NDC 0409-9045

Bupivacaine Hydrochloride and Epinephrine

Bupivacaine Hydrochloride And Epinephrine

Bupivacaine Hydrochloride and Epinephrine is a Epidural; 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 ID0409-9045_22d17a49-609f-4c2b-aaf0-f0ab712529ba
NDC0409-9045
Product TypeHuman Prescription Drug
Proprietary NameBupivacaine Hydrochloride and Epinephrine
Generic NameBupivacaine Hydrochloride And Epinephrine
Dosage FormInjection, Solution
Route of AdministrationEPIDURAL; INTRACAUDAL; PERINEURAL
Marketing Start Date2005-05-18
Marketing CategoryANDA / ANDA
Application NumberANDA071168
Labeler NameHospira, Inc.
Substance NameBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active Ingredient Strength5 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 0409-9045-01

10 VIAL, SINGLE-DOSE in 1 CARTON (0409-9045-01) > 10 mL in 1 VIAL, SINGLE-DOSE (0409-9045-11)
Marketing Start Date2005-09-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-9045-11 [00409904511]

Bupivacaine Hydrochloride and Epinephrine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA071168
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-08-05

NDC 0409-9045-02 [00409904502]

Bupivacaine Hydrochloride and Epinephrine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA071168
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-05-18
Marketing End Date2012-05-01

NDC 0409-9045-16 [00409904516]

Bupivacaine Hydrochloride and Epinephrine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA071168
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-08-05

NDC 0409-9045-17 [00409904517]

Bupivacaine Hydrochloride and Epinephrine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA071168
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-03-21

NDC 0409-9045-12 [00409904512]

Bupivacaine Hydrochloride and Epinephrine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA071168
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-08-05
Marketing End Date2016-10-18

NDC 0409-9045-01 [00409904501]

Bupivacaine Hydrochloride and Epinephrine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA071168
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-09-08

Drug Details

Active Ingredients

IngredientStrength
BUPIVACAINE HYDROCHLORIDE5 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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