NDC 70529-008

Burapren 0.75%

Bupivacaine Hydrochloride

Burapren 0.75% is a Epidural; Retrobulbar Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by It3 Medical Llc. The primary component is Bupivacaine Hydrochloride.

Product ID70529-008_02e9115c-06fc-4afc-ba57-da8b891e0e76
NDC70529-008
Product TypeHuman Prescription Drug
Proprietary NameBurapren 0.75%
Generic NameBupivacaine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationEPIDURAL; RETROBULBAR
Marketing Start Date2017-03-01
Marketing CategoryANDA / ANDA
Application NumberANDA203895
Labeler NameIT3 Medical LLC
Substance NameBUPIVACAINE HYDROCHLORIDE
Active Ingredient Strength8 mg/mL
Pharm ClassesAmide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 70529-008-01

1 VIAL, SINGLE-DOSE in 1 PACKAGE (70529-008-01) > 30 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2017-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70529-008-01 [70529000801]

Burapren 0.75% INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA203895
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-01

Drug Details

Active Ingredients

IngredientStrength
BUPIVACAINE HYDROCHLORIDE7.5 mg/mL

OpenFDA Data

SPL SET ID:85667365-c166-4fd4-a8dc-d0d3340179fc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1724786

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Burapren 0.75%" or generic name "Bupivacaine Hydrochloride"

    NDCBrand NameGeneric Name
    70529-008Burapren 0.75%Burapren 0.75%
    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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