Lidocaine

Product NDC
0362-0262
11-digit product format
003620262
Labeler code
0362
Product ID
0362-0262_70fc8bb8-829f-4021-b450-9a65c3ddd3ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride and Epinephrine
Dosage form
INJECTION, SOLUTION
Route
SUBMUCOSAL
Labeler
Septodont, Inc.
Application
ANDA088389
Marketing category
ANDA
Marketing start
2018-08-10
Substance
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE
Active strength
.02; 20 mg/mL; mg/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A088389-001LIGNOSPAN FORTEEPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINESeptodont, Inc.df130310-41db-45df-a214-9da01cf0bf412024-02-05Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS DENTAL PRACTITIONERS WHO EMPLOY LOCAL ANESTHETIC AGENTS SHOULD BE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF EMERGENCIES WHICH MAY ARISE FROM THEIR USE. RESUSCITATIVE EQUIPMENT, OXYGEN AND OTHER RESUSCITATIVE DRUGS SHOULD BE AVAILABLE FOR IMMEDIATE USE. To minimize the likelihood of intravascular injection, aspiration should be performed before the local anesthetic solution is injected. If blood is aspirated, 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 assure that intravascular injection will be avoided. Local anesthetic procedures should be used with caution when there is inflammation and/or sepsis in the region of the proposed injection. Lidocaine hydrochloride and epinephrine injection, USP solutions contain potassium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non asthmatic people. The American Heart Association has made the following recommendation regarding the use of local anesthetics with vasoconstrictors in patients with ischemic heart disease: “Vasoconstrictor agents should be used in local anesthesia solutions during dental practice only when it is clear that the procedure will be shortened or the analgesia rendered more profound. When a vasoconstrictor is indicated, extreme care should be taken to avoid intravascular injection. The minimum possible amount of vasoconstrictor should be used.” (Kaplan, EL. editor: Cardiovascular disease in dental practice, Dallas 1986, American Heart Association). Methemoglobinemia: Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring f...

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

ADVERSE REACTIONS Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide-type local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels (which may be caused by excessive dosage, rapid absorption unintended intravascular injection or slow metabolic degradation), injection technique, volume of injection, 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 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 in response to lidocaine are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest. In addition, the beta-adrenergic receptor- stimulating action of epinephrine may lead to excitatory cardiovascular responses, such as tachycardia, palpitations, and hypertension. Signs and symptoms of depressed cardiovascular function may commonly result from a vasovagal reaction, particularly if the patient is in an upright position. Less commonly, they may result from a direct effect of the drug. Failure to recognize the premonitory signs such as sweating, a feeling of faintness, changes in pulse or sensorium may result in progressive cerebral hypoxia and seizure or serious cardiovascular catastrophe. Management consists of placing the patient in the recumbent position and ventilation with oxygen. Supportive treatment of circulatory depression may require the administration of intravenous fluids and, when appropriate, a va...

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE.02 mg/mL
EPINEPHRINE BITARTRATE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A, 30Q7KI53AK
Rxcui1657026

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
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1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0362-0262-05Lidocaine50 in 1 CARTONINJECTION, SOLUTION504
0362-0262-05Lidocaine1.7 mL in 1 CARTRIDGEINJECTION, SOLUTION1.74

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0362-0262-05ML - Milliliter0362-02623e617a00-1753-4911-8caa-527909f3519c12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0362-0262LIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE) INJECTION, SOLUTION [SEPTODONT, INC.]4Current NDC, Legacy NDC, 2 package rows20240206_df130310-41db-45df-a214-9da01cf0bf41.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1657026lidocaine HCl 2 % with EPINEPHrine 1:50,000 in 1.7 ML Dental CartridgePSNdf130310-41db-45df-a214-9da01cf0bf414
16570261.7 ML epinephrine 0.02 MG/ML / lidocaine hydrochloride 20 MG/ML CartridgeSCDdf130310-41db-45df-a214-9da01cf0bf414
1657026epinephrine 1:50,000 / lidocaine HCl 2 % 1.7 ML CartridgeSYdf130310-41db-45df-a214-9da01cf0bf414
1657026lidocaine HCl 2 % with epinephrine 1:50,000 1.7 ML Dental CartridgeSYdf130310-41db-45df-a214-9da01cf0bf414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0362-0262-050036202620550 CARTRIDGE in 1 CARTON (0362-0262-05) / 1.7 mL in 1 CARTRIDGE50 cartridge2018-08-100000-00-00NoNoCurrent