NDC 52584-746

MARCAINE WITH EPINEPHRINE

Bupivacaine Hydrochloride And Epinephrine Bitartrate

MARCAINE WITH EPINEPHRINE is a Epidural; Infiltration; Intracaudal; Perineural Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc.. The primary component is Bupivacaine Hydrochloride; Epinephrine Bitartrate.

Product ID52584-746_4ba01ae9-9296-4ab5-a60e-0e5c516c73e2
NDC52584-746
Product TypeHuman Prescription Drug
Proprietary NameMARCAINE WITH EPINEPHRINE
Generic NameBupivacaine Hydrochloride And Epinephrine Bitartrate
Dosage FormInjection, Solution
Route of AdministrationEPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Marketing Start Date2019-11-04
Marketing CategoryNDA / NDA
Application NumberNDA016964
Labeler NameGeneral Injectables & Vaccines, Inc.
Substance NameBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active Ingredient Strength3 mg/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]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52584-746-71

1 VIAL, SINGLE-DOSE in 1 BAG (52584-746-71) > 30 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2019-11-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-746-71 [52584074671]

MARCAINE WITH EPINEPHRINE INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA016964
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-04

Drug Details

Active Ingredients

IngredientStrength
BUPIVACAINE HYDROCHLORIDE2.5 mg/mL

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 WITH EPINEPHRINE" or generic name "Bupivacaine Hydrochloride And Epinephrine Bitartrate"

NDCBrand NameGeneric Name
0404-9908MARCAINE WITH EPINEPHRINEbupivacaine hydrochloride and epinephrine bitartrate
0409-1541Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
0409-1746Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
0409-1749Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
0409-1752Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
0409-1755Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
0409-3812Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
0409-4208Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
0409-5738Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
0409-6581Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
52584-746MARCAINE WITH EPINEPHRINEMARCAINE WITH EPINEPHRINE
0362-0557Marcainebupivacaine hydrochloride and epinephrine bitartrate
0362-9011Vivacainebupivacaine hydrochloride and epinephrine bitartrate

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