NDC 52584-160

Bupivacaine Hydrochloride

Bupivacaine Hydrochloride

Bupivacaine Hydrochloride is a Infiltration; Perineural Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc. The primary component is Bupivacaine Hydrochloride.

Product ID52584-160_1bfab1ec-6a15-4893-bdc8-a4d95495ccbd
NDC52584-160
Product TypeHuman Prescription Drug
Proprietary NameBupivacaine Hydrochloride
Generic NameBupivacaine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINFILTRATION; PERINEURAL
Marketing Start Date2010-07-01
Marketing CategoryANDA / ANDA
Application NumberANDA070590
Labeler NameGeneral Injectables & Vaccines, Inc
Substance NameBUPIVACAINE HYDROCHLORIDE
Active Ingredient Strength3 mg/mL
Pharm ClassesAmide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 52584-160-01

1 VIAL, MULTI-DOSE in 1 BAG (52584-160-01) > 50 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2016-09-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-160-01 [52584016001]

Bupivacaine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070590
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-09

Drug Details

Active Ingredients

IngredientStrength
BUPIVACAINE HYDROCHLORIDE2.5 mg/mL

OpenFDA Data

SPL SET ID:6e7fe2ee-5ee5-40a0-8644-9999032ac716
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1012396

    • 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
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