NDC 0362-9011

Vivacaine

Bupivacaine Hydrochloride And Epinephrine Bitartrate

Vivacaine is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Septodont, Inc.. The primary component is Bupivacaine Hydrochloride Anhydrous; Epinephrine Bitartrate.

• Product ID: 0362-9011_20e1829c-909e-4dfb-82a6-f39d44b227e1
• NDC: 0362-9011
• Product Type: Human Prescription Drug
• Proprietary Name: Vivacaine
• Generic Name: Bupivacaine Hydrochloride And Epinephrine Bitartrate
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2013-06-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077250
• Labeler Name: Septodont, Inc.
• Substance Name: BUPIVACAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE
• Active Ingredient Strength: 5 mg/mL; mg/mL
• Pharm Classes: 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]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0362-9011-50

50 CARTRIDGE in 1 CARTON (0362-9011-50) > 1.8 mL in 1 CARTRIDGE

• Marketing Start Date: 2013-06-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0362-9011-10 [00362901110]

Vivacaine INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA077250
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-12-17
• Inactivation Date: 2019-10-21

NDC 0362-9011-50 [00362901150]

Vivacaine INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA077250
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-06-01

Drug Details

Active Ingredients

Ingredient	Strength
BUPIVACAINE HYDROCHLORIDE	5 mg/mL

OpenFDA Data

• SPL SET ID: 7257e8e4-9007-408c-9a9b-109bdd1d6d1e
• Manufacturer:
  • Septodont Inc.
• UNII:
  • 7TQO7W3VT8
  • 30Q7KI53AK
• RxNorm Concept Unique ID - RxCUI:
  • 1012461
  • 1670365

Pharmacological Class

• 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]

NDC Crossover Matching brand name "Vivacaine" or generic name "Bupivacaine Hydrochloride And Epinephrine Bitartrate"

NDC	Brand Name	Generic Name
0362-9011	Vivacaine	bupivacaine hydrochloride and epinephrine bitartrate
0362-0557	Marcaine	bupivacaine hydrochloride and epinephrine bitartrate
31382-557	Marcaine	bupivacaine hydrochloride and epinephrine bitartrate
0404-9908	MARCAINE WITH EPINEPHRINE	bupivacaine hydrochloride and epinephrine bitartrate
0409-1746	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
0409-1749	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
0409-1752	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
0409-1755	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
52584-746	MARCAINE WITH EPINEPHRINE	bupivacaine hydrochloride and epinephrine bitartrate
63323-460	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE
63323-461	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE