NDC 0409-9042

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 Hospira, Inc.. The primary component is Bupivacaine Hydrochloride; Epinephrine Bitartrate.

Product ID0409-9042_1f9e078e-8707-4fdb-bafd-644f8115e6a4
NDC0409-9042
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 Date2015-10-07
Marketing CategoryANDA / ANDA
Application NumberANDA071165
Labeler NameHospira, 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 Through2020-12-31

Packaging

NDC 0409-9042-01

10 VIAL, SINGLE-DOSE in 1 CARTON (0409-9042-01) > 10 mL in 1 VIAL, SINGLE-DOSE (0409-9042-11)
Marketing Start Date2005-08-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-9042-01 [00409904201]

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA071165
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-08-26

NDC 0409-9042-09 [00409904209]

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA071165
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-10-07

NDC 0409-9042-16 [00409904216]

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA071165
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-08-05

NDC 0409-9042-10 [00409904210]

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA071165
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-10-07

NDC 0409-9042-12 [00409904212]

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA071165
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-08-05
Marketing End Date2016-10-18

NDC 0409-9042-17 [00409904217]

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA071165
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-03-21

NDC 0409-9042-11 [00409904211]

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA071165
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-08-05

NDC 0409-9042-02 [00409904202]

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA071165
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-06-15
Marketing End Date2012-05-01

Drug Details

Active Ingredients

IngredientStrength
BUPIVACAINE HYDROCHLORIDE2.5 mg/mL

OpenFDA Data

SPL SET ID:02a845c3-4521-4926-e397-25ab536e7cf6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1867596
  • 1672919
  • 1867594
  • 1012404
  • 1672917
  • 1724880
  • 1012377
  • 1725082
  • 1724884
  • 1012396
  • 1724786
  • 1724787
  • 1012384
  • 1725078
  • 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]

    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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