHLORIDE nasal solution.

The randomized, double-blind, controlled Phase 3 study was conducted in adult patients undergoing diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities, of which 278 received COCAINE HYDROCHLORIDE nasal solution (4% solution), 275 received cocaine hydrochloride solution 8%, and 95 received placebo. Safety was evaluated for up to 7 days after dosing. The most commonly reported adverse reactions (>1 patient) to occur in the Phase 3 study with COCAINE HYDROCHLORIDE nasal solution (4% solution) were headache and epistaxis.

Two adverse reactions of headache were severe (Table 1). No premature discontinuations due to an adverse event, serious adverse events, or deaths were reported in the Phase 3 clinical study. Table 1: Common Adverse Reactions with COCAINE HYDROCHLORIDE nasal solution (4%) in >1 Patient System Organ Class / Preferred Term COCAINE HYDROCHLORIDE nasal solution (4% solution) (N=278) Cocaine Hydrochloride Solution 8% (N=275) Placebo (N=95) Nervous System Disorders Headache 7 (3%) 4 (2%) 1 (1%) Respiratory, Thoracic, and Mediastinal Disorders Epistaxis 3 (1%) 2 (1%) 0 Psychiatric Disorders Anxiety 0 2 (1%) 0

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS • Disulfiram : Increases plasma cocaine exposure. Avoid using COCAINE HYDROCHLORIDE nasal solution in patients taking disulfiram. ( 7 ) • Epinephrine, Phenylephrine : There have been reports of myocardial ischemia, myocardial infarction, and ventricular arrhythmias with concomitant use during nasal surgery.

Avoid use of additional vasoconstrictor agents with COCAINE HYDROCHLORIDE nasal solution. If concomitant use is unavoidable, prolonged vital sign and ECG monitoring may be required. ( 5.3 , 7 )

7.1Disulfiram Published literature reported that disulfiram treatment increased plasma cocaine exposure, including both AUC and Cmax, by several fold after acute intranasal cocaine administration. Other literature reported that co-administration of disulfiram increased AUC of plasma cocaine by several fold after intravenous cocaine administration [see Clinical Pharmacology ( 12.3 )]. Avoid using COCAINE HYDROCHLORIDE nasal solution in patients taking disulfiram.

Consider using other local anesthetic agents.

7.2Epinephrine, Phenylephrine There are reports in the published literature of myocardial ischemia, myocardial infarction, and ventricular arrhythmias after concomitant administration of topical intranasal cocaine with epinephrine and phenylephrine during nasal and sinus surgery. Avoid use of additional vasoconstrictor agents such as epinephrine and phenylephrine with COCAINE HYDROCHLORIDE nasal solution during nasal and sinus surgery. If concomitant use is unavoidable, prolonged vital sign and ECG monitoring may be required [see Warnings and Precautions ( 5.3 )].

7.3Inhibitors of plasma cholinesterase (pseudocholinesterase) Cocaine has been described in literature to be primarily metabolized and inactivated by non-enzymatic ester hydrolysis and hepatic carboxylesterase, and also by plasma cholinesterase, hepatic carboxylesterase, and CYP3A4 [see Clinical Pharmacology ( 12.3 )]. The pharmacokinetics of COCAINE HYDROCHLORIDE nasal solution in patients with reduced plasma cholinesterase activity has not been studied. Plasma cholinesterase activity may be decreased by chronic administration of certain monoamine oxidase inhibitors, oral contraceptives, or glucocorticoids.

It may also be diminished by administration of irreversible plasma cholinesterase inhibitors such as echothiophate, organophosphate insecticides, and certain antineoplastic agents. Patients with reduced plasma cholinesterase (pseudocholinesterase) activity may have reduced clearance and increased exposure of plasma cocaine after administration of COCAINE HYDROCHLORIDE nasal solution Since cocaine is metabolized by multiple enzymes, the effect of reduced plasma cholinesterase activity on cocaine exposure may be limited.

No dosage adjustment of COCAINE HYDROCHLORIDE nasal solution is needed in patients with reduced plasma cholinesterase. Monitor patients with reduced plasma cholinesterase activity for adverse reactions such as headache, epistaxis, and clinically- relevant increases in heart rate or blood pressure.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pregnancy: May cause fetal harm. (8.1) • Lactation: Avoid breastfeeding for 48 hours after treatment. (8.2) • Hepatic Impairment: Monitor for adverse reactions such as headache, epistaxis, and clinically-relevant increases in heart rate or blood pressure. Do not administer a second dose within 24 hours of the first dose. (8.7)

8.1Pregnancy Risk Summary In animal studies conducted in accordance with good laboratory practices, malformations including vertebral and rib abnormalities were reported when pregnant rabbits were treated with 16 mg/kg cocaine hydrochloride during organogenesis (8 times the adult human exposure following administration of pledgets containing 160 mg of cocaine) and increased pup mortality was noted when pregnant rats were exposed to cocaine hydrochloride during pregnancy at 47 times the adult human AUC exposures. Published rodent studies testing high exposures to cocaine during organogenesis report various malformations at 17 to 34 times the adult human AUC exposures following administration of pledgets containing 160 mg of cocaine.

Data Human Data There are no available data on the use of intranasal cocaine hydrochloride solution in pregnant women to inform a drug-associated risk adverse developmental outcomes. There are published data describing adverse developmental outcomes in women with chronic cocaine abuse during pregnancy. The published case-control and observational studies examining the effect of in utero cocaine exposure on fetal growth parameters, after controlling for confounding variables, found exposure was associated with reduced fetal growth compared with non-drug-abuse populations.

Published data from a large number of studies of women with chronic cocaine abuse during pregnancy are inconsistent in their findings with regard to other developmental outcomes. Prospective studies controlling for polydrug use (marijuana, alcohol, tobacco) and lifestyle factors, have not demonstrated any association between cocaine abuse and specific major or minor fetal anomalies or other forms of fetal harm (premature birth, stillbirth, miscarriage, low birth weight, reduced head circumference, or placental abruption).

The applicability of the findings from these studies of chronic abuse in pregnancy to a single topical exposure is limited. Animal Data No clear evidence of fetal malformations was noted in a study where pregnant rats were treated subcutaneously with up to 30 mg/kg cocaine hydrochloride (48 times the human adult exposure based on AUC following administration of pledgets containing 160 mg of cocaine) from Gestation Day 7 through 17 in the absence of overt maternal rat toxicity. However, a single high-dose fetus was reported with both meningoencephalocele and anophthalmia (unilateral).

Malformations, including vertebral and rib anomalies, were observed when pregnant rabbits were treated subcutaneously with 16 mg/kg cocaine hydrochloride (8 times the human adult exposure based on AUC exposures following administration of pledgets containing 160 mg of cocaine) from Gestation Day 7 through 20. This dose level was associated with evidence of maternal toxicity (convulsions, decreased body weight gain). No adverse effects were noted in animals treated with 8 mg/kg (1.5 times the adult human AUC following administration of pledgets containing 160 mg of cocaine).

An increased incidence of pup mortality between Postnatal Day (PND) 0 to PND 4 and decreased pup body weights from PND 1 to PND 21 were noted when pregnant rats were treated from GD 6 through Lactation Day 20 with 20 mg/kg cocaine hydrochloride (47 times the adult human AUC following administration of pledgets containing 160 mg of cocaine) in the absence of overt maternal toxicity. There was no adverse effect on pre- or postnatal development at 6 mg/kg (7 times the human adult AUC exposure following administration of pledgets containing 160 mg cocaine).

Published studies in pregnant mice suggest that high expos… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 186 words ▾

10 OVERDOSAGE No cases of overdose with COCAINE HYDROCHLORIDE nasal solution were reported in clinical trials. Blood pressure and heart rate increases were greater with cocaine hydrochloride solution 8% than with COCAINE HYDROCHLORIDE nasal solution. In the case of an overdose, consult with a certified poison control center (1-800-222-1222) for upto- date guidance and advice for treatment of overdosage.

Individual patient response to cocaine varies widely. Toxic symptoms may occur idiosyncratically at low doses. Manifestations of cocaine overdose associated with illicit use of cocaine reported in literature and based on reports in FDA’s Adverse Events Reporting System (AERS) database include death, cardio- respiratory arrest, cardiac arrest, respiratory arrest, tachycardia, myocardial infarction, agitation, aggression, restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia, and rhabdomyolysis.

Fatigue and depression usually follow the central nervous system stimulation. Other reactions include arrhythmias, hypertension or hypotension, circulatory collapse, nausea, vomiting, diarrhea, and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.

Because cocaine is significantly distributed to tissues and rapidly metabolized, dialysis and hemoperfusion are not effective. Acidification of the urine does not significantly enhance cocaine elimination.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Cocaine hydrochloride is a local anesthetic of the ester type. Cocaine hydrochloride prevents conduction in nerve fibers by reversibly blocking sodium channels and preventing the transient rise in sodium conductance necessary for generation of an action potential.

12.2Pharmacodynamics Cardiac Electrophysiology The effect of COCAINE HYDROCHLORIDE nasal solution on the QTc interval was evaluated in a randomized, positive- and placebo-controlled four-period crossover thorough QTc study in 24 healthy subjects. No clinically relevant QTc prolongation was observed at the highest clinically relevant concentrations with a single therapeutic dose.

12.3Pharmacokinetics Absorption The pharmacokinetics of COCAINE HYDROCHLORIDE nasal solution have been assessed in 74 healthy adult subjects across 4 studies. Following intranasal application of two 40 mg pledgets applied to each nasal cavity (160 mg cocaine hydrochloride total dose) for 20 minutes, the geometric mean (SD) cocaine Cmax was 43.2 (1.73) ng/mL. The median (range) time to peak plasma concentration (tmax) was 0.42 (0.25 – 1.75) hours after pledget application.

Distribution Cocaine has been described in literature as approximately 84 – 92% bound to human plasma proteins, binding primarily to alpha-1-acid glycoprotein (AAG) and albumin. In studies with COCAINE HYDROCHLORIDE nasal solution, the apparent volume of distribution (Vd/F) of cocaine after intranasal administration is 3,877 ± 1,266 L. Elimination Metabolism Cocaine has been described in literature to be primarily metabolized and inactivated by non-enzymatic ester hydrolysis and hepatic carboxylesterase 1 to form benzoylecgonine (BE), and by plasma cholinesterase and hepatic carboxylesterase 2 to form ecgonine methyl ester (EME).

In human liver microsomes, cocaine undergoes CYP3A4 mediated N-demethylation to produce a minor metabolite, norcocaine, which is pharmacologically active. Excretion Cocaine has been described in literature to be primarily eliminated by biotransformation to inactive metabolites, BE and EME. Less than 10% of the administered dose is excreted unchanged in the urine.

BE and EME are both predominantly excreted by the kidneys. In studies with COCAINE HYDROCHLORIDE nasal solution, 0-32 hour urinary recoveries of cocaine, BE, and EME as a percentage of dose were approximately 0.1%, 2.0%, and 1.0%, respectively. The mean elimination half-life of cocaine was 1.0 to 1.7 hours; with longer plasma sampling (32 hours) and a highly sensitive assay, mean half-life values of 5.0 to 8.0 hours were observed at very low plasma concentrations.

The apparent clearance of cocaine after intranasal administration of COCAINE HYDROCHLORIDE nasal solution (CL/F) is 3096 ± 1276 L/h. Specific Populations In studies with COCAINE HYDROCHLORIDE nasal solution, cocaine exposure (i.e., Cmax, AUClast, and AUCinf) was slightly higher in females than males whereas tmax and half-life were similar in males and females. COCAINE HYDROCHLORIDE nasal solution pharmacokinetics are not affected by age or weight.

Renal Impairment In a pharmacokinetic study of COCAINE HYDROCHLORIDE nasal solution in subjects with normal and severe renal impairment (eGFR 15-29 mL/min/1.73 m2), mean AUC and Cmax were slightly higher in subjects with severe renal impairment compared to those with normal renal function and clearance was slightly lower [see Use in Specific Populations (8.6) ]. Hepatic Impairment In a pharmacokinetic study of COCAINE HYDROCHLORIDE nasal solution in subjects with normal, Child-Pugh Class B, and Child-Pugh Grade C hepatic impairment, there was a minimal effect of hepatic impairment on cocaine Cmax.

In moderately impaired subjects (n=9) there was a higher than two-fold increase in AUC (79.2 ng.h/mL in normal subjects to 225 ng.h/mL in Child-Pugh Grade B subjects) and the clearance was reduced by more than half (1735 L/h in normal 629 L/h in Child-Pugh Grade B subjects). In severely impair… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 70 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING COCAINE HYDROCHLORIDE nasal solution is a clear, green colored liquid available as one dosage strength: 160 mg/4 mL (40 mg/mL or 4%) cocaine hydrochloride, equivalent to 142.4 mg/4 mL (35.6 mg/mL) cocaine NDC # 70839-362-04: Single-unit 4 mL bottle Store upright at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP, Controlled Room Temperature (CRT)]. Avoid freezing.

📋 Description 82 words ▾

11 DESCRIPTION COCAINE HYDROCHLORIDE nasal solution for intranasal use contains a 4% solution, 160 mg/4 mL (40 mg/mL), equivalent to 142.4 mg/4 mL (35.6 mg/mL) cocaine, an ester local anesthetic. The chemical name for cocaine hydrochloride is (1R,2R,3S,5S) methyl 3-(benzoyloxy)-8-methyl- 8-azabicyclo[3.2.1]octane-2-carboxylate hydrochloride. The molecular formula is C1 7 H2 1 NO4 •HCl and the molecular weight is 339.81.

The structural formula is: Inactive ingredients are anhydrous citric acid, D&C Yellow No. 10, FD&C Green No. 3, sodium benzoate, and purified water. structure

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES A double-blind, multicenter, single-dose, placebo- and dose-controlled, parallel-group study was conducted in 648 subjects undergoing diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities. Subjects were randomized to receive COCAINE HYDROCHLORIDE nasal solution (n=278), cocaine hydrochloride solution 8% (n=275), to explore the dosing range, or placebo (n=95). Nasal endoscopy, nasal laryngoscopy, nasopharyngeal laryngoscopy, and nasal debridement comprised 88% of all procedures performed in the COCAINE HYDROCHLORIDE nasal solution (n=278), cocaine hydrochloride solution 8% (n=275), to explore the dosing range, or placebo (n=95).

Nasal endoscopy, nasal laryngoscopy, nasopharyngeal laryngoscopy, and nasal debridement comprised 88% of all procedures performed in the COCAINE HYDROCHLORIDE nasal solution group and 85% of all procedures performed in the placebo group. All subjects completed the diagnostic or surgical procedure. In the COCAINE HYDROCHLORIDE nasal solution group, two 40 mg pledgets were applied to the septum in each nasal cavity (160 mg cocaine hydrochloride total dose) and left in place for up to 20 minutes.

Similarly, pledgets were applied in the placebo group. Topical anesthesia was assessed using the visual numeric rating scale (VNRS) during a von Frey Filament test prior to the diagnostic procedure or surgery. After subject-reported pain scores were collected, the blind to placebo was broken and placebo subjects were provided the option of receiving anesthesia.

The primary efficacy endpoint was analgesic success, defined in the COCAINE HYDROCHLORIDE nasal solution group as a subject-reported pain score of 0 (no pain) on the VNRS during the von Frey Filament test, and no additional anesthetic or analgesic medication administration during the diagnostic procedure or surgery. Analgesic success was defined in the placebo group as a subjectreported pain score of 0 on the VNRS during the von Frey Filament test. Subjects did not receive supplemental intravenous sedation or general anesthesia during the study.

Table 2 provides the efficacy results for the primary endpoint of analgesic success showing a significant difference in the analgesic success rate between placebo and COCAINE HYDROCHLORIDE nasal solution. Table 2: Analgesic Success Event Cocaine hydrochloride nasal solution (N=278) n (%) Placebo (N=95) n (%) Success 215 (77%) 14 (15%) Failure 63 (23%) 81 (85%) Of the 63 (23%) failures in the COCAINE HYDROCHLORIDE nasal solution group, 4 subjects requested additional anesthetic medication. Of these 4 subjects, 1 subject reported 0 on the VNRS during the von Frey Filament test.

Of the 81 (85%) failures in the placebo group, 50 subjects required additional anesthetic medication.

🔒 Drug Abuse and Dependence ~2 min read ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance COCAINE HYDROCHLORIDE nasal solution contains cocaine, a Schedule II controlled substance.

9.2Abuse COCAINE HYDROCHLORIDE nasal solution contains cocaine, a substance with a high potential for abuse. COCAINE HYDROCHLORIDE nasal solution can be misused and abused, which can lead to addiction. COCAINE HYDROCHLORIDE nasal solution may also be diverted for abuse purposes [see Warning and Precautions (5.1) ].

Drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. Drug addiction is a cluster of behavorial, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal.

Drug abuse of a substance may occur without progression to drug addiction. “Drug-seeking” behavior is very common in persons with substance use disorders. Drug abuse and addiction are conditions that are separate and distinct from physical dependence and tolerance [see Dependence (9.3) ]. Health care providers should be aware that abuse and addiction may occur in the absence of symptoms indicative of physical dependence and tolerance.

Individuals who abuse stimulants may use COCAINE HYDROCHLORIDE nasal solution for abuse purposes. Adverse events associated with abuse of cocaine include euphoria, excitation, irritability, restlessness, anxiety, paranoia, confusion, headache, psychosis, hypertension, stroke, seizures, dilated pupils, nausea, vomiting, and abdominal pain. Intranasal abuse can produce damage to the nostrils (e.g., ulceration and deviated septum).

Abuse of cocaine can result in overdose, convulsions, unconsciousness, coma, and death [see Overdosage (10) ]. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. COCAINE HYDROCHLORIDE nasal solution, like all prescription drugs with abuse potential, can be diverted for non-medical use into illicit channels of distribution.

In order to minimize these risks, effective accounting procedures should be implemented, in addition to routine procedures for handling controlled substances

9.3Dependence Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. COCAINE HYDROCHLORIDE nasal solution is approved for topical single use during diagnostic procedures and surgeries, so physical dependence and withdrawal symptoms are unlikely to develop. Although COCAINE HYDROCHLORIDE nasal solution is not indicated for chronic therapy, repeated misuse or abuse of this product may lead to physical dependence.

🧪 Nonclinical Toxicology 175 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term animal studies to evaluate the carcinogenic potential of cocaine have not been conducted. Mutagenesis In published studies, cocaine was genotoxic in the in vitro chromosomal aberration assay, the in vitro sister chromatid exchange assay, the in vitro micronucleus assay, and the in vitro hypoxanthine- guanine phosphoribosyltransferase (hgprt) assay. Cocaine was equivocal in a published in vivo micronucleus assay and the in vivo comet assay (liver).

Cocaine was not mutagenic in the in vitro bacterial reverse mutation assay (Ames assay). Impairment of Fertility No adverse effects on fertility or early embryonic development were reported in a study where male rats were administered up to 20 mg/kg cocaine hydrochloride via subcutaneous injection for 28 days prior to mating and female rats were treated with the same dose for 14 days prior to mating through Gestation Day 7. The 20 mg/kg/dose resulted in AUC exposures that were 31 times (males) and 47 times (females) the adult human AUC following administration of pledgets containing 160 mg of cocaine.

📄 Package Label / Principal Display Panel 47 words ▾

NDC 70839-362-04 COCAINE HYDROCHLORIDE nasal solution CII 160 mg/4 mL For Topical Use Only. Not for Injection or Ophthalmic Use Single-unit Each 1 mL contains: Cocaine Hydrochloride, USP 40 mg (equivalent to 142.4 mg/4 mL [35.6 mg/mL] cocaine) Rx Only 4 mL LXO US Inc. label 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
67
Units reimbursed last 4 qtrs
111
Gross reimbursed last 4 qtrs
$9.3K
Avg / prescription
$139.41
Avg / unit
$84.1481
Latest quarter Q1 2026
0Rx
Fee-for-service vs managed care ⓘ
16% FFS 84% MCO
Fee-for-service · 11 Rx Managed care · 56 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: 44 units · 2.2 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 67 units · 1.5 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported 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: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
1.52.2
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 Idaho 2.2 /100k
2 Kentucky 1.5 /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.

About this NDC listing & data coverage

Finished prescription 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 ✓ Available
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) ✓ Available
“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 LXO US INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
LXO US INC. 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 70839-0359-04 · LXO 70842-0101-01 · Melinta →
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.