NDC 63323-472

SENSORCAINE MPF

Bupivacaine Hydrochloride

SENSORCAINE MPF is a Epidural; Retrobulbar 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 ID63323-472_8dd36777-022a-21b9-e053-2a95a90a1fe6
NDC63323-472
Product TypeHuman Prescription Drug
Proprietary NameSENSORCAINE MPF
Generic NameBupivacaine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationEPIDURAL; RETROBULBAR
Marketing Start Date2010-11-19
Marketing CategoryANDA / ANDA
Application NumberANDA070554
Labeler NameFresenius Kabi USA, LLC
Substance NameBUPIVACAINE HYDROCHLORIDE
Active Ingredient Strength8 mg/mL
Pharm ClassesAmide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63323-472-17

25 VIAL, SINGLE-DOSE in 1 TRAY (63323-472-17) > 10 mL in 1 VIAL, SINGLE-DOSE (63323-472-03)
Marketing Start Date2010-11-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-472-03 [63323047203]

SENSORCAINE MPF INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070554
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-16

NDC 63323-472-01 [63323047201]

SENSORCAINE MPF INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070554
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-16

NDC 63323-472-10 [63323047210]

SENSORCAINE MPF INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070554
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-19
Marketing End Date2011-07-14

NDC 63323-472-33 [63323047233]

SENSORCAINE MPF INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA018304
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-11-19
Marketing End Date2014-07-18

NDC 63323-472-37 [63323047237]

SENSORCAINE MPF INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070554
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-11-19

NDC 63323-472-30 [63323047230]

SENSORCAINE MPF INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070554
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-19
Marketing End Date2011-07-14

NDC 63323-472-17 [63323047217]

SENSORCAINE MPF INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070554
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-11-19

Drug Details

Active Ingredients

IngredientStrength
BUPIVACAINE HYDROCHLORIDE7.5 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]

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

    NDCBrand NameGeneric Name
    0404-9946Sensorcaine MPFbupivacaine hydrochloride
    70518-1392SENSORCAINE MPFSENSORCAINE MPF
    52584-466Sensorcaine MPFSensorcaine MPF
    63323-464Sensorcaine MPFSensorcaine MPF
    63323-472SENSORCAINE MPFSENSORCAINE MPF
    63323-466Sensorcaine MPFSensorcaine MPF
    63323-460SENSORCAINE MPFSENSORCAINE MPF
    63323-462SENSORCAINE MPFSENSORCAINE MPF
    63323-468SENSORCAINE MPFSENSORCAINE MPF
    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
    0404-9945SensorcaineBupivacaine Hydrochloride
    0404-9947SensorcaineBupivacaine 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.