NDC 70529-006

Burapren 0.5%

Bupivacaine Hydrochloride

Burapren 0.5% is a Perineural Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by It3 Medical Llc. The primary component is Bupivacaine Hydrochloride.

Product ID70529-006_073dbdb7-03b4-4f34-84b0-c7477550a490
NDC70529-006
Product TypeHuman Prescription Drug
Proprietary NameBurapren 0.5%
Generic NameBupivacaine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationPERINEURAL
Marketing Start Date2017-03-01
Marketing CategoryANDA / ANDA
Application NumberANDA207183
Labeler NameIT3 Medical LLC
Substance NameBUPIVACAINE HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesAmide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70529-006-01

1 VIAL, MULTI-DOSE in 1 PACKAGE (70529-006-01) > 50 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2017-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70529-006-01 [70529000601]

Burapren 0.5% INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207183
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-01

Drug Details

Active Ingredients

IngredientStrength
BUPIVACAINE HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:464690ce-cc70-4bbb-8769-69b710908be1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1012404

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Burapren 0.5%" or generic name "Bupivacaine Hydrochloride"

    NDCBrand NameGeneric Name
    70529-006Burapren 0.5%Burapren 0.5%
    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
    0404-9946Sensorcaine MPFbupivacaine hydrochloride
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