NDC 17478-081

Ropivacaine Hydrochloride

Ropivacaine Hydrochloride

Ropivacaine Hydrochloride is a Epidural; Infiltration; Perineural Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Akorn. The primary component is Ropivacaine Hydrochloride.

Product ID17478-081_33a30541-92c1-4971-9d49-da4425274d25
NDC17478-081
Product TypeHuman Prescription Drug
Proprietary NameRopivacaine Hydrochloride
Generic NameRopivacaine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationEPIDURAL; INFILTRATION; PERINEURAL
Marketing Start Date2016-04-11
Marketing CategoryANDA / ANDA
Application NumberANDA203955
Labeler NameAkorn
Substance NameROPIVACAINE HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesAmide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 17478-081-30

1 VIAL, SINGLE-DOSE in 1 CARTON (17478-081-30) > 30 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2016-04-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17478-081-30 [17478008130]

Ropivacaine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA203955
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-04-11

Drug Details

Active Ingredients

IngredientStrength
ROPIVACAINE HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:187fccbf-329a-4af1-a16e-f13c0e2bd73d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1734475
    • UPC Code
  • 0317478081302

    • Pharmacological Class

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

    Medicade Reported Pricing

    17478081130 LIDOCAINE HCL 2% JELLY

    Pricing Unit: ML | Drug Type:

    17478081110 LIDOCAINE HCL 2% JELLY

    Pricing Unit: ML | Drug Type:

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

    NDCBrand NameGeneric Name
    0143-9263Ropivacaine HydrochlorideRopivacaine Hydrochloride
    0143-9264Ropivacaine HydrochlorideRopivacaine Hydrochloride
    0143-9265Ropivacaine HydrochlorideRopivacaine Hydrochloride
    0143-9266Ropivacaine HydrochlorideRopivacaine Hydrochloride
    0409-9300Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDE
    0409-9301Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDE
    0409-9302Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDE
    0409-9303Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDE
    0781-3140Ropivacaine HydrochlorideRopivacaine Hydrochloride
    0781-3142Ropivacaine HydrochlorideRopivacaine Hydrochloride
    17478-081Ropivacaine HydrochlorideRopivacaine Hydrochloride
    17478-082Ropivacaine HydrochlorideRopivacaine Hydrochloride
    25021-652ropivacaine hydrochlorideropivacaine hydrochloride
    25021-653Ropivacaine Hydrochlorideropivacaine hydrochloride
    25021-671ropivacaine hydrochlorideropivacaine hydrochloride
    70069-062Ropivacaine HydrochlorideRopivacaine Hydrochloride
    70069-064Ropivacaine HydrochlorideRopivacaine Hydrochloride
    70069-066Ropivacaine HydrochlorideRopivacaine Hydrochloride
    70069-065Ropivacaine HydrochlorideRopivacaine Hydrochloride
    70069-061Ropivacaine HydrochlorideRopivacaine Hydrochloride
    70069-067Ropivacaine HydrochlorideRopivacaine Hydrochloride
    70069-063Ropivacaine HydrochlorideRopivacaine Hydrochloride
    55150-196Ropivacaine HydrochlorideRopivacaine Hydrochloride
    55150-199Ropivacaine HydrochlorideRopivacaine Hydrochloride
    55150-195Ropivacaine HydrochlorideRopivacaine Hydrochloride
    55150-197Ropivacaine HydrochlorideRopivacaine Hydrochloride
    55150-201Ropivacaine HydrochlorideRopivacaine Hydrochloride
    55150-200Ropivacaine HydrochlorideRopivacaine Hydrochloride
    55150-198Ropivacaine HydrochlorideRopivacaine Hydrochloride
    67457-878Ropivacaine HydrochlorideRopivacaine Hydrochloride
    67457-876Ropivacaine HydrochlorideRopivacaine Hydrochloride
    67457-877Ropivacaine HydrochlorideRopivacaine Hydrochloride
    67457-875Ropivacaine HydrochlorideRopivacaine Hydrochloride
    0404-9924NAROPINropivacaine hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.