NDC 0362-0557

Marcaine

Bupivacaine Hydrochloride And Epinephrine Bitartrate

Marcaine 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: 0362-0557_04f1dd5c-3648-437b-bafd-2bf6412efbf9
• NDC: 0362-0557
• Product Type: Human Prescription Drug
• Proprietary Name: Marcaine
• Generic Name: Bupivacaine Hydrochloride And Epinephrine Bitartrate
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2018-06-12
• 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: 2020-12-31

Packaging

NDC 0362-0557-05

50 CARTRIDGE in 1 CARTON (0362-0557-05) > 1.8 mL in 1 CARTRIDGE

• Marketing Start Date: 2018-06-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0362-0557-05 [00362055705]

Marcaine INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA077250
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-06-12

Drug Details

Active Ingredients

Ingredient	Strength
BUPIVACAINE HYDROCHLORIDE ANHYDROUS	5 mg/mL

OpenFDA Data

• SPL SET ID: 3e196aa4-0b01-44db-9267-98a995b54743
• Manufacturer:
  • Septodont, Inc.
• UNII:
  • 30Q7KI53AK
  • AKA908P8J1
• RxNorm Concept Unique ID - RxCUI:
  • 1673142
  • 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]
• 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 "Marcaine" or generic name "Bupivacaine Hydrochloride And Epinephrine Bitartrate"

NDC	Brand Name	Generic Name
0362-0557	Marcaine	bupivacaine hydrochloride and epinephrine bitartrate
0404-9906	Marcaine	Bupivacaine Hydrochloride
0404-9907	Marcaine	Bupivacaine Hydrochloride
0409-1559	Marcaine	BUPIVACAINE HYDROCHLORIDE
0409-1560	Marcaine	BUPIVACAINE HYDROCHLORIDE
0409-1582	Marcaine	BUPIVACAINE HYDROCHLORIDE
0409-1587	Marcaine	BUPIVACAINE HYDROCHLORIDE
0409-1610	Marcaine	BUPIVACAINE HYDROCHLORIDE
31382-557	Marcaine	Marcaine
52584-560	Marcaine	Marcaine
52584-559	Marcaine	Marcaine
0404-9908	MARCAINE WITH EPINEPHRINE	bupivacaine hydrochloride and epinephrine bitartrate
0362-9011	Vivacaine	bupivacaine hydrochloride and epinephrine bitartrate