NDC 31382-557

Marcaine

Bupivacaine Hydrochloride And Epinephrine Bitartrate

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

Product ID31382-557_de328af3-2345-40cd-a393-ab91adc5c9a8
NDC31382-557
Product TypeHuman Prescription Drug
Proprietary NameMarcaine
Generic NameBupivacaine Hydrochloride And Epinephrine Bitartrate
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2013-06-01
Marketing CategoryANDA / ANDA
Application NumberANDA077250
Labeler NameCarestream Health Inc.
Substance NameBUPIVACAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE
Active Ingredient Strength5 mg/mL; mg/mL
Pharm ClassesAdrenergic 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]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 31382-557-05

50 CARTRIDGE in 1 CARTON (31382-557-05) > 1.8 mL in 1 CARTRIDGE
Marketing Start Date2013-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 31382-557-05 [31382055705]

Marcaine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA077250
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-06-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BUPIVACAINE HYDROCHLORIDE ANHYDROUS5 mg/mL

OpenFDA Data

SPL SET ID:63840275-9158-466c-8a2b-f9b06a236ab2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1673142
  • 1670365
  • Pharmacological Class

    • 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]

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

    NDCBrand NameGeneric Name
    0362-0557Marcainebupivacaine hydrochloride and epinephrine bitartrate
    0404-9906MarcaineBupivacaine Hydrochloride
    0404-9907MarcaineBupivacaine Hydrochloride
    0409-1559MarcaineBUPIVACAINE HYDROCHLORIDE
    0409-1560MarcaineBUPIVACAINE HYDROCHLORIDE
    0409-1582MarcaineBUPIVACAINE HYDROCHLORIDE
    0409-1587MarcaineBUPIVACAINE HYDROCHLORIDE
    0409-1610MarcaineBUPIVACAINE HYDROCHLORIDE
    31382-557MarcaineMarcaine
    52584-560MarcaineMarcaine
    52584-559MarcaineMarcaine
    0404-9908MARCAINE WITH EPINEPHRINEbupivacaine hydrochloride and epinephrine bitartrate
    0362-9011Vivacainebupivacaine hydrochloride and epinephrine bitartrate

    Trademark Results [Marcaine]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MARCAINE
    MARCAINE
    72330306 0894463 Live/Registered
    STERLING DRUG INC.
    1969-06-17

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