NDC 0409-1746

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 Hospira, Inc.. The primary component is Bupivacaine Hydrochloride; Epinephrine Bitartrate.

Product ID0409-1746_03e2966a-eb08-4306-92a4-42bf638b4e45
NDC0409-1746
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 Date2005-09-12
Marketing CategoryNDA / NDA
Application NumberNDA016964
Labeler NameHospira, 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 0409-1746-10

10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1746-10) > 10 mL in 1 VIAL, SINGLE-DOSE (0409-1746-70)
Marketing Start Date2005-12-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-1746-10 [00409174610]

Marcaine with Epinephrine INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA016964
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-12-09

NDC 0409-1746-30 [00409174630]

Marcaine with Epinephrine INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA016964
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-09-12

NDC 0409-1746-70 [00409174670]

Marcaine with Epinephrine INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA016964
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-07-27

NDC 0409-1746-71 [00409174671]

Marcaine with Epinephrine INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA016964
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-07-27

Drug Details

Active Ingredients

IngredientStrength
BUPIVACAINE HYDROCHLORIDE2.5 mg/mL

OpenFDA Data

SPL SET ID:67578b56-7540-487e-1fba-481255620e78
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1725083
  • 1725082
  • 1724794
  • 1724796
  • 1867614
  • 1867596
  • 1672919
  • 1867594
  • 1867612
  • 1672917
  • 1725046
  • 1725044
  • 1012396
  • 1673242
  • 1673243
  • 1012404
  • 1012406
  • 1012400
  • 1012377
  • 1724786
  • 1724787
  • 1012388
  • 1012384
  • 1724884
  • 1012381
  • 1724880
  • 1725079
  • 1725078
  • 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 "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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.