NDC 63323-465

SENSORCAINE

Bupivacaine Hydrochloride

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.

Product ID63323-465_8ac30e97-72da-33be-e053-2995a90ac613
NDC63323-465
Product TypeHuman Prescription Drug
Proprietary NameSENSORCAINE
Generic NameBupivacaine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINFILTRATION; PERINEURAL
Marketing Start Date2010-11-19
Marketing CategoryNDA / NDA
Application NumberNDA018304
Labeler NameFresenius Kabi USA, LLC
Substance NameBUPIVACAINE HYDROCHLORIDE
Active Ingredient Strength3 mg/mL
Pharm ClassesAmide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63323-465-57

25 VIAL, MULTI-DOSE in 1 TRAY (63323-465-57) > 50 mL in 1 VIAL, MULTI-DOSE (63323-465-01)
Marketing Start Date2010-11-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-465-50 [63323046550]

SENSORCAINE INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA018304
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-19
Marketing End Date2011-07-14

NDC 63323-465-57 [63323046557]

SENSORCAINE INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA018304
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-11-19

NDC 63323-465-01 [63323046501]

SENSORCAINE INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA018304
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-12

Drug Details

Active Ingredients

IngredientStrength
BUPIVACAINE HYDROCHLORIDE2.5 mg/mL

OpenFDA Data

SPL SET ID:eb6d8fee-def4-4c96-9972-695e8cea8ea8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1012457
  • 1012421
  • 1012455
  • 1673296
  • 1012404
  • 1672917
  • 1672919
  • 1673298
  • 1725082
  • 1725177
  • 1724885
  • 1724884
  • 1012396
  • 1012391
    • UPC Code
  • 0363323466374
  • 0363323464370

    • Pharmacological Class

    • Amide Local Anesthetic [EPC]
    • Amides [CS]
    • Local Anesthesia [PE]

    NDC Crossover Matching brand name "SENSORCAINE" or generic name "Bupivacaine Hydrochloride"

    NDCBrand NameGeneric Name
    0404-9945SensorcaineBupivacaine Hydrochloride
    0404-9947SensorcaineBupivacaine Hydrochloride
    52584-465SensorcaineSensorcaine
    52584-467SensorcaineSensorcaine
    63323-463SENSORCAINESENSORCAINE
    63323-461SENSORCAINESENSORCAINE
    63323-465SENSORCAINESENSORCAINE
    63323-467SENSORCAINESENSORCAINE
    0143-9328Bupivacaine HydrochlorideBupivacaine Hydrochloride
    0143-9329Bupivacaine HydrochlorideBupivacaine Hydrochloride
    0143-9330Bupivacaine HydrochlorideBupivacaine Hydrochloride
    0143-9331Bupivacaine HydrochlorideBupivacaine Hydrochloride
    0143-9332Bupivacaine HydrochlorideBupivacaine Hydrochloride
    0143-9333Bupivacaine HydrochlorideBupivacaine Hydrochloride
    0143-9334Bupivacaine HydrochlorideBupivacaine Hydrochloride
    0143-9335Bupivacaine HydrochlorideBupivacaine Hydrochloride
    0404-9826Bupivacaine HydrochlorideBupivacaine Hydrochloride
    0404-9827Bupivacaine HydrochlorideBupivacaine Hydrochloride
    0409-1159BUPIVACAINE HYDROCHLORIDEbupivacaine hydrochloride
    0409-1160Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDE
    0409-1162BUPIVACAINE HYDROCHLORIDEbupivacaine hydrochloride
    0404-9906MarcaineBupivacaine Hydrochloride
    0404-9907MarcaineBupivacaine Hydrochloride
    0404-9946Sensorcaine MPFbupivacaine hydrochloride

    Trademark Results [SENSORCAINE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SENSORCAINE
    SENSORCAINE
    73216968 1313013 Live/Registered
    Astra Pharmaceutical Products, Inc.
    1979-05-24
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.