NDC 36000-092

Bupivacaine Hydrochloride

Bupivacaine Hydrochloride

Bupivacaine Hydrochloride is a Intraspinal Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is Bupivacaine Hydrochloride.

Product ID36000-092_0acf1ee2-471f-4dfb-90dc-8590c773c611
NDC36000-092
Product TypeHuman Prescription Drug
Proprietary NameBupivacaine Hydrochloride
Generic NameBupivacaine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRASPINAL
Marketing Start Date2016-08-08
Marketing CategoryANDA / ANDA
Application NumberANDA207266
Labeler NameBaxter Healthcare Corporation
Substance NameBUPIVACAINE HYDROCHLORIDE
Active Ingredient Strength8 mg/mL
Pharm ClassesAmide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 36000-092-10

10 AMPULE in 1 BLISTER PACK (36000-092-10) > 2 mL in 1 AMPULE
Marketing Start Date2016-08-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36000-092-05 [36000009205]

Bupivacaine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207266
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-08-08
Marketing End Date2018-04-20

NDC 36000-092-10 [36000009210]

Bupivacaine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207266
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-08-08

NDC 36000-092-25 [36000009225]

Bupivacaine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207266
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-08-08
Marketing End Date2018-04-20

Drug Details

Active Ingredients

IngredientStrength
BUPIVACAINE HYDROCHLORIDE7.5 mg/mL

OpenFDA Data

SPL SET ID:d2335583-1349-44ad-aac4-e9392533160c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1724784
  • Pharmacological Class

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