NDC 0409-1159

BUPIVACAINE HYDROCHLORIDE

Bupivacaine Hydrochloride

BUPIVACAINE HYDROCHLORIDE 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.

Product ID0409-1159_19afa13b-9fad-42af-92f2-fed038e8ba88
NDC0409-1159
Product TypeHuman Prescription Drug
Proprietary NameBUPIVACAINE HYDROCHLORIDE
Generic NameBupivacaine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationEPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Marketing Start Date2015-08-11
Marketing CategoryANDA / ANDA
Application NumberANDA070583
Labeler NameHospira, 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 0409-1159-10

25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1159-10) > 30 mL in 1 VIAL, SINGLE-DOSE (0409-1159-09)
Marketing Start Date2015-08-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-1159-09 [00409115909]

BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070583
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-08-11

NDC 0409-1159-01 [00409115901]

BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070583
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-05-06

NDC 0409-1159-10 [00409115910]

BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070583
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-08-11

NDC 0409-1159-02 [00409115902]

BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070583
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-08-15

NDC 0409-1159-18 [00409115918]

BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070583
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-08-05

NDC 0409-1159-19 [00409115919]

BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070583
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-08-05

Drug Details

Active Ingredients

IngredientStrength
BUPIVACAINE HYDROCHLORIDE2.5 mg/mL

OpenFDA Data

SPL SET ID:bb44c7e1-d911-4788-908f-09b7b271969b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1725082
  • 1724884
  • 1867596
  • 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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