NDC 52584-042

Bupivacaine Hydrochloride and Epinephrine

Bupivacaine Hydrochloride And Epinephrine

Bupivacaine Hydrochloride and Epinephrine is a Epidural; Infiltration; Intracaudal; 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; Epinephrine Bitartrate.

Product ID52584-042_799eebf4-53cc-404f-bd27-9857b2471cb3
NDC52584-042
Product TypeHuman Prescription Drug
Proprietary NameBupivacaine Hydrochloride and Epinephrine
Generic NameBupivacaine Hydrochloride And Epinephrine
Dosage FormInjection, Solution
Route of AdministrationEPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Marketing Start Date2010-07-01
Marketing CategoryANDA / ANDA
Application NumberANDA071165
Labeler NameGeneral Injectables & Vaccines, Inc
Substance NameBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active Ingredient Strength3 mg/mL; ug/mL
Pharm ClassesAmide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 52584-042-17

1 VIAL, SINGLE-DOSE in 1 BAG (52584-042-17) > 30 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2016-09-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-042-02 [52584004202]

Bupivacaine Hydrochloride and Epinephrine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA071165
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-07-01
Marketing End Date2017-01-16

NDC 52584-042-17 [52584004217]

Bupivacaine Hydrochloride and Epinephrine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA071165
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-22

Drug Details

Active Ingredients

IngredientStrength
BUPIVACAINE HYDROCHLORIDE2.5 mg/mL

OpenFDA Data

SPL SET ID:fab28f67-9dfa-4bf7-8758-c0c4b6aef56a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1012377
  • Pharmacological Class

    • Amide Local Anesthetic [EPC]
    • Amides [CS]
    • Local Anesthesia [PE]
    • Adrenergic alpha-Agonists [MoA]
    • Adrenergic beta-Agonists [MoA]
    • alpha-Adrenergic Agonist [EPC]
    • beta-Adrenergic Agonist [EPC]
    • Catecholamine [EPC]
    • Catecholamines [CS]
    • Amide Local Anesthetic [EPC]
    • Amides [CS]
    • Local Anesthesia [PE]
    • Adrenergic alpha-Agonists [MoA]
    • Adrenergic beta-Agonists [MoA]
    • alpha-Adrenergic Agonist [EPC]
    • beta-Adrenergic Agonist [EPC]
    • Catecholamine [EPC]
    • Catecholamines [CS]

    NDC Crossover Matching brand name "Bupivacaine Hydrochloride and Epinephrine" or generic name "Bupivacaine Hydrochloride And Epinephrine"

    NDCBrand NameGeneric Name
    0404-9828Bupivacaine Hydrochloride and EpinephrineBupivacaine Hydrochloride and Epinephrine
    0409-9042BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEbupivacaine hydrochloride and epinephrine
    0409-9043Bupivacaine Hydrochloride and EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
    0409-9045Bupivacaine Hydrochloride and EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
    0409-9046Bupivacaine Hydrochloride and EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
    52584-042Bupivacaine Hydrochloride and EpinephrineBupivacaine Hydrochloride and Epinephrine

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