NDC 82584-0792-01 — AKTEN LIDOCAINE HYDROCHLORIDE ANHYDROUS 35

🆔 Identity & classification

FDA NDC (as labeled) 82584-792-01

Product NDC 82584-792

11-digit billing NDC 82584079201

NCPDP billing unit ML — per mL (volume)

RxCUI 1009462, 1011703

UNII EC2CNF7XFP

UPC 0382584792015

Application # NDA022221

SPL Set ID 70ff9fb7-d323-4fe6-b1b1-6033e05f0749

Established class (EPC) Amide Local Anesthetic; Antiarrhythmic

Physiologic effect Local Anesthesia

Chemical class Amides

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2022-12-01

Route OPHTHALMIC

Dosage form GEL

Substance LIDOCAINE HYDROCHLORIDE ANHYDROUS

GPI-14 86750016104020

GCN Seq No 064490

GCN 14424

HICL code 033592

Ingredient (HICL) Lidocaine Hcl/Pf

HIC1 code Q

Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other

HIC2 code Q6

Therapeutic class — intermediate (HIC2) Ophthalmic Preparations

HIC3 code Q6H

Therapeutic class — specific (HIC3) Eye Local Anesthetics

AHFS code 52:16.00.00

AHFS class Local Anesthetics (Eent)

FDB label name AKTEN 3.5% GEL DROPS

FDB brand name Akten

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 82584-792-01 — 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 → 82584-0792-01. 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 Antiarrhythmic class.

Pharmacologic class Antiarrhythmic, Amide Local Anesthetic

Drug family (ATC) Antiarrhythmics, class Ib, Local anesthetics, Anesthetics for topical use

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

LabelerThea Pharma Inc.

Application holderTHEA PHARMA INC

FDA applicationNDA022221 (NDA)

Labeler code82584

First marketedDec 2022

Product typeHuman Prescription Drug

Portfolio11 products on file

🔎 All NDCs from Thea Pharma Inc.

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 AKTEN 3.5% GEL DROPS Ingredient Lidocaine Hcl/Pf

📗 Our plain-language guide HelloPharmacist

It's best to avoid using two lidocaine products at the same time unless your doctor says it's okay. When you use multiple products containing a local anesthetic, the total amount a...
Can I use a lidocaine patch and a lidocaine cream at the same time?
No — please don't do this. Heat significantly increases how much lidocaine is absorbed through your skin, which can push drug levels in your blood higher than they should be. Stick...
Can I put a heating pad on the area where I applied a lidocaine patch?

📖 Read our full Lidocaine guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

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 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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.

💲 Pricing

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

Price system	Per g	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Try another pack size: 25 tubes

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Akten 35 mg/mLthis 82584-0792-01	Thea	1 tube	—	—	FDA listed	—

About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.

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

🏛️

2008

First FDA approval

Oct 2008

📍

2026

Currently FDA-listed

18 years listed

🔓

·

Listed protection lapsed

listed protections lapsed 2026

🔒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: The latest listed FDA patent/protection lapsed Jul 2026 — those protections no longer apply, though a generic still needs FDA approval and a manufacturer to market it.

📅 FDA approved Oct 7, 2008 RLD RS

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 8759401 — method of use (U-1523)

2008 2010 2012 2014 2016 2018 2020 2022 2024 2026

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 (1)

Patent	Type	Use code	Expires
US 8759401 ↗	Method of use	U-1523	Jul 24, 2026

Common questions

Is there a generic version of AKTEN 3.5% GEL DROPS?

No FDA-approved generic equivalent is currently listed in the FDA Orange Book for AKTEN 3.5% GEL DROPS. The latest listed protection lapsed in Jul 2026, so a generic is no longer blocked by listed patents/exclusivity — though one still needs FDA approval and a manufacturer willing to market it.

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.

🗺️ 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 82584-0792-01, 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

90

Units reimbursed last 4 qtrs

91

Latest quarter Q4 2025

24Rx

Fee-for-service vs managed care ⓘ

100% MCO

Fee-for-service · 0 Rx Managed care · 90 Rx

State Medicaid map

Units reimbursed · per 100k residents

1.31.3

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 Massachusetts 1.3 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

1 tube this page82584-0792-01 90 Rx

25 tubes82584-0792-25 No Medicaid data

Drug total (last 4 qtrs): 90 Rx · 91 units

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Akten — the program that covers self-administered drugs. 1 manufacturer.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Akten. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Total Part D spend

$3K

Claims incl. refills

24

Beneficiaries

18

Spend / beneficiary

$166.20

Spend / claim

$124.65

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for AKTEN (this brand).

Top reported reactions

Local Anaesthetic Systemic Toxicity8

Visual Acuity Reduced8

Overdose7

Vision Blurred7

Hypertension6

Cystoid Macular Oedema4

Eye Pain4

Age at onset

Adult3

Elderly3

Reporter sex

Male · 44%

Female · 56%

Serious outcomes

Hospitalization38

Life-threatening11

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
82584-0792-01 You're viewing this	1 TUBE in 1 CARTON (82584-792-01) / 1 mL in 1 TUBE	2022-12-01	Active
82584-0792-25	25 TUBE in 1 CARTON (82584-792-25) / 1 mL in 1 TUBE	2022-12-01	Active

Pack size FAQ

What quantity is in NDC 82584-0792-01?

NDC 82584-0792-01 contains 1 tube — 1 tube in 1 carton / 1 ml in 1 tube.

What is the difference between NDC 82584-0792-01 and NDC 82584-0792-25?

Both are AKTEN LIDOCAINE HYDROCHLORIDE ANHYDROUS 35 mg/mL Gel — the drug itself is identical. NDC 82584-0792-01 is the 1 tube package, while NDC 82584-0792-25 is the 25 tubes package.

What NDC number is used to bill for this package of AKTEN LIDOCAINE HYDROCHLORIDE ANHYDROUS 35 mg/mL Gel?

Bill NDC 82584-0792-01 — the 11-digit billing format is 82584079201. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 82584-792-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 82584-0792-01, written without dashes as 82584079201. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 82584-0792-01, the first segment (82584) is the labeler code FDA assigned to Thea Pharma Inc.; the middle segment (0792) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.

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 Thea Pharma Inc.. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 1 other package presentation of this same product, including 25 tubes (82584-0792-25). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Thea Pharma 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description

🎯 Indications and Usage 36 words ▾

1- INDICATIONS AND USAGE AKTEN is indicated for ocular surface anesthesia during ophthalmologic procedures in adults and pediatric patients. AKTEN is an amide local anesthetic indicated for ocular surface anesthesia during ophthalmologic procedures. ( 1 )

⏱️ Dosage and Administration 63 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dose of AKTEN is 2 drops applied to the ocular surface in the area of the planned procedure. AKTEN may be reapplied to maintain anesthetic effect. The recommended dose of AKTEN is 2 drops applied to the ocular surface in the area of the planned procedure. AKTEN may be reapplied to maintain anesthetic effect. ( 2 )

💊 Dosage Forms and Strengths 25 words ▾

3 DOSAGE FORMS AND STRENGTHS Ophthalmic Gel: 3.5% lidocaine hydrochloride in single-patient use tubes. Ophthalmic Gel: 3.5% lidocaine hydrochloride in single-patient-use tubes. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions 180 words ▾

5 WARNINGS AND PRECAUTIONS For Topical Ophthalmic Use: AKTEN is not for injection or intraocular administration. ( 5.1 ) Patients should not touch the eye for at least 10 to 20 minutes after using AKTEN as accidental injuries can occur due to insensitivity of the eye. ( 5.2 ) Corneal Opacification: Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss.

( 5.2 ) For Administration by Healthcare Provider: AKTEN is not intended for patient self-administration. ( 5.3 )

5.1For Topical Ophthalmic Use AKTEN is not for injection or intraocular administration.

5.2Corneal Injury Due to Insensitivity Patients should not touch the eye for at least 10 to 20 minutes after using AKTEN as accidental injuries can occur due to insensitivity of the eye.

5.3Corneal Opacification Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss.

5.4For Administration by Healthcare Provider AKTEN is indicated for administration under the direct supervision of a healthcare provider. AKTEN is not intended for patient self-administration.

🤒 Adverse Reactions 59 words ▾

6 ADVERSE REACTIONS Most common adverse reactions are conjunctival hyperemia, corneal epithelial changes, headache, and burning upon instillation. Most common adverse reactions are conjunctival hyperemia, corneal epithelial changes, headache, and burning upon instillation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Thea Pharma Inc. at 1-833-838-4028 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION.

👥 Use in Specific Populations 212 words ▾

8 USE IN SPECIFIC POPULATIONS .

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with AKTEN in pregnant women to inform a drug-associated risk. In animal reproduction studies, subcutaneous administration of lidocaine to pregnant rats at doses >800-fold the human dose based on body surface area did not result in adverse developmental effects. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

8.2Lactation Risk Summary Lidocaine is secreted in human milk. The clinical significance of this observation is unknown. Caution should be exercised when AKTEN is administered to a nursing woman.

8.4Pediatric Use The safety and effectiveness of AKTEN for ocular surface anesthesia during ophthalmologic procedures have been established in pediatric patients. Use of AKTEN for this indication has been extrapolated from adequate and well-controlled studies in adults and studies in pediatric patients using different formulations of lidocaine.

8.5Geriatric Use No overall clinical differences in safety or effectiveness were observed between the elderly and other adult patients.

🤰 Pregnancy 108 words ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with AKTEN in pregnant women to inform a drug-associated risk. In animal reproduction studies, subcutaneous administration of lidocaine to pregnant rats at doses >800-fold the human dose based on body surface area did not result in adverse developmental effects. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

🧒 Pediatric Use 48 words ▾

8.4Pediatric Use The safety and effectiveness of AKTEN for ocular surface anesthesia during ophthalmologic procedures have been established in pediatric patients. Use of AKTEN for this indication has been extrapolated from adequate and well-controlled studies in adults and studies in pediatric patients using different formulations of lidocaine.

🧓 Geriatric Use 20 words ▾

8.5Geriatric Use No overall clinical differences in safety or effectiveness were observed between the elderly and other adult patients.

🆘 Overdosage 62 words ▾

10 OVERDOSAGE Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss. Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics or to unintended subarachnoid injection of local anesthetic solution. However, topical ocular application of AKTEN is not expected to result in systemic exposure.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Lidocaine hydrochloride is an amide local anesthetic agent that stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. Anesthesia generally occurs between 20 seconds to 1 minute and persists for 5 to 30 minutes.

12.3Pharmacokinetics Lidocaine may be absorbed following topical administration to mucous membranes. Its rate and extent of absorption depend upon various factors such as concentration, the specific site of application, viscosity of the agent, and duration of exposure. The plasma binding of lidocaine is dependent on drug concentration, and the fraction bound decreases with increasing concentration.

At concentrations of 1 to 4 mcg of free base per mL, 60 to 80 percent of lidocaine is protein bound. Binding is also dependent on the plasma concentration of the alpha-1-acid glycoprotein. Lidocaine is metabolized rapidly by the liver, and metabolites and unchanged drug are excreted by the kidneys.

Biotransformation includes oxidative N- dealkylation, ring hydroxylation, cleavage of the amide linkage, and conjugation. N-dealkylation, a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide and glycinexylidide. The pharmacologic/toxicologic actions of these metabolites are similar to, but less potent than, those of lidocaine.

Approximately 90% of lidocaine administered is excreted in the form of various metabolites, and less than 10% is excreted unchanged. The primary metabolite in urine is a conjugate of 4-hydroxy-2, 6-dimethylaniline. Studies of lidocaine metabolism following intravenous bolus injections have shown that the elimination half-life of this agent is typically 1.5 to 2 hours.

Because of the rate at which lidocaine is metabolized, any condition that affects liver function may alter lidocaine kinetics. The half-life may be prolonged twofold or more in patients with liver dysfunction. Renal dysfunction does not affect lidocaine kinetics but may increase the accumulation of metabolites.

🧬 Mechanism of Action 51 words ▾

12.1Mechanism of Action Lidocaine hydrochloride is an amide local anesthetic agent that stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. Anesthesia generally occurs between 20 seconds to 1 minute and persists for 5 to 30 minutes.

📦 How Supplied / Storage and Handling 78 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING AKTEN (lidocaine hydrochloride ophthalmic gel) 3.5% is supplied as a clear gel in single-patient-use tubes as follows: NDC 82584-792-01 1 mL fill in a white polyfoil tube Made in Switzerland NDC 82584-792-25 Package of 25 units of 1 mL fill in a white polyfoil tube Storage Store at 15°C to 25°C (59°F to 77°F). Keep single-patient-use tubes closed and protected from light in the original carton until ready for use. Discard after use.

📦 Storage and Handling 28 words ▾

Storage Store at 15°C to 25°C (59°F to 77°F). Keep single-patient-use tubes closed and protected from light in the original carton until ready for use. Discard after use.

📋 Description 114 words ▾

11 DESCRIPTION AKTEN (lidocaine hydrochloride ophthalmic gel) 3.5% contains lidocaine hydrochloride, an amide local anesthetic, as a sterile ophthalmic gel for topical ophthalmic use. AKTEN does not contain an anti-microbial preservative. Lidocaine hydrochloride is designated chemically as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl) monohydrochloride with a molecular formula of C 14 H 22 N 2 O ∙ HCl and molecular weight of 270.8.

The structural formula of the active ingredient is: Each mL of AKTEN contains 35 mg of lidocaine hydrochloride as the active ingredient. Inactive ingredients: hypromellose, sodium chloride, and water for injection. The pH may be adjusted to 5.5 to 7.5 with hydrochloric acid and/or sodium hydroxide.

AKTEN does not contain an anti-microbial preservative. Chemical Structure

Glossary — plain-language definitions of medical terms used in this label:

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

Active ingredient: The part of a medicine that produces its intended effect on the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

bolus: A single dose given all at once, often as a quick push into a vein.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

lactation: The making and release of milk from a mother's breasts after giving birth.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

topical: Applied onto the skin, eyes, or another body surface to work mainly where it is placed.

ulceration: The forming of an open sore on the skin or on a lining inside the body, such as the stomach.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

🔗 Related NDC lookups

🧪 All Lidocaine Hydrochloride Anhydrous NDCsSame ingredient 🏭 All Thea labeler NDCsLabeler code 82584 📚 All Amide Local Anesthetic NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Eye Local Anesthetics.

Tetracaine Hcl/Pf 00065-0741-14 Proparacaine Hcl 00404-7199-01 Proparacaine/Fluorescein Sod 59390-0205-05 Benoxinate Hcl/Fluorescein Sod 59390-0218-05 Tetracaine Hcl 68682-0920-05 Chloroprocaine Hcl/Pf 82667-0300-00

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

AKTEN LIDOCAINE HYDROCHLORIDE ANHYDROUS 35 mg/mL Gel, 1 tube

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12 CLINICAL PHARMACOLOGY

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