0362-9011 NDC - VIVACAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)

Drug Information

Product NDC: 0362-9011

Proprietary Name: Vivacaine

Non Proprietary Name: bupivacaine hydrochloride and epinephrine bitartrate

Active Ingredient(s):
  • 5 mg/mL BUPIVACAINE HYDROCHLORIDE ANHYDROUS;
  • .005 mg/mL EPINEPHRINE BITARTRATE


Administration Route(s): SUBCUTANEOUS

Dosage Form(s): INJECTION, SOLUTION

Pharmacy Class(es):
  • Amide Local Anesthetic [EPC];
  • Amides [CS];
  • Local Anesthesia [PE];
  • Adrenergic alpha-Agonists [MoA];
  • Adrenergic beta-Agonists [MoA];
  • alpha-Adrenergic Agonist [EPC];
  • beta-Adrenergic Agonist [EPC];
  • Catecholamine [EPC];
  • Catecholamines [CS]

Labeler Information

Labeler Name: Septodont, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA077250
Marketing Category: ANDA
Start Marketing Date:6/1/2013

Package Information

No. Package Code Package Description Billing Unit
10362-9011-1010 CARTRIDGE in 1 CARTON (0362-9011-10) > 1.7 mL in 1 CARTRIDGE
20362-9011-5050 CARTRIDGE in 1 CARTON (0362-9011-50) > 1.8 mL in 1 CARTRIDGEML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0362-9011The 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 NAMEVivacaineThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEbupivacaine hydrochloride and epinephrine bitartrateThe 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 NAMESUBCUTANEOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE12/17/2009This 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 NUMBERANDA077250This 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 NAMESeptodont Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH5; .0091 
ACTIVE INGRED UNITmg/mL; mg/mL 
PHARM CLASSESAmide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS] 
PRODUCT NDC0362-9011The 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 NAMEVivacaineThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEbupivacaine hydrochloride and epinephrine bitartrateThe 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 NAMESUBCUTANEOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE6/1/2013This 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 NUMBERANDA077250This 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 NAMESeptodont, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEBUPIVACAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH5; .005 
ACTIVE INGRED UNITmg/mL; mg/mL 
PHARM CLASSESAmide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS] 

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This page was last updated on: 5/17/2019