NDC 63323-461

SENSORCAINE

Bupivacaine Hydrochloride And Epinephrine Bitartrate

SENSORCAINE is a Infiltration; Perineural Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Bupivacaine Hydrochloride; Epinephrine Bitartrate.

Product ID63323-461_8dd36777-022a-21b9-e053-2a95a90a1fe6
NDC63323-461
Product TypeHuman Prescription Drug
Proprietary NameSENSORCAINE
Generic NameBupivacaine Hydrochloride And Epinephrine Bitartrate
Dosage FormInjection, Solution
Route of AdministrationINFILTRATION; PERINEURAL
Marketing Start Date2010-11-19
Marketing CategoryANDA / ANDA
Application NumberANDA070967
Labeler NameFresenius Kabi USA, LLC
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 63323-461-57

25 VIAL, MULTI-DOSE in 1 TRAY (63323-461-57) > 50 mL in 1 VIAL, MULTI-DOSE (63323-461-01)
Marketing Start Date2010-11-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-461-57 [63323046157]

SENSORCAINE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070967
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-11-19

NDC 63323-461-01 [63323046101]

SENSORCAINE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070967
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-16

NDC 63323-461-50 [63323046150]

SENSORCAINE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070967
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-19
Marketing End Date2011-07-14

Drug Details

Active Ingredients

IngredientStrength
BUPIVACAINE HYDROCHLORIDE2.5 mg/mL

OpenFDA Data

SPL SET ID:bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1867596
  • 1724810
  • 1867594
  • 1867620
  • 1012413
  • 1724809
  • 1012417
  • 1012377
  • 1867618
  • 1724786
  • 1724787
  • 1012384
  • UPC Code
  • 0363323468378
  • 0363323463571
  • 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 "SENSORCAINE" or generic name "Bupivacaine Hydrochloride And Epinephrine Bitartrate"

    NDCBrand NameGeneric Name
    0404-9945SensorcaineBupivacaine Hydrochloride
    0404-9947SensorcaineBupivacaine Hydrochloride
    52584-465SensorcaineBupivacaine Hydrochloride
    52584-467SensorcaineSensorcaine
    63323-463SENSORCAINESENSORCAINE
    63323-461SENSORCAINESENSORCAINE
    63323-465SENSORCAINESENSORCAINE
    63323-467SENSORCAINESENSORCAINE
    0362-0557Marcainebupivacaine hydrochloride and epinephrine bitartrate
    31382-557Marcainebupivacaine hydrochloride and epinephrine bitartrate
    0404-9908MARCAINE WITH EPINEPHRINEbupivacaine hydrochloride and epinephrine bitartrate
    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
    0362-9011Vivacainebupivacaine hydrochloride and epinephrine bitartrate

    Trademark Results [SENSORCAINE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SENSORCAINE
    SENSORCAINE
    73216968 1313013 Live/Registered
    Astra Pharmaceutical Products, Inc.
    1979-05-24

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