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.
PROPRIETARY NAMEVivacaineThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE12/17/2009This is the date that the labeler indicates was the start of its marketing of the drug product.
LABELER NAMESeptodont Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
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.
PROPRIETARY NAMEVivacaineThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE6/1/2013This is the date that the labeler indicates was the start of its marketing of the drug product.
LABELER NAMESeptodont, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 5/20/2020