NDC 0409-1163

Bupivacaine Hydrochloride

Bupivacaine Hydrochloride

Bupivacaine Hydrochloride is a Perineural Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Bupivacaine Hydrochloride.

Product ID0409-1163_22d17a49-609f-4c2b-aaf0-f0ab712529ba
NDC0409-1163
Product TypeHuman Prescription Drug
Proprietary NameBupivacaine Hydrochloride
Generic NameBupivacaine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationPERINEURAL
Marketing Start Date2005-03-31
Marketing CategoryANDA / ANDA
Application NumberANDA070597
Labeler NameHospira, Inc.
Substance NameBUPIVACAINE HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesAmide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0409-1163-01

25 VIAL, MULTI-DOSE in 1 TRAY (0409-1163-01) > 50 mL in 1 VIAL, MULTI-DOSE (0409-1163-18)
Marketing Start Date2005-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-1163-18 [00409116318]

Bupivacaine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070597
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-08-05

NDC 0409-1163-01 [00409116301]

Bupivacaine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070597
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-03-31

Drug Details

Active Ingredients

IngredientStrength
BUPIVACAINE HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:02a845c3-4521-4926-e397-25ab536e7cf6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1867596
  • 1672919
  • 1867594
  • 1012404
  • 1672917
  • 1724880
  • 1012377
  • 1725082
  • 1724884
  • 1012396
  • 1724786
  • 1724787
  • 1012384
  • 1725078
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    71872-7133Bupivacaine HydrochlorideBupivacaine Hydrochloride
    36000-092Bupivacaine HydrochlorideBupivacaine Hydrochloride
    52584-163Bupivacaine HydrochlorideBupivacaine Hydrochloride
    52584-160Bupivacaine HydrochlorideBupivacaine Hydrochloride
    55150-250Bupivacaine HydrochlorideBupivacaine Hydrochloride
    55150-172Bupivacaine HydrochlorideBupivacaine Hydrochloride
    55150-249Bupivacaine HydrochlorideBupivacaine Hydrochloride
    55154-6970Bupivacaine HydrochlorideBupivacaine Hydrochloride
    55150-168Bupivacaine HydrochlorideBupivacaine Hydrochloride
    55150-169Bupivacaine HydrochlorideBupivacaine Hydrochloride
    55150-167Bupivacaine HydrochlorideBupivacaine Hydrochloride
    55150-170Bupivacaine HydrochlorideBupivacaine Hydrochloride
    55150-171Bupivacaine HydrochlorideBupivacaine Hydrochloride
    55154-4736Bupivacaine HydrochlorideBupivacaine Hydrochloride
    55154-6991Bupivacaine HydrochlorideBupivacaine Hydrochloride
    0409-1163Bupivacaine HydrochlorideBupivacaine Hydrochloride
    0409-1165Bupivacaine HydrochlorideBupivacaine Hydrochloride
    70518-2040Bupivacaine HydrochlorideBupivacaine Hydrochloride
    59923-720Bupivacaine HydrochlorideBupivacaine Hydrochloride
    59923-717Bupivacaine HydrochlorideBupivacaine Hydrochloride
    59923-718Bupivacaine HydrochlorideBupivacaine Hydrochloride
    59923-719Bupivacaine HydrochlorideBupivacaine Hydrochloride
    50090-4516Bupivacaine HydrochlorideBupivacaine Hydrochloride
    51662-1396BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE
    70518-2360Bupivacaine HydrochlorideBupivacaine Hydrochloride
    0404-9906MarcaineBupivacaine Hydrochloride
    0404-9907MarcaineBupivacaine Hydrochloride
    0404-9945SensorcaineBupivacaine Hydrochloride
    0404-9947SensorcaineBupivacaine Hydrochloride
    0404-9946Sensorcaine MPFbupivacaine hydrochloride

    © 2022 FDA.report
    This site is not affiliated with or endorsed by the FDA.