0264-9598 NDC - LIDOCAINE HYDROCHLORIDE AND DEXTROSE (LIDOCAINE HYDROCHLORIDE ANHYDROUS AND DEXTROSE MONOHYDRATE)

Drug Information

Product NDC: 0264-9598

Proprietary Name: Lidocaine Hydrochloride and Dextrose

Non Proprietary Name: LIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATE

Active Ingredient(s):
  • 5 g/100mL DEXTROSE MONOHYDRATE;
  • .8 g/100mL LIDOCAINE HYDROCHLORIDE ANHYDROUS


Administration Route(s): INTRAVENOUS

Dosage Form(s): INJECTION, SOLUTION

Pharmacy Class(es):
  • Amide Local Anesthetic [EPC];
  • Amides [CS];
  • Antiarrhythmic [EPC];
  • Local Anesthesia [PE]

Labeler Information

Labeler Name: B. Braun Medical Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA019830
Marketing Category: NDA
Start Marketing Date:4/8/1992

Package Information

No. Package Code Package Description Billing Unit
10264-9598-2024 CONTAINER in 1 CASE (0264-9598-20) / 250 mL in 1 CONTAINERML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0264-9598The 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 NAMELidocaine Hydrochloride and DextroseThe 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 ANHYDROUS and DEXTROSE MONOHYDRATEThe 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 NAMEINTRAVENOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE4/8/1992This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct 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 NUMBERNDA019830This 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 NAMEB. Braun Medical Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEDEXTROSE MONOHYDRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUSAn 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 STRENGTH5; .8 
ACTIVE INGRED UNITg/100mL; g/100mL 
PHARM CLASSESAmide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] 

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