NDC 0409-3613

Bupivacaine

Bupivacaine Hydrochloride

Bupivacaine is a Subarachnoid Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Bupivacaine Hydrochloride.

Product ID0409-3613_2dc10be4-040a-49ec-bfc8-9cac1c18428e
NDC0409-3613
Product TypeHuman Prescription Drug
Proprietary NameBupivacaine
Generic NameBupivacaine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationSUBARACHNOID
Marketing Start Date2005-01-31
Marketing CategoryANDA / ANDA
Application NumberANDA071810
Labeler NameHospira, Inc.
Substance NameBUPIVACAINE HYDROCHLORIDE
Active Ingredient Strength8 mg/mL
Pharm ClassesAmide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0409-3613-01

10 AMPULE in 1 CARTON (0409-3613-01) > 2 mL in 1 AMPULE (0409-3613-11)
Marketing Start Date2005-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-3613-52 [00409361352]

Bupivacaine Spinal INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA071810
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-04-26
Marketing End Date2011-07-27

NDC 0409-3613-01 [00409361301]

Bupivacaine Spinal INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA071810
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-01-31

NDC 0409-3613-11 [00409361311]

Bupivacaine Spinal INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA071810
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-12-17

Drug Details

Active Ingredients

IngredientStrength
BUPIVACAINE HYDROCHLORIDE7.5 mg/mL

OpenFDA Data

SPL SET ID:7a8d2539-4422-4312-0298-207ef1a2948e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1724784

    • Pharmacological Class

    • Amide Local Anesthetic [EPC]
    • Amides [CS]
    • Local Anesthesia [PE]

    NDC Crossover Matching brand name "Bupivacaine" or generic name "Bupivacaine Hydrochloride"

    NDCBrand NameGeneric Name
    0409-3613BupivacaineBupivacaine
    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
    0404-9906MarcaineBupivacaine Hydrochloride
    0404-9907MarcaineBupivacaine Hydrochloride
    0404-9945SensorcaineBupivacaine Hydrochloride
    0404-9947SensorcaineBupivacaine Hydrochloride
    0404-9946Sensorcaine MPFbupivacaine hydrochloride
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.