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Lidocaine 20 mg/mL Injection, Solution — NDC 63323-0208-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Lidocaine 20 mg/mL Injection, Solution — NDC 63323-208-05 (Billing 63323-0208-05)

by Fresenius Kabi USA, LLC · 25 VIAL, SINGLE-DOSE in 1 TRAY / 5 mL in 1 VIAL, SINGLE-DOSE

This is a package of Lidocaine 20 mg/mL Injection, Solution from Fresenius Kabi USA, LLC, marketed since Sep 2000 and currently FDA-listed. It is this product's only package size.

NDC 63323-0208-05
🏷️ FDA NDC (as labeled) 63323-208-05 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⚠ On shortage ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 63323-208-05 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63323 labeler · 208 product · 05 package
Package marketed since
Sep 5, 2000
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0363323208011
Medicaid fills, this package
17,568 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Active FDA shortage. Lidocaine Hydrochloride Injection is currently reported in shortage by the FDA (Demand increase for the drug). Unavailable Shortage details →
🚨
Active recall for this product.
Class II · Jul 16, 2026 — Presence of Particulate Matter: Hair was found in products (Fresenius Kabi USA, LLC) · FDA recall D-0726-2026
Lots / codes: Lot #: 6133801, Exp. Date 01/2028 · reported Jul 29, 2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Other active recalls for Lidocaine Hydrochloride (different manufacturers) — 5 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63323-208-05
Product NDC 63323-208
11-digit billing NDC 63323020805
NCPDP billing unit ML — per mL (volume)
RxCUI 1737761
UNII V13007Z41A
UPC 0363323208011
Application # NDA017584
SPL Set ID f1b26274-a55e-4321-b96c-ce0df830f205
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 2000-09-05
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance LIDOCAINE HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS

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

GPI-14 35200020102035
GPI class Lidocaine HCl (Cardiac) PF
GCN Seq No 061634
GCN 97420
HICL code 033592
Ingredient (HICL) Lidocaine Hcl/Pf
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A2
Therapeutic class — intermediate (HIC2) Cardiac Depressants
HIC3 code A2A
Therapeutic class — specific (HIC3) Antiarrhythmics
AHFS code 24:04.04.08
AHFS class Class Ib Antiarrhythmics
FDB label name LIDOCAINE HCL 2% VIAL
FDB brand name Lidocaine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 061634
  • GCN: 97420
  • GPI-14 (Medi-Span): 35200020102035
  • HICL (First Databank): 033592
  • AHFS class code: 24:04.04.08
  • RxCUI (RxNorm): 1737761
Why two NDCs? The FDA registers this code as 63323-208-05 — 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 → 63323-0208-05. 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.

Clinical

Label name LIDOCAINE HCL 2% VIAL Ingredient Lidocaine Hcl/Pf
📖 What it is MedlinePlus · NLM

Lidocaine injection is used to treat arrhythmias (irregular heartbeats). Lidocaine injection is in a class of medications called antiarrhythmics. It works by acting on the heart muscle to improve the heart's rhythm.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Lidocaine numbs the area where it is used. Clinicians inject it for procedures. Skin products are used for pain, itching, minor burns, insect bites, hemorrhoid discomfort, and in s...
  • Clean and dry the skin first, then apply as your product’s directions say. Wash your hands afterward. Don’t exceed the number of uses on the label. Ask a doctor before using a prod...
  • No. Heat can increase how much lidocaine your body absorbs. Don’t bandage tightly either. Also avoid using other topical pain products at the same time.
  • Can I use a heating pad with a lidocaine patch?
📖 Read our full Lidocaine guide →

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.

Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $18.66 $2,332.99 / 125 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.
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)63323-208-05
11-digit billing NDC63323-0208-05
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 / pkg20 units
How the units are derivedThis package is 5 ML; the HCPCS unit is 1 MG, so one package = 20 billing 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63323-0208-05 You're viewing this Main listing 25 VIAL, SINGLE-DOSE in 1 TRAY / 5 mL in 1 VIAL, SINGLE-DOSE 2000-09-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lidocaine Hydrochloride 20 mg/mL 00409-2066-05 Hospira, 10 vials $0.349 AP Availability likely —
Lidocaine Hydrochloride 20 mg/mL 31722-0118-31 Camber 25 vials $0.349 AP Availability likely —
Lidocaine Hydrochloride 20 mg/mL 55150-0165-05 Eugia 10 vials $0.349 AP Availability likely —
Lidocaine Hydrochloride 20 mg/mL 72603-0505-10 NorthStar 10 vials $0.349 AP Availability likely —
Lidocaine Hydrochloride 20 mg/mL 00143-9594-25 Hikma 25 vials $0.363 AP Availability likely —
Lidocaine Hydrochloride 20 mg/mL 68094-0081-25 Precision 25 vials $0.363 AP Availability likely —
Lidocaine Hydrochloride 20 mg/mL 72572-0372-25 Civica, 25 vials $0.363 AP Availability likely —
Lidocaine Hydrochloride 20 mg/mL 00404-9897-05 Henry 1 vial — AP FDA listed —
Lidocaine Hci 20 mg/mL 51662-1233-01 HF 5 ml — AP FDA listed —
Lidocaine Hci 20 mg/mL 51662-1364-01 HF 5 ml — AP FDA listed —
Lidocaine Hci 20 mg/mL 51662-1422-01 HF 5 ml — AP FDA listed —
Lidocaine Hci 20 mg/mL 51662-1543-01 HF 5 ml — AP FDA listed —
XYLOCAINE- MPF (LIDOCAINE HCl ) 20 mg/mL 51662-1604-03 HF 25 pouches — AP FDA listed —
Lidocaine 20 mg/mLthis 63323-0208-05 Fresenius 25 vials — AP FDA listed —
Xylocaine MPF 20 mg/mL 63323-0495-26 Fresenius 25 vials — AP FDA listed —
Xylocaine MPF 20 mg/mL 65219-0814-05 Fresenius 25 vials — AP FDA listed —
Lidocaine Hydrochloride 20 mg/mL 70756-0643-10 Lifestar 10 vials — AP FDA listed —
Lidocaine Hydrochloride 20 mg/mL 71351-0023-10 Brookfield 10 vials — AP FDA listed —
Lidocaine Hydrochloride 20 mg/mL 71872-7144-01 Medical 1 vial — AP FDA listed —
Lidocaine Hydrochloride 20 mg/mL 71872-7161-01 Medical 1 vial — AP FDA listed —
Lidocaine Hydrochloride 20 mg/mL 71872-7357-01 Medical 1 vial — AP FDA listed —
Lidocaine Hydrochloride 20 mg/mL 73293-0003-02 Huons 10 vials — AP FDA listed —
Lidocaine Hydrochloride 20 mg/mL 76420-0078-05 Asclemed 5 ml — AP FDA listed —
Lidocaine Hydrochloride 20 mg/mL 76420-0540-05 Asclemed 5 ml — AP FDA listed —
Lidocaine Hydrochloride 20 mg/mL 83854-0012-25 Anthea 25 vials — AP FDA listed —
Lidocaine Hydrochloride 20 mg/mL 84549-0005-25 ProPharma 5 ml — AP FDA listed —
Lidocaine Hydrochloride 20 mg/mL 84549-0066-05 ProPharma 5 ml — AP FDA listed —
Lidocaine Hydrochloride 20 mg/mL 84549-0323-05 ProPharma 5 ml — AP FDA listed —
Lidocaine Hydrochloride 20 mg/mL 84769-0002-02 Novagenix 10 vials — AP FDA listed —
Lidocaine Hydrochloride 20 mg/mL 71872-7064-01 Medical 1 syringe — AP FDA listed —
Lidocaine Hydrochloride 20 mg/mL 71872-7126-01 Medical 1 syringe — AP FDA listed —
Lidocaine Hydrochloride 20 mg/mL 76329-3390-01 International 10 syringes — AP FDA listed —
Lidocaine Hydrochloride 20 mg/mL 51662-1454-01 HF 5 ml — — FDA listed —
Lidocaine Hydrochloride 20 mg/mL 55154-3189-05 Cardinal 5 syringes — AP FDA listed —
Lidocaine Hydrochloride 20 mg/mL 71351-0027-25 Brookfield 25 vials — AP FDA listed —
Lidocaine Hydrochloride 20 mg/mL 00409-1323-05 Hospira, 1 syringe — AP FDA listed —
Lidocaine Hydrochloride 20 mg/mL 73293-0005-02 Huons 10 vials — AP FDA listed —
Lidocaine Hydrochloride 20 mg/mL 70518-4176-00 REMEDYREPACK 10 syringes — AP FDA listed —
Lidocaine Hydrochloride 20 mg/mL 00404-9894-05 Henry 1 syringe — AP FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2000
On the market since
Sep 2000
📍
2026
Currently FDA-listed
26 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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

Inactive Ingredients / Excipients

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

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

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 6 mg / 1 mL 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.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerFresenius Kabi USA, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationNDA017584 (NDA)
Labeler code63323
First marketedSep 2000
Product typeHuman Prescription Drug
Portfolio554 products on file

More NDCs from Fresenius Kabi USA, LLC labeler code 63323

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 48 words ▾

INDICATIONS AND USAGE Lidocaine Hydrochloride Injection, USP administered intravenously is specifically indicated in the acute management of 1) ventricular arrhythmias occurring during cardiac manipulation such as cardiac surgery, and 2) life-threatening arrhythmias, particularly those which are ventricular in origin, such as those which occur during acute myocardial infarction.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Adult For Direct Injection –The usual dose is 50 to 100 mg administered intravenously under ECG monitoring. This dose may be administered at the rate of approximately 25 to 50 mg/min. Sufficient time should be allowed to enable a slow circulation to carry the drug to the site of action.

If the initial injection of 50 to 100 mg does not produce a desired response, a second dose may be repeated after 5 minutes. NO MORE THAN 200 TO 300 MG OF LIDOCAINE HYDROCHLORIDE INJECTION, USP SHOULD BE ADMINISTERED DURING A ONE HOUR PERIOD. This product is for DIRECT INJECTION ONLY.

For continuous infusion protocol, see prescribing information for lidocaine hydrochloride, USP for infusion solution. Pediatric Although controlled clinical studies to establish pediatric dosing schedules have not been conducted, the American Heart Association’s Standards and Guidelines recommends a bolus dose of 1 mg/kg followed by an infusion rate of 30 mcg/kg/min. This product is for DIRECT INJECTION ONLY .

For continuous infusion protocol, see prescribing information for lidocaine hydrochloride, USP for infusion solution. Sterilization, Storage and Technical Procedures It is recommended that chemical disinfection be accomplished by wiping the vial thoroughly with cotton or gauze that has been moistened with either 91% isopropyl alcohol or 70% ethyl alcohol, just prior to use. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Adult For Direct Injection –The usual dose is 50 to 100 mg administered intravenously under ECG monitoring. This dose may be administered at the rate of approximately 25 to 50 mg/min. Sufficient time should be allowed to enable a slow circulation to carry the drug to the site of action.

If the initial injection of 50 to 100 mg does not produce a desired response, a second dose may be repeated after 5 minutes. NO MORE THAN 200 TO 300 MG OF LIDOCAINE HYDROCHLORIDE INJECTION, USP SHOULD BE ADMINISTERED DURING A ONE HOUR PERIOD. This product is for DIRECT INJECTION ONLY.

For continuous infusion protocol, see prescribing information for lidocaine hydrochloride, USP for infusion solution.

Pediatric Although controlled clinical studies to establish pediatric dosing schedules have not been conducted, the American Heart Association’s Standards and Guidelines recommends a bolus dose of 1 mg/kg followed by an infusion rate of 30 mcg/kg/min. This product is for DIRECT INJECTION ONLY . For continuous infusion protocol, see prescribing information for lidocaine hydrochloride, USP for infusion solution.

Sterilization, Storage and Technical Procedures It is recommended that chemical disinfection be accomplished by wiping the vial thoroughly with cotton or gauze that has been moistened with either 91% isopropyl alcohol or 70% ethyl alcohol, just prior to use. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

⛔ Contraindications 47 words ▾

CONTRAINDICATIONS Lidocaine Hydrochloride Injection, USP is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. Lidocaine Hydrochloride Injection, USP should not be used in patients with STOKES-ADAMS syndrome, Wolff-Parkinson-White syndrome, or with severe degrees of sinoatrial, atrioventricular or intraventricular block.

⚠️ Warnings 208 words ▾

WARNINGS Constant monitoring of the electrocardiogram and blood pressure is essential in the proper administration of Lidocaine Hydrochloride Injection, USP intravenously. If hypotension or excessive depression of cardiac conductivity (such as prolongation of the PR interval and QRS complex and the appearance of aggravation of arrhythmias) is seen, administration of Lidocaine Hydrochloride Injection, USP should be discontinued. Emergency resuscitative equipment and drugs must be immediately available to manage possible adverse reactions involving the cardiovascular, respiratory, or central nervous system.

Occasional acceleration of ventricular rate may occur when Lidocaine Hydrochloride Injection, USP is administered to patients with atrial fibrillation. Toxicity may be manifest as central nervous system depression (sedation) or irritability (twitching), which may progress to frank convulsions accompanied by respiratory depression and/or arrest. Early recognition of premonitory signs, assurance of adequate oxygenation and (where necessary) establishment of artificial airway with ventilatory support are essential to management of the problem.

Should convulsions persist despite ventilatory support, small doses of anticonvulsant drugs may be used intravenously. Examples of such drugs include benzodiazepines (e.g., diazepam, lorazepam), or an ultrashort acting barbiturate (e.g., thiopental or thiamylal). If the patient is under anesthesia, a short-acting muscle relaxant (succinylcholine) may be used.

Longer acting drugs should be used only when recurrent convulsions are evidenced.

🤒 Adverse Reactions 136 words ▾

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. Most adverse reactions accompanying administration of Lidocaine Hydrochloride Injection, USP result from systemic toxicity affecting primarily the central nervous system and the cardiovascular system. Systemic reactions of the following types have been reported: 1.

Central Nervous System Light-headedness; drowsiness; dizziness; apprehension; euphoria; tinnitus; blurred vision or double vision; vomiting; sensations of heat; cold or numbness; twitching; tremors; convulsions; unconsciousness; respiratory depression and arrest. 2. Cardiovascular System Hypotension; cardiovascular collapse; and bradycardia which may lead to cardiac arrest.

Continuous monitoring of blood pressure and the electrocardiogram are essential to prevent these events. 3. Allergic reactions may occur but are infrequent.

There have been no reports of cross-sensitivity between lidocaine hydrochloride and procainamide or between lidocaine and quinidine.

🆘 Overdosage 136 words ▾

OVERDOSAGE Management of Adverse Reactions — 1. In the case of severe reaction, discontinue the use of Lidocaine Hydrochloride Injection, USP. 2.

Institute emergency resuscitative procedures and administer the emergency drugs necessary to manage the severe reaction. For severe convulsions, small increments of diazepam or an ultra short-acting barbiturate (thiopental or thiamylal); or if those are not available a short-acting barbiturate (pentobarbital or secobarbital); or if the patient is under anesthesia, a short-acting muscle relaxant (succinylcholine) may be given intravenously. Muscle relaxants and intravenous medications should only be used by those familiar with their use.

Patency of the airway and adequacy of ventilation must be assured. (See WARNINGS .) 3. Should circulatory depression occur, vasopressors, such as ephedrine, or meta raminol may be used.

Should cardiac arrest occur, immediate initiation of standard CPR procedures should commence.

🧬 Clinical Pharmacology 113 words ▾

CLINICAL PHARMACOLOGY Lidocaine hydrochloride exerts its antiarrhythmic effect by raising the electrical stimulation threshold of the ventricle during diastole. In usual therapeutic doses, lidocaine hydrochloride produces no change in myocardial contractility, systemic arterial pressure or in absolute refractory period. Onset of action is rapid after an intravenous bolus with a duration of action of approximately 15 to 20 minutes.

Approximately 90% of an administered dose of lidocaine hydrochloride is metabolized in the liver. The remainder (10%) of the drug is excreted unchanged in the urine. Pharmacokinetic data indicate reduced elimination of lidocaine after prolonged (24 hours) infusion with resultant prolongation of the half-life to approximately three times that seen following a single administration.

📦 How Supplied / Storage and Handling 54 words ▾

HOW SUPPLIED: For Direct Injection Only Lidocaine Hydrochloride Injection, USP Product Code Unit of Sale Strength Each 20805 NDC 63323-208-05 Unit of 25 2% 100 mg per 5 mL (20 mg per mL) NDC 63323-208-01 5 mL Single Dose Vial Preservative Free Discard Unused Portion. Use only if solution is clear and seal intact.

📋 Description 81 words ▾

DESCRIPTION Lidocaine hydrochloride, chemical name: acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride has the following structural formula: Lidocaine Hydrochloride Injection, USP intravenous for cardiac arrhythmias, is a sterile, nonpyrogenic solution prepared from lidocaine with the aid of hydrochloric acid in Water for Injection. Each mL contains: Lidocaine HCl 20 mg; Sodium Chloride 6 mg; Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (pH 5.0 to 7.0).

The container is for single use; solution contains no preservative. structure

⚠️ Precautions ~3 min read ▾

PRECAUTIONS The safe use of Lidocaine Hydrochloride Injection, USP requires careful ECG observation in an environment equipped and by persons trained for resuscitation. General Caution should be employed in the repeated use of Lidocaine Hydrochloride Injection, USP in patients with severe liver or renal disease because accumulation may occur and lead to toxic phenomena since Lidocaine Hydrochloride Injection, USP is metabolized mainly in the liver and excreted by the kidneys. This drug should also be used with caution in patients with hypovolemia and shock and all forms of heart block (see CONTRAINDICATIONS and WARNINGS ).

In patients with sinus bradycardia or incomplete heart block, the administration of Lidocaine Hydrochloride Injection, USP intravenously or the elimination of ventricular ectopic beats without prior acceleration in heart rate may promote more frequent and serious ventricular arrhythmias or complete heart block. (See CONTRAINDICATIONS .) Many potent anesthetic drugs, neuromuscular blocking agents and possibly amide local anesthetics may serve as triggering agents for the fulminant hypermetabolic process termed malignant hyperthermia.

Key to successful outcome of fulminant hypermetabolism is early recognition of premonitory signs, i.e., unexplained or unexpected tachycardia and increased metabolic rate as evidenced by respiratory and/or metabolic acidosis. Treatment includes administration of oxygen and discontinuation of lidocaine hydrochloride administration and where necessary administration of dantrolene sodium. For additional information on management, see prescribing information for dantrolene sodium.

Drug Interaction The effect of Lidocaine Hydrochloride Injection, USP for the management of cardiac arrhythmias is potentiated with the simultaneous or prior administration of propranolol. Lidocaine Hydrochloride Injection, USP should be used with caution in patients with digitalis toxicity accompanied by atrioventricular block. (See CONTRAINDICATIONS .) Drug interaction was studied with several beta-blockers (propranolol, metoprolol, nadolol, and pindolol).

Pretreatment with propranolol, metoprolol and nadolol increased the serum concentration of lidocaine. Pretreatment with pindolol did not affect the serum concentration of lidocaine. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies of Lidocaine Hydrochloride Injection, USP in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.

Pregnancy Category B Reproductive studies have been performed in the rat at doses up to 5 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Lidocaine Hydrochloride Injection, USP. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed.

Labor and Delivery The effects of Lidocaine Hydrochloride Injection, USP solution on the mother and the fetus, when used in the management of cardiac arrhythmias during labor and delivery, are not known. Lidocaine Hydrochloride Injection, USP readily crosses the placental barrier. Nursing Mothers It is not known whether this drug is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when Lidocaine Hydrochloride Injection, USP is administered to a nursing woman. Pediatric Use Safety and effectiveness in children have not been established by controlled clinical studies. (See DOSAGE AND ADMINISTRATION .)

General Caution should be employed in the repeated use of Lidocaine Hydrochloride Injection, USP in patients with severe liver or renal disease because accumulation may occur and lead to toxic phenomena since Lidocaine Hydrochloride Injection, USP is metabolized mainly in the liver and excreted by the kidneys. This drug should also be used with caution in patients with h… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 110 words ▾

PACKAGE LABEL - PRINCIPAL DISPLAY – Lidocaine HCl 5 mL Single Dose Vial Label NDC 63323-208-01 20805 LIDOCAINE HCl INJECTION, USP 2% 100 mg per 5 mL (20 mg per mL) Intravenous For Cardiac Arrhythmias Rx only 5 mL Single Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY – Lidocaine HCl 5mL Single Dose Vial Label

PACKAGE LABEL - PRINCIPAL DISPLAY – Lidocaine HCl 5 mL Vial Tray Label NDC 63323-208-05 20805 LIDOCAINE HCl INJECTION, USP 2% 100 mg per 5 mL (20 mg per mL) Intravenous For Cardiac Arrhythmias Rx only 25 Single Dose Vials, 5 mL PACKAGE LABEL - PRINCIPAL DISPLAY – Lidocaine HCl 5 mL Vial Tray Label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
17.6K
Units reimbursed last 4 qtrs
78.2K
Gross reimbursed last 4 qtrs
$1.46M
Avg / prescription
$83.12
Avg / unit
$18.6641
Latest quarter Q1 2026
3.6KRx
Fee-for-service vs managed care ⓘ
17% FFS 83% MCO
Fee-for-service · 3,028 Rx Managed care · 14,540 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: 120 units · 6.1 per 100k residents ID Montana: 1,207 units · 107 per 100k residents MT North Dakota: 555 units · 70.9 per 100k residents ND Minnesota: 77 units · 1.3 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 4,040 units · 20.6 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: 281 units · 8.8 per 100k residents IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 16,650 units · 141 per 100k residents OH Pennsylvania: 2,156 units · 16.6 per 100k residents PA New Jersey: 1,613 units · 17.4 per 100k residents NJ Massachusetts: 11,550 units · 165 per 100k residents MA California: 4,083 units · 10.5 per 100k residents CA Utah: 5 units · 0.1 per 100k residents UT Colorado: no data reported CO Nebraska: 75 units · 3.8 per 100k residents NE Missouri: 3,488 units · 56.3 per 100k residents MO Kentucky: 5,586 units · 123 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 754 units · 12.2 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 813 units · 38.5 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 5,315 units · 74.6 per 100k residents TN North Carolina: 5,463 units · 50.4 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 7,824 units · 193 per 100k residents OK Louisiana: 4,076 units · 89.1 per 100k residents LA Mississippi: 304 units · 10.3 per 100k residents MS Alabama: no data reported AL Georgia: 833 units · 7.6 per 100k residents GA D.C.: 230 units · 33.9 per 100k residents DC Hawaii: 23 units · 1.6 per 100k residents HI Texas: 85 units · 0.3 per 100k residents TX Florida: 1,039 units · 4.6 per 100k residents FL
Units reimbursed · per 100k residents
0.1193
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 Oklahoma 193 /100k
2 Massachusetts 165 /100k
3 Ohio 141 /100k
4 Kentucky 123 /100k
5 Montana 107 /100k
6 Louisiana 89.1 /100k
7 Tennessee 74.6 /100k
8 North Dakota 70.9 /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.

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.

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 ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Fresenius Kabi USA, LLC 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J2003 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
← 63323-0205-00 · Fresenius 63323-0221-38 · Fresenius →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.