NDC 70529-005

Durapren 0.5%

Bupivacaine Hydrochloride

Durapren 0.5% is a Epidural; Intracaudal; 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 ID70529-005_6e345233-c80e-4bf9-9609-f3687ba29330
NDC70529-005
Product TypeHuman Prescription Drug
Proprietary NameDurapren 0.5%
Generic NameBupivacaine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationEPIDURAL; INTRACAUDAL; PERINEURAL
Marketing Start Date2017-03-01
Marketing CategoryNDA / NDA
Application NumberNDA016964
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 Through2021-12-31

Packaging

NDC 70529-005-01

1 VIAL, SINGLE-DOSE in 1 PACKAGE (70529-005-01) > 30 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2017-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70529-005-01 [70529000501]

Durapren 0.5% INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA016964
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-01

Drug Details

Active Ingredients

IngredientStrength
BUPIVACAINE HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:ed820739-b9f4-454b-b8b7-a9df81f24c4e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1724884

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    70529-005Durapren 0.5%Durapren 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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