70529-100 NDC - LIXTRAXEN 1% (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE)

Drug Information

Product NDC: 70529-100

Proprietary Name: Lixtraxen 1%

Non Proprietary Name: Lidocaine Hydrochloride and Epinephrine

Active Ingredient(s):
  • 10 ug/mL EPINEPHRINE;
  • 10 mg/mL LIDOCAINE HYDROCHLORIDE


Administration Route(s): INFILTRATION; PERINEURAL

Dosage Form(s): INJECTION, SOLUTION

Pharmacy Class(es):
  • 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]

Labeler Information

Labeler Name: IT3 Medical LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA089644
Marketing Category: ANDA
Start Marketing Date:1/1/2019

Package Information

No. Package Code Package Description Billing Unit
170529-100-011 VIAL, MULTI-DOSE in 1 PACKAGE (70529-100-01) / 20 mL in 1 VIAL, MULTI-DOSE
270529-100-032 VIAL, MULTI-DOSE in 1 PACKAGE (70529-100-03) / 20 mL in 1 VIAL, MULTI-DOSE
370529-100-053 VIAL, MULTI-DOSE in 1 PACKAGE (70529-100-05) / 20 mL in 1 VIAL, MULTI-DOSE
470529-100-111 VIAL, MULTI-DOSE in 1 PACKAGE (70529-100-11) / 30 mL in 1 VIAL, MULTI-DOSE
570529-100-132 VIAL, MULTI-DOSE in 1 PACKAGE (70529-100-13) / 30 mL in 1 VIAL, MULTI-DOSE
670529-100-153 VIAL, MULTI-DOSE in 1 PACKAGE (70529-100-15) / 30 mL in 1 VIAL, MULTI-DOSE

NDC Record

Field Name Field Value Definition
PRODUCT NDC70529-100The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMELixtraxen 1%The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMELidocaine Hydrochloride and EpinephrineThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINFILTRATION; PERINEURALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE1/1/2019This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA089644This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEIT3 Medical LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEEPINEPHRINE; LIDOCAINE HYDROCHLORIDEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH10; 10 
ACTIVE INGRED UNITug/mL; mg/mL 
PHARM CLASSESAdrenergic 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] 

Download Record

Download this NDC record in Text format: Export

Download this NDC record in Excel (CSV) format: Export

Download this NDC record in XML format: Export

This page was last updated on: 2/1/2023