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Lidocaine 50 mg/g Patch, 30 pouches — NDC 59088-0396-54 package photo

Lidocaine 50 mg/g Patch, 30 pouches

by PureTek Corporation · 30 POUCH in 1 CARTON (59088-396-54) / .7 g in 1 POUCH (59088-396-84)
NDC 59088-0396-54
🏷️ FDA NDC (as labeled) 59088-396-54 billing pads the product segment with a zero
This package
Contains30 pouches Cost per ea$2.03 NADAC Per package$60.93 / 30 pouches Pack sizes2 compare ↓
Also priced by: Medicaid pays $2.28/unit — full pricing hub ↓
Also comes in: 15 pouches 59088-0396-82
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced 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

⚠️
Other active recalls for Lidocaine (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Apr 20, 2023 — Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains. (Bryant Ranch Prepack, Inc.) · FDA recall D-0556-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 59088-396-54
Product NDC 59088-396
11-digit billing NDC 59088039654
NCPDP billing unit EA — each (per item)
RxCUI 1745091
UNII 98PI200987
Application # ANDA200675
SPL Set ID 85e72943-6989-42f4-b519-a3ebbf4bc777
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2013-09-15
Route TOPICAL
Dosage form PATCH
Substance LIDOCAINE
GPI-14 90850060005930
GPI class Lidocaine
GCN Seq No 043256
GCN 50272
HICL code 010705
Ingredient (HICL) Lidocaine
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5H
Therapeutic class — specific (HIC3) Topical Local Anesthetics
AHFS code 72:00.00.00
AHFS class Local Anesthetics
FDB label name LIDOCAINE 5% PATCH
FDB brand name Lidocaine
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 59088-396-54 — 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 → 59088-0396-54. 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

LabelerPureTek Corporation
Application holderACTAVIS LABORATORIES UT INC
FDA applicationANDA200675 (ANDA)
Labeler code59088
First marketedSep 2013
Product typeHuman Prescription Drug
Portfolio178 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name LIDOCAINE 5% PATCH Ingredient Lidocaine
📖 What it is MedlinePlus · NLM

Prescription lidocaine transdermal (Dermalid, Lidoderm, Ztildo) is used to relieve the pain of post-herpetic neuralgia (PHN; burning, stabbing pains, or aches that may last for months or years after a shingles infection). Nonprescription (over-the-counter) lidocaine (Absorbine Jr, Aspercreme, Lidocare, Salonpas, others) is also available to relieve minor pain in shoulders, arms, neck and legs in adults and children 12 years of age and older. Lidocaine is in a class of medications called local anesthetics. It works by stopping nerves from sending pain signals.

Read the full MedlinePlus article ↗
📗 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 →
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 K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII DO250MG0W6
    A mineral compound containing aluminum that acts as an antacid and buffering agent. It helps neutralize stomach acid and is used as a pH buffer to stabilize the medicine's formulation.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 24H4NWX5CO
    Kaolin is a naturally occurring clay mineral. It's used in tablets and capsules as a filler and absorbent to add bulk, improve texture, and help bind ingredients together.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII W4888I119H
    Tartaric acid is a natural organic acid found in grapes and tamarinds. In medicines, it works as a buffer to control acidity, an antioxidant to prevent spoilage, and sometimes a flavoring or binding agent.
  • UNII 8W8T17847W
    A nitrogen-containing chemical compound used in pharmaceuticals as a humectant to retain moisture, and sometimes as a keratolytic agent in topical formulations to help soften and remove dead skin cells.

13 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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $2.031 $60.93 / 30 pouches
Medicaid paysCMS SDUD · 12 mo $2.28 $68.26 / 30 pouches
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Sep 2022 Jan 2024 Mar 2026 Aug 2026 $2.118 $1.807
▲ Up 11% over the last 15 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lidocaine 5% 50 mg/g 82347-0505-05 YARAL 30 patches $1.915 AB FDA listed save 6%
Lidocaine 50 mg/g 00591-2679-30 Actavis 30 pouches $2.031 AB Availability likely —
Lidocaine 50 mg/g 00591-3525-30 Actavis 30 pouches $2.031 AB Availability likely —
Lidocaine 50 mg/g 00603-1880-16 Par 30 pouches $2.031 AB Availability likely —
Lidocan IV 50 mg/g 59088-0910-54 PURETEK 30 pouches $2.031 AB Availability likely —
Lidocaine 700 mg 65162-0791-08 Amneal 30 patches $2.031 AB Availability likely —
Tridacaine XL 50 mg/g 73352-0845-30 Trifluent 30 packets $2.031 AB Availability likely —
Lidocaine 50 mg/gthis 59088-0396-54 PureTek 30 pouches $2.031 AB Discontinued —
Lidocaine 700 mg 42291-0477-30 AvKARE 30 patches — AB FDA listed —
Lidocaine 50 mg/g 42291-0495-30 AVKARE 30 pouches — AB FDA listed —
Lidocaine 50 mg/g 50090-1359-02 A-S 30 pouches — AB FDA listed —
Lidocaine 5% 50 mg/g 50090-7857-02 A-S 30 pouches — AB FDA listed —
Lidocaine 700 mg 50090-7894-02 A-S 30 patches — AB FDA listed —
Lidocaine 50 mg/g 51407-0827-30 Golden 30 pouches — AB FDA listed —
Lidocaine 50 mg/g 55154-2665-05 Cardinal 5 pouches — AB FDA listed —
Lidocaine 50 mg/g 55154-7228-05 Cardinal 5 patches — AB FDA listed —
Lidocaine 50 mg/g 55700-0142-30 Quality 30 pouches — AB FDA listed —
LidoPure Patch 59088-0712-00 PureTek 1 kit — — FDA listed —
Lidoxryl 59088-0722-00 PureTek 1 kit — — FDA listed —
Lidocan VII 50 mg/g 59088-0900-54 PURETEK 30 pouches — AB FDA listed —
Lidocan 700 mg 59088-0905-54 PURETEK 30 patches — AB FDA listed —
Lidocan III 50 mg/g 59088-0907-54 PURETEK 30 patches — AB FDA listed —
Lidocan V 50 mg/g 59088-0909-54 PURETEK 30 pouches — AB FDA listed —
Lidocan VI 50 mg/g 59088-0911-54 PURETEK 30 pouches — AB FDA listed —
Lidocaine 5% 50 mg/g 60760-0657-05 St. 5 patches — AB FDA listed —
Lidocaine 50 mg/g 60760-0880-05 St. 5 pouches — AB FDA listed —
Lidocaine 50 mg/g 61919-0588-30 DIRECT 1 g — AB FDA listed —
Lidoderm 700 mg 61959-0001-30 TPU 30 patches — AB FDA listed —
Lidocaine 50 mg/g 63629-5094-01 Bryant 30 pouches — AB FDA listed —
Lidocaine 50 mg/g 63629-7059-01 Bryant 30 pouches — AB FDA listed —
Lidocaine 50 mg/g 63629-8755-01 Bryant 30 pouches — AB FDA listed —
Lidocaine 5% 700 mg 68071-3620-03 NuCare 30 patches — AB FDA listed —
Lidocaine 50 mg/g 68788-7159-03 Preferred 30 pouches — AB FDA listed —
Lidocaine 700 mg 68788-8344-03 Preferred 30 patches — AB FDA listed —
Lidocaine 50 mg 70518-0566-00 REMEDYREPACK 30 patches — AB FDA listed —
Lidocaine 5% 50 mg/g 70518-4487-00 REMEDYREPACK 30 pouches — AB FDA listed —
Lidocaine 50 mg/g 70518-4502-00 REMEDYREPACK 30 pouches — AB FDA listed —
Lidocaine 50 mg/g 71335-1934-01 Bryant 30 pouches — AB FDA listed —
Lidocaine 700 mg 71335-1971-01 Bryant 30 patches — AB FDA listed —
Lidocaine 700 mg 72162-2085-03 Bryant 30 patches — AB FDA listed —
Lidocaine Patch 700 mg 72189-0387-30 Direct_Rx 30 patches — AB FDA listed —
Tridacaine III 50 mg/g 73352-0835-15 Trifluent 15 packets — AB FDA listed —
Lidocaine 50 mg/g 76420-0037-30 Asclemed 30 pouches — AB FDA listed —
Lidocaine 50 mg/g 76420-0887-30 Asclemed 30 pouches — AB FDA listed —
Lidocaine 5% 50 mg/g 76420-0899-30 Asclemed 30 pouches — AB FDA listed —
Lidocaine 700 mg 80425-0325-01 Advanced 30 patches — AB FDA listed —
Lidocaine 50 mg/g 80425-0404-01 Advanced 30 pouches — AB FDA listed —
Lidocaine 5% Patch 700 mg 82461-0611-15 Medcore 15 patches — AB FDA listed —
Lidocaine 50 mg/g 85509-2880-03 PHOENIX 30 pouches — AB FDA listed —
Lidocaine 50 mg/g 85766-0169-30 Sportpharm 30 pouches — AB FDA listed —
Lidocaine 700 mg 85766-0170-30 Sportpharm 30 patches — AB FDA listed —
Lidox 5 Patch 50 mg/g 87234-0505-03 Injecta 30 pouches — AB FDA listed —
Lidocaine 50 mg/g 67877-0767-30 Ascend 30 pouches — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2013
On the market since
Sep 2013
📍
2026
Currently FDA-listed
13 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 59088-0396-54, 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
78
Units reimbursed last 4 qtrs
2.5K
Gross reimbursed last 4 qtrs
$5.6K
Avg / prescription
$71.84
Avg / unit
$2.2752
Latest quarter Q4 2025
20Rx
Medicaid pays / ea
$2.2752
gross reimbursed
vs
NADAC / ea
$2.0310
acquisition cost
=
Spread
+$0.2442
+12% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
56% FFS 44% MCO
Fee-for-service · 44 Rx Managed care · 34 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 1,454 units · 7.4 per 100k residents 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: 1,009 units · 7.8 per 100k residents 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: no data reported 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
7.47.8
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Pennsylvania 7.8 /100k
2 New York 7.4 /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.
15 pouches59088-0396-82 88 Rx · $4,212
30 pouches this page59088-0396-54 78 Rx · $5,604
Drug total (last 4 qtrs): 166 Rx · 4,097 units · $9,816 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Lidocaine — the program that covers self-administered drugs. 17 manufacturers.
⚠️ 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 Lidocaine. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$53.12M
Claims incl. refills
593.7K
Beneficiaries
367.9K
Spend / beneficiary
$144.39
Spend / claim
$89.46
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 Lidocaine — the ingredient across all brands.

Top reported reactions

Pain5,190
Nausea4,961
Fatigue4,867
Headache4,439
Product Quality Issue3,920
Dyspnoea3,658
Product Adhesion Issue3,514

Age at onset

Neonate191
Infant95
Child490
Adolescent342
Adult7,266
Elderly4,622

Reporter sex

96,036 reports
Male · 33%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization26,850
Death7,429
Life-threatening6,105
Disabling2,002
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 7,424 0
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 NDCDescription Per unit Per pack Marketing startStatus
59088-0396-54 You're viewing this 30 POUCH in 1 CARTON (59088-396-54) / .7 g in 1 POUCH (59088-396-84) $2.03 / ea $60.93 2016-02-29 Discontinued by firm
59088-0396-82 15 POUCH in 1 CARTON (59088-396-82) / .7 g in 1 POUCH (59088-396-84) $2.03 / ea $30.47 2016-02-29 Discontinued by firm

This pack has the lowest per-ea cost of the 2 priced pack sizes ($2.03 NADAC).

This pack accounts for about 47% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 59088-0396-54?
NDC 59088-0396-54 contains 30 pouches — 30 pouch in 1 carton / .7 g in 1 pouch.
What is the difference between NDC 59088-0396-54 and NDC 59088-0396-82?
Both are Lidocaine 50 mg/g Patch — the drug itself is identical. NDC 59088-0396-54 is the 30 pouches package, while NDC 59088-0396-82 is the 15 pouches package.
What NDC number is used to bill for this package of Lidocaine 50 mg/g Patch?
Bill NDC 59088-0396-54 — the 11-digit billing format is 59088039654. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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) ✓ Available
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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 59088-396-54, 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: 59088-0396-54, written without dashes as 59088039654. 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 59088-0396-54, the first segment (59088) is the labeler code FDA assigned to PureTek Corporation; the middle segment (0396) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (54) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 15 pouches (59088-0396-82). 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?
PureTek Corporation 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

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🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 24 words ▾

INDICATION AND USAGE Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.

⏱️ Dosage and Administration 145 words ▾

DOSAGE AND ADMINISTRATION Apply lidocaine patch 5% to intact skin to cover the most painful area. Apply the prescribed number of patches (maximum of 3), only once for up to 12 hours within a 24-hour period. Patches may be cut into smaller sizes with scissors prior to removal of the release liner.

(See HANDLING AND DISPOSAL ) Clothing may be worn over the area of application. Smaller areas of treatment are recommended in a debilitated patient, or a patient with impaired elimination. If irritation or a burning sensation occurs during application, remove the patch(es) and do not reapply until the irritation subsides.

When lidocaine patch 5% is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered. Lidocaine patch 5% may not stick if it gets wet. Avoid contact with water, such as bathing, swimming or showering.

⛔ Contraindications 29 words ▾

CONTRAINDICATIONS Lidocaine patch 5% is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product.

⚠️ Warnings 208 words ▾

WARNINGS Accidental Exposure in Children Even a used lidocaine patch contains a large amount of lidocaine (at least 665 mg). The potential exists for a small child or a pet to suffer serious adverse effects from chewing or ingesting a new or used lidocaine patch, although the risk with this formulation has not been evaluated. It is important for patients to store and dispose of lidocaine patch 5% out of the reach of children, pets and others.

(See HANDLING AND DISPOSAL ) Excessive Dosing Excessive dosing by applying lidocaine patch 5% to larger areas or for longer than the recommended wearing time could result in increased absorption of lidocaine and high blood concentrations, leading to serious adverse effects (see ADVERSE REACTIONS , Systemic Reactions ). Lidocaine toxicity could be expected at lidocaine blood concentrations above 5 mcg/mL. The blood concentration of lidocaine is determined by the rate of systemic absorption and elimination.

Longer duration of application, application of more than the recommended number of patches, smaller patients, or impaired elimination may all contribute to increasing the blood concentration of lidocaine. With recommended dosing of lidocaine patch 5%, the average peak blood concentration is about 0.13 mcg/mL, but concentrations higher than 0.25 mcg/mL have been observed in some individuals.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Application Site Reactions During or immediately after treatment with lidocaine patch 5%, the skin at the site of application may develop blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia, pruritus, vesicles, or may be the locus of abnormal sensation. These reactions are generally mild and transient, resolving spontaneously within a few minutes to hours. Allergic Reactions Allergic and anaphylactoid reactions associated with lidocaine, although rare, can occur.

They are characterized by angioedema, bronchospasm, dermatitis, dyspnea, hypersensitivity, laryngospasm, pruritus, shock, and urticaria. If they occur, they should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.

Other Adverse Events Due to the nature and limitation of spontaneous reports in postmarketing surveillance, causality has not been established for additional reported adverse events including: Asthenia, confusion, disorientation, dizziness, headache, hyperesthesia, hypoesthesia, lightheadedness, metallic taste, nausea, nervousness, pain exacerbated, paresthesia, somnolence, taste alteration, vomiting, visual disturbances such as blurred vision, flushing, tinnitus, and tremor. Systemic (Dose-Related) Reactions Systemic adverse reactions following appropriate use of lidocaine patch 5% are unlikely, due to the small dose absorbed (see CLINICAL PHARMACOLOGY , Pharmacokinetics ).

Systemic adverse effects of lidocaine are similar in nature to those observed with other amide local anesthetic agents, including CNS excitation and/or depression (light-headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest). Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness.

Cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest. To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch for voluntary reporting of adverse reactions.

🔄 Drug Interactions 58 words ▾

Drug Interactions Antiarrhythmic Drugs: Lidocaine patch 5% should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. Local Anesthetics: When lidocaine patch 5% is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.

🤰 Pregnancy 78 words ▾

Pregnancy Teratogenic Effects: Pregnancy Category B. Lidocaine patch 5% has not been studied in pregnancy. Reproduction studies with lidocaine have been performed in rats at doses up to 30 mg/kg subcutaneously and have revealed no evidence of harm to the fetus due to lidocaine.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, lidocaine patch 5% should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 12 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🆘 Overdosage 155 words ▾

OVERDOSAGE Lidocaine overdose from cutaneous absorption is rare, but could occur. If there is any suspicion of lidocaine overdose (see ADVERSE REACTIONS , Systemic Reactions ), drug blood concentration should be checked. The management of overdose includes close monitoring, supportive care, and symptomatic treatment.

Dialysis is of negligible value in the treatment of acute overdose with lidocaine. In the absence of massive topical overdose or oral ingestion, evaluation of symptoms of toxicity should include consideration of other etiologies for the clinical effects, or overdosage from other sources of lidocaine or other local anesthetics. The oral LD 50 of lidocaine HCl is 459 (346 to 773) mg/kg (as the salt) in non-fasted female rats and 214 (159 to 324) mg/kg (as the salt) in fasted female rats, which are equivalent to roughly 4000 mg and 2000 mg, respectively, in a 60 to 70 kg man based on the equivalent surface area dosage conversion factors between species.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Pharmacodynamics Lidocaine is an amide-type local anesthetic agent and is suggested to stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses. The penetration of lidocaine into intact skin after application of lidocaine patch is sufficient to produce an analgesic effect, but less than the amount necessary to produce a complete sensory block. Pharmacokinetics Absorption: The amount of lidocaine systemically absorbed from lidocaine patch is directly related to both the duration of application and the surface area over which it is applied.

In a pharmacokinetic study, three lidocaine patches were applied over an area of 420 cm 2 of intact skin on the back of normal volunteers for 12 hours. Blood samples were withdrawn for determination of lidocaine concentration during the application and for 12 hours after removal of patches. The results are summarized in Table 1.

Table 1: Absorption of lidocaine from Lidocaine Patch Normal volunteers (n = 15, 12-hour wearing time) Lidocaine Patch Application Site Area (cm 2 ) Dose Absorbed (mg) C max (mcg/mL) T max (hr) 3 patches (2100 mg) Back 420 64 ± 32 0.13 ± 0.06 11 hr When lidocaine patch is used according to the recommended dosing instructions, only 3 ± 2% of the dose applied is expected to be absorbed. At least 95% (665 mg) of lidocaine will remain in a used patch. Mean peak blood concentration of lidocaine is about 0.13 mcg/mL (about 1/10 of the therapeutic concentration required to treat cardiac arrhythmias).

Repeated application of three patches simultaneously for 12 hours (recommended maximum daily dose), once per day for three days, indicated that the lidocaine concentration does not increase with daily use. The mean plasma pharmacokinetic profile for the 15 healthy volunteers is shown in Figure 1. Figure 1: Mean lidocaine blood concentrations after three consecutive daily applications of three lidocaine patches simultaneously for 12 hours per day in healthy volunteers (n = 15). image description Distribution: When lidocaine is administered intravenously to healthy volunteers, the volume of distribution is 0.7 to

2.7L/kg (mean 1.5 ±

0.6SD, n = 15). At concentrations produced by application of lidocaine patch, lidocaine is approximately 70% bound to plasma proteins, primarily alpha-1-acid glycoprotein. At much higher plasma concentrations (1 to 4 mcg/mL of free base), the plasma protein binding of lidocaine is concentration dependent.

Lidocaine crosses the placental and blood brain barriers, presumably by passive diffusion. Metabolism: It is not known if lidocaine is metabolized in the skin. Lidocaine is metabolized rapidly by the liver to a number of metabolites, including monoethylglycinexylidide (MEGX) and glycinexylidide (GX), both of which have pharmacologic activity similar to, but less potent than that of lidocaine.

A minor metabolite, 2, 6-xylidine, has unknown pharmacologic activity but is carcinogenic in rats. The blood concentration of this metabolite is negligible following application of lidocaine patch 5%. Following intravenous administration, MEGX and GX concentrations in serum range from 11 to 36% and from 5 to 11% of lidocaine concentrations, respectively.

Excretion: Lidocaine and its metabolites are excreted by the kidneys. Less than 10% of lidocaine is excreted unchanged. The half-life of lidocaine elimination from the plasma following IV administration is 81 to 149 minutes (mean 107 ± 22 SD, n = 15).

The systemic clearance is 0.33 to

0.90L/min (mean 0.64 ±

0.18SD, n = 15).

📦 How Supplied / Storage and Handling 81 words ▾

HOW SUPPLIED Lidocaine patch 5% is available as the following: Carton of 15 patches, NDC 59088-396-82 Carton of 30 patches, NDC 59088-396-54 Each patch is packaged into an individual child-resistant envelope. Store at 20 o to 25 o C (68 o to 77 o F) [See USP Controlled Room Temperature]. For more information, call Actavis at 1-800-272-5525.

Manufactured by: Actavis Laboratories UT, Inc. Salt Lake City, UT 84108 USA Distributed by: PureTek Corporation San Fernando, CA 91340 USA Rev. 37780 02/16

📋 Description 127 words ▾

DESCRIPTION Lidocaine patch 5% is comprised of an adhesive material containing 5% lidocaine, which is applied to a white non-woven polyethylene terephthalate (PET) material backing and covered with a transparent PET release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm.

Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure: Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: glycerin, D-sorbitol, propylene glycol, polyvinyl alcohol, urea, sodium polyacrylate, carboxymethylcellulose sodium, gelatin, polyacrylic acid, kaolin, tartaric acid, dihydroxyaluminum aminoacetate, methylparaben, propylparaben, and edetate disodium. image description

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