HomeNDC LookupIngredientsLidocaine Hydrochloride › 63323-0201-10
Lidocaine 10 mg/mL Injection, Solution — NDC 63323-0201-10 package photo

Lidocaine 10 mg/mL Injection, Solution

by Fresenius Kabi USA, LLC · 25 VIAL in 1 TRAY (63323-201-10) / 10 mL in 1 VIAL (63323-201-03)
NDC 63323-0201-10
🏷️ FDA NDC (as labeled) 63323-201-10 billing pads the product segment with a zero
This package
Contains10 mL in 1 vial Cost per mL$0.1378 NADAC Per package$34.45 / 250 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $5.47/unit — full pricing hub ↓
Also comes in: 25 vials 63323-0201-02
Rx only Generic On market Non-controlled ⚠ On shortage
🗂️ 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 →
⚠️
Active FDA shortage. Lidocaine Hydrochloride Injection is currently reported in shortage by the FDA (Demand increase for the drug). Unavailable Shortage details →
⚠️
Other active recalls for Lidocaine Hydrochloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 16, 2026 — Presence of Particulate Matter: Hair was found in products (Fresenius Kabi USA, LLC) · FDA recall D-0726-2026
Class II · Jun 8, 2026 — Lack of Assurance of Sterility (Asclemed USA Inc.) · FDA recall D-0658-2026
Class II · Apr 2, 2026 — Lack of Assurance of Sterility (Huons Co., Ltd.) · FDA recall D-0529-2026
Class II · Apr 2, 2026 — Lack of Assurance of Sterility (Huons Co., Ltd.) · FDA recall D-0532-2026
Class II · Nov 30, 2021 — Superpotent Drug: Minimally superpotent (Teligent Pharma, Inc.) · FDA recall D-0296-2022
Class I · Nov 30, 2021 — Superpotent Drug (Teligent Pharma, Inc.) · FDA recall D-0295-2022
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 63323-201-10
Product NDC 63323-201
11-digit billing NDC 63323020110
NCPDP billing unit ML — per mL (volume)
RxCUI 1010033, 1737757
UNII V13007Z41A
UPC 0363323202019, 0363323201036, 0363323201012
Application # ANDA088586
SPL Set ID cddb2b22-fce3-8967-6e54-dca3df5ac4b3
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-05-27
Route INFILTRATION, PERINEURAL
Dosage form INJECTION, SOLUTION
Substance LIDOCAINE HYDROCHLORIDE
GPI-14 69100040102010
GPI class Lidocaine HCl
GCN Seq No 003404
GCN 11854
HICL code 001478
Ingredient (HICL) Lidocaine Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H0
Therapeutic class — intermediate (HIC2) Act On Non-Autonomic Nervous System
HIC3 code H0A
Therapeutic class — specific (HIC3) Local Anesthetics
AHFS code 24:04.04.08
AHFS class Class Ib Antiarrhythmics
FDB label name LIDOCAINE HCL 1% VIAL
FDB brand name Lidocaine Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 63323-201-10 — 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 → 63323-0201-10. 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

LabelerFresenius Kabi USA, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationANDA088586 (ANDA)
Labeler code63323
First marketedMay 2010
Product typeHuman Prescription Drug
Portfolio554 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 HCL 1% VIAL Ingredient Lidocaine Hcl
📗 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 mLPer package
Retail pharmacies payNADAC · weekly $0.138 $34.45 / 250 ml
Medicaid paysCMS SDUD · 12 mo $5.47 $1,368.28 / 250 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J2003 No ASP payment limit on file for J2003 this quarter.
NADAC price history (per mL) — tap or hover for the price & month
Mar 2023 Feb 2026 May 2026 Aug 2026 $0.194 $0.120
▼ Down 29% over the last 10 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.

🧾 Billing & reimbursement

FDA NDC (as labeled)63323-201-10
11-digit billing NDC63323-0201-10
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ2003
DescriptorINJECTION, LIDOCAINE HYDROCHLORIDE, 1 MG
Billing units / pkg10 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lidocaine Hydrochloride 10 mg/mL 55150-0253-50 Eugia 25 vials $0.054 AP Availability likely save 61%
Lidocaine hydrochloride 10 mg/mL 72603-0732-25 NorthStar 25 vials $0.054 AP Availability likely save 61%
Lidocaine 10 mg/mL 00143-9577-10 Hikma 10 vials $0.069 AP Availability likely save 50%
Lidocaine Hydrochloride 10 mg/mL 00409-4276-01 Hospira, 25 vials $0.069 AP Availability likely save 50%
Lidocaine Hydrochloride 10 mg/mL 23155-0940-41 Heritage 25 vials $0.069 AP Availability likely save 50%
Lidocaine hydrochloride 10 mg/mL 31722-0116-31 Camber 25 vials $0.069 AP Availability likely save 50%
Lidocaine Hydrochloride 10 mg/mL 55150-0252-20 Eugia 25 vials $0.069 AP Availability likely save 50%
Lidocaine hydrochloride 10 mg/mL 72603-0722-25 NorthStar 25 vials $0.069 AP Availability likely save 50%
Lidocaine Hydrochloride 10 mg/mL 55150-0251-10 Eugia 25 vials $0.138 AP Availability likely
Lidocaine 10 mg/mLthis 63323-0201-10 Fresenius 25 vials $0.138 AP Availability likely
Lidocaine Hydrochloride 10 mg/mL 70756-0645-25 Lifestar 25 vials $0.138 AP Availability likely
Lidocaine 10 mg/mL 00143-9172-10 Hikma 10 vials AP FDA listed
Lidocaine 10 mg/mL 00143-9578-10 Hikma 10 vials AP FDA listed
Lidocaine 10 mg/mL 00143-9579-25 Hikma 25 vials AP FDA listed
Lidocaine Hydrochloride 10 mg/mL 00404-9763-20 Henry 1 vial AP FDA listed
Lidocaine Hydrochloride 10 mg/mL 00404-9798-50 Henry 1 vial AP FDA listed
Lidocaine Hydrochloride 10 mg/mL 00404-9888-20 Henry 1 vial AP FDA listed
Xylocaine 10 mg/mL 00404-9973-20 Henry 1 vial AP FDA listed
Lidocaine Hydrochloride 10 mg/mL 50090-0258-01 A-S 25 vials AP FDA listed
1% Lidocaine Hci 10 mg/mL 51662-1465-01 HF 20 ml AP FDA listed
1% Lidocaine Hci 10 mg/mL 51662-1466-01 HF 50 ml AP FDA listed
XYLOCAIN (LIDOCAINE HCl ) 10 mg/mL 51662-1587-03 HF 25 pouches AP FDA listed
Xylocaine 20 mg/mL 51662-1590-03 HF 25 pouches AP FDA listed
Xylocaine 10 mg/mL 51662-1591-03 HF 25 pouches AP FDA listed
Lidocaine Hydrochloride 10 mg/mL 55154-0124-05 Cardinal 5 vials AP Discontinued
Lidocaine Hydrochloride 10 mg/mL 55154-8337-05 Cardinal 5 vials AP FDA listed
Xylocaine 10 mg/mL 63323-0485-26 Fresenius 25 vials AP FDA listed
Lidocaine Hydrochloride 10 mg/mL 70756-0644-25 Lifestar 25 vials AP FDA listed
Lidocaine Hydrochloride 10 mg/mL 70756-0646-05 Lifestar 5 vials AP FDA listed
Lidocaine Hydrochloride 10 mg/mL 70756-0666-10 Lifestar 10 vials AP FDA listed
Lidocaine Hydrochloride 10 mg/mL 71351-0026-25 Brookfield 25 vials AP FDA listed
Lidocaine Hydrochloride 10 mg/mL 71872-7137-01 Medical 1 vial AP FDA listed
Lidocaine 10 mg/mL 71872-7158-01 Medical 1 vial AP FDA listed
Lidocaine Hydrochloride 10 mg/mL 71872-7184-01 Medical 1 vial AP FDA listed
Lidocaine Hydrochloride 10 mg/mL 71872-7254-01 Medical 1 vial AP FDA listed
Lidocaine Hydrochloride 10 mg/mL 71872-7315-01 Medical 1 vial AP FDA listed
lidocaine hydrochloride 10 mg/mL 71872-7362-01 Medical 1 vial AP FDA listed
Lidocaine Hydrochloride 10 mg/mL 73293-0004-02 Huons 10 vials AP FDA listed
lidocaine hydrochloride 10 mg/mL 83634-0651-10 Avenacy, 25 vials AP FDA listed
Lidocaine Hydrochloride 10 mg/mL 83854-0009-25 Anthea 25 vials AP FDA listed
Lidocaine Hydrochloride 10 mg/mL 84549-0276-02 ProPharma 50 ml AP FDA listed
Lidocaine 10 mg/mL 85766-0063-25 Sportpharm 25 vials AP 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

🏛️
2010
On the market since
May 2010
📍
2026
Currently FDA-listed
16 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 63323-0201-10, 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
18.8K
Units reimbursed last 4 qtrs
143.7K
Gross reimbursed last 4 qtrs
$786.7K
Avg / prescription
$41.84
Avg / unit
$5.4731
Latest quarter Q1 2026
3.6KRx
Medicaid pays / mL
$5.4731
gross reimbursed
vs
NADAC / mL
$0.1378
acquisition cost
=
Spread
+$5.3353
+3872% vs cost
What Medicaid paid per mL (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
18% FFS 82% MCO
Fee-for-service · 3,377 Rx Managed care · 15,423 Rx
State Medicaid map
Alaska: no data reported AK Maine: 140 units · 10.0 per 100k residents ME Washington: 907 units · 11.6 per 100k residents WA Idaho: 3,375 units · 172 per 100k residents ID Montana: 527 units · 46.6 per 100k residents MT North Dakota: 1,109 units · 142 per 100k residents ND Minnesota: 7,530 units · 131 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 4,057 units · 20.7 per 100k residents NY Vermont: no data reported VT New Hampshire: 1,495 units · 107 per 100k residents NH Oregon: 518 units · 12.2 per 100k residents OR Nevada: 565 units · 17.7 per 100k residents NV Wyoming: no data reported WY South Dakota: 13,288 units · 1,446 per 100k residents SD Iowa: 2,378 units · 74.2 per 100k residents IA Illinois: 285 units · 2.3 per 100k residents IL Indiana: 223 units · 3.2 per 100k residents IN Ohio: 3,395 units · 28.8 per 100k residents OH Pennsylvania: 2,897 units · 22.4 per 100k residents PA New Jersey: 3,216 units · 34.6 per 100k residents NJ Massachusetts: 13,855 units · 198 per 100k residents MA California: 20,180 units · 51.8 per 100k residents CA Utah: 18 units · 0.5 per 100k residents UT Colorado: no data reported CO Nebraska: 1,359 units · 68.7 per 100k residents NE Missouri: 7,576 units · 122 per 100k residents MO Kentucky: 12,045 units · 266 per 100k residents KY West Virginia: no data reported WV Virginia: 1,291 units · 14.8 per 100k residents VA Maryland: 611 units · 9.9 per 100k residents MD Connecticut: 397 units · 11.0 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 3,180 units · 150 per 100k residents NM Kansas: 1,067 units · 36.3 per 100k residents KS Arkansas: no data reported AR Tennessee: 14,825 units · 208 per 100k residents TN North Carolina: 3,299 units · 30.4 per 100k residents NC South Carolina: no data reported SC Delaware: 2,140 units · 208 per 100k residents DE Oklahoma: 4,591 units · 113 per 100k residents OK Louisiana: 4,206 units · 92.0 per 100k residents LA Mississippi: 543 units · 18.5 per 100k residents MS Alabama: 320 units · 6.3 per 100k residents AL Georgia: 34 units · 0.3 per 100k residents GA D.C.: 925 units · 136 per 100k residents DC Hawaii: no data reported HI Texas: 300 units · 1.0 per 100k residents TX Florida: 3,384 units · 15.0 per 100k residents FL
Units reimbursed · per 100k residents
0.31,446
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 South Dakota 1,446 /100k
2 Kentucky 266 /100k
3 Tennessee 208 /100k
4 Delaware 208 /100k
5 Massachusetts 198 /100k
6 Idaho 172 /100k
7 New Mexico 150 /100k
8 North Dakota 142 /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.
25 vials this page63323-0201-10 18,800 Rx · $786,668
25 vials63323-0201-02 2,621 Rx · $87,899
Drug total (last 4 qtrs): 21,421 Rx · 164,808 units · $874,567 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 (this brand).

Top reported reactions

Nausea3,531
Pain3,515
Fatigue3,397
Headache3,246
Dyspnoea2,599
Diarrhoea2,360
Pneumonia2,176

Reporter sex

55,625 reports
Male · 37%
Female · 63%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5,645 2,754
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
63323-0201-10 You're viewing this 25 VIAL in 1 TRAY (63323-201-10) / 10 mL in 1 VIAL (63323-201-03) $0.1378 / mL $34.46 2010-05-27 Active
63323-0201-02 25 VIAL in 1 TRAY (63323-201-02) / 2 mL in 1 VIAL (63323-201-01) 2010-05-27 Active

In Medicaid, this is the most-dispensed pack of this product — about 88% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 63323-0201-10?
NDC 63323-0201-10 is listed by the FDA — 25 vial in 1 tray / 10 ml in 1 vial.
What NDC number is used to bill for this package of Lidocaine 10 mg/mL Injection, Solution?
Bill NDC 63323-0201-10 — the 11-digit billing format is 63323020110. 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.

📄 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 48 words

INDICATIONS AND USAGE Lidocaine Hydrochloride Injection, USP is indicated for the production of local anesthesia, by infiltration techniques, such as percutaneous injection, and by peripheral nerve block techniques, such as brachial plexus and inter-costal, when the accepted procedures for these techniques as described in standard textbooks are observed.

⏱️ Dosage and Administration ~1 min read

DOSAGE AND ADMINISTRATION Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of lidocaine hydrochloride injection for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrine-free solutions. When larger volumes are required, only solutions containing epinephrine should be used, except in those cases where vasopressor drugs may be contraindicated.

There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. Lidocaine is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION ). These recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures.

The actual volumes and concentrations to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia and degree of muscular relaxation required, duration of anesthesia required and the physical condition of the patient. In all cases the lowest concentration and smallest dose that will produce the desired result should be given. Dosages should be reduced for children and for elderly and debilitated patients and patients with cardiac and/or liver disease.

The onset of anesthesia, the duration of anesthesia and the degree of muscular relaxation are proportional to the volume and concentration (i.e. total dose) of local anesthetic used. Thus, an increase in volume and concentration of lidocaine hydrochloride injection will decrease the onset of anesthesia, prolong the duration of anesthesia, provide a greater degree of muscular relaxation and increase the segmental spread of anesthesia. However, increasing the volume and concentration of lidocaine hydrochloride injection may result in a more profound fall in blood pressure when used in epidural anesthesia.

Although the incidence of side effects with lidocaine is quite low, caution should be exercised when employing large volumes and concentrations, since the incidence of side effects is directly proportional to the total dose of local anesthetic agent injected.

Contraindications 20 words

CONTRAINDICATIONS Lidocaine HCl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

⚠️ Warnings ~1 min read

WARNINGS LIDOCAINE HYDROCHLORIDE INJECTION FOR INFILTRATION AND NERVE BLOCK SHOULD BE EMPLOYED ONLY BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE EMERGENCIES THAT MIGHT ARISE FROM THE BLOCK TO BE EMPLOYED AND THEN ONLY AFTER ENSURING THE IMMEDIATE AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY EQUIPMENT AND THE PERSONNEL NEEDED FOR PROPER MANAGEMENT OF TOXIC REACTIONS AND RELATED EMERGENCIES (see also ADVERSE REACTIONS and PRECAUTIONS ). DELAY IN PROPER MANAGEMENT OF DOSE-RELATED TOXICITY, UNDERVENTILATION FROM ANY CAUSE AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF ACIDOSIS, CARDIAC ARREST AND, POSSIBLY, DEATH.

Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions. The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humeral chondrolysis have been described in pediatric and adult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods are not associated with these findings.

The time of onset of symptoms, such as joint pain, stiffness and loss of motion can be variable, but may begin as early as the 2nd month after surgery. Currently, there is no effective treatment for chondrolysis; patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement. To avoid intravascular injection, aspiration should be performed before the local anesthetic solution is injected.

The needle must be repositioned until no return of blood can be elicited by aspiration. Note, however, that the absence of blood in the syringe does not guarantee that intravascular injection has been avoided. Local anesthetic solutions containing antimicrobial preservatives (e.g., methylparaben) should not be used for epidural or spinal anesthesia because the safety of these agents has not been established with regard to intrathecal injection, either intentional or accidental.

🤒 Adverse Reactions ~3 min read

ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Systemic Adverse experiences following the administration of lidocaine HCl are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption or inadvertent intravascular injection, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient.

Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported: Central Nervous System CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, 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. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest.

Drowsiness following the administration of lidocaine HCl is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption. Cardiovascular System Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest. Allergic Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions.

Allergic reactions may occur as a result of sensitivity either to local anesthetic agents or to the methylparaben used as a preservative in the multiple dose vials. Allergic reactions as a result of sensitivity to lidocaine HCl are extremely rare and, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.

Neurologic The incidences of adverse reactions associated with the use of local anesthetics may be related to the total dose of local anesthetic administered and are also dependent upon the particular drug used, the route of administration and the physical status of the patient. In a prospective review of 10,440 patients who received lidocaine HCl for spinal anesthesia, the incidences of adverse reactions were reported to be about 3% each for positional headaches, hypotension and backache; 2% for shivering; and less than 1% each for peripheral nerve symptoms, nausea, respiratory inadequacy and double vision.

Many of these observations may be related to local anesthetic techniques, with or without a contribution from the local anesthetic. There have been reported cases of permanent injury to extraocular muscles requiring surgical repair following retrobulbar administration.

Systemic Adverse experiences following the administration of lidocaine HCl are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption or inadvertent intravascular injection, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature.

The following types are those most commonly reported:

Central Nervous System CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, 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. The excitatory manifestations may be very brief or may not occur at all, in which…

🆘 Overdosage ~3 min read

OVERDOSAGE 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 (see ADVERSE REACTIONS , WARNINGS and PRECAUTIONS ). Management of Local Anesthetic Emergencies The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic injection.

At the first sign of change, oxygen should be administered. The first step in the management of convulsions, as well as underventilation or apnea due to unintended subarachnoid injection of drug solution, consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously.

Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously. The clinician should be familiar, prior to the use of local anesthetics, with these anticonvulsant drugs. Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor as directed by the clinical situation (e.g., ephedrine).

If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. Underventilation or apnea due to unintentional subarachnoid injection of local anesthetic solution may produce these same signs and also lead to cardiac arrest if ventilatory support is not instituted. If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted.

Endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated, after initial administration of oxygen by mask, if difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated. Dialysis is of negligible value in the treatment of acute overdosage with lidocaine HCl. The oral LD 50 of lidocaine HCl in non-fasted female rats is 459 (346 to 773) mg/kg (as the salt) and 214 (159 to 324) mg/kg (as the salt) in fasted female rats.

Management of Local Anesthetic Emergencies The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic injection. At the first sign of change, oxygen should be administered. The first step in the management of convulsions, as well as underventilation or apnea due to unintended subarachnoid injection of drug solution, consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask.

Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously. Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously. The clinician should be familiar, prior to the use of loca…

🧬 Clinical Pharmacology ~3 min read

CLINICAL PHARMACOLOGY Mechanism of Action Lidocaine HCl stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. Hemodynamics Excessive blood levels may cause changes in cardiac output, total peripheral resistance, and mean arterial pressure. With central neural blockade these changes may be attributable to block of autonomic fibers, a direct depressant effect of the local anesthetic agent on various components of the cardiovascular system.

The net effect is normally a modest hypotension when the recommended dosages are not exceeded. Pharmacokinetics and Metabolism Information derived from diverse formulations, concentrations and usages reveals that lidocaine HCl is completely absorbed following parenteral administration, its rate of absorption depending, for example, upon various factors such as the site of administration and the presence or absence of a vasoconstrictor agent. Except for intravascular administration, the highest blood levels are obtained following intercostal nerve block and the lowest after subcutaneous administration.

The plasma binding of lidocaine HCl is dependent on drug concentration, and the fraction bound decreases with increasing concentration. At concentrations of 1 to 4 mcg of free base/mL, 60 to 80% of lidocaine HCl is protein bound. Binding is also dependent on the plasma concentration of the alpha-1-acid glycoprotein.

Lidocaine HCl crosses the blood-brain and placental barriers, presumably by passive diffusion. Lidocaine HCl 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 pharmacological/toxicological actions of these metabolites are similar to, but less potent than, those of lidocaine HCl. Approximately 90% of lidocaine HCl 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. The elimination half-life of lidocaine HCl following an intravenous bolus injection is typically 1.5 to 2 hours. Because of the rapid rate at which lidocaine HCl is metabolized, any condition that affects liver function may alter lidocaine kinetics.

The half-life may be prolonged two-fold or more in patients with liver dysfunction. Renal dysfunction does not affect lidocaine HCl kinetics but may increase the accumulation of metabolites. Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels of lidocaine HCl required to produce overt systemic effects.

Objective adverse manifestations become increasingly apparent with increasing venous plasma levels above 6 mcg free base/mL. In the rhesus monkey arterial blood levels of 18 to 21 mcg/mL have been shown to be threshold for convulsive activity.

Mechanism of Action Lidocaine HCl stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action.

Hemodynamics Excessive blood levels may cause changes in cardiac output, total peripheral resistance, and mean arterial pressure. With central neural blockade these changes may be attributable to block of autonomic fibers, a direct depressant effect of the local anesthetic agent on various components of the cardiovascular system. The net effect is normally a modest hypotension when the recommended dosages are not exceeded.

Pharmacokinetics and Metabolism Information derived from diverse formulations, concentrations and usages reveals that lidocaine HCl is completely absorbed following parenteral administration, its rate of absorption depending, for example, upon various factors…

📦 How Supplied / Storage and Handling 105 words

HOW SUPPLIED Lidocaine Hydrochloride Injection is preserved with 0.1% methylparaben and is available in the following concentrations: Product Code Unit of Sale Strength Each 920102 NDC 63323-201-02 Unit of 25 1% 20 mg per 2 mL (10 mg per mL) NDC 63323-201-01 2 mL Vial 20110 NDC 63323-201-10 Unit of 25 1% 100 mg per 10 mL (10 mg per mL) NDC 63323-201-03 10 mL Multiple Dose Vial 20202 NDC 63323-202-02 Unit of 25 2% 40 mg per 2 mL (20 mg per mL) NDC 63323-202-01 2 mL Vial Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from light.

📋 Description 103 words

DESCRIPTION Lidocaine Hydrochloride Injection, USP is a local anesthetic which is a sterile, nonpyrogenic solution intended for parenteral injection. See INDICATIONS AND USAGE for specific uses. Lidocaine hydrochloride is chemically designated as 2-(Diethylamino) 2’,6’ acetoxylidide monohydrochloride and has the following structural formula: C 14 H 22 N 2 O • HCl M.W.

288.82 Each mL contains: Lidocaine hydrochloride 10 or 20 mg; methylparaben 0.1%; sodium chloride (7 mg and 6 mg of sodium chloride for 1% and 2% respectively) to render it isotonic; Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.0). structure

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