NDC 25021-653

Ropivacaine Hydrochloride

Ropivacaine Hydrochloride

Ropivacaine Hydrochloride is a Epidural Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Sagent Pharmaceuticals. The primary component is Ropivacaine Hydrochloride.

Product ID25021-653_848068ef-487f-4329-b5f0-db70052faa1b
NDC25021-653
Product TypeHuman Prescription Drug
Proprietary NameRopivacaine Hydrochloride
Generic NameRopivacaine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationEPIDURAL
Marketing Start Date2014-09-23
Marketing End Date2019-07-31
Marketing CategoryANDA / ANDA
Application NumberANDA090318
Labeler NameSagent Pharmaceuticals
Substance NameROPIVACAINE HYDROCHLORIDE
Active Ingredient Strength10 mg/mL
Pharm ClassesAmide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC Exclude FlagN

Packaging

NDC 25021-653-20

5 VIAL in 1 CARTON (25021-653-20) > 20 mL in 1 VIAL
Marketing Start Date2014-09-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 25021-653-20 [25021065320]

Ropivacaine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA090318
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-09-23
Marketing End Date2019-07-31

Drug Details

Active Ingredients

IngredientStrength
ROPIVACAINE HYDROCHLORIDE10 mg/mL

OpenFDA Data

SPL SET ID:ed31f0cc-0282-485a-8a1a-d11524de4411
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1734084
  • 1734207
  • 905189
  • 1734475

    • Pharmacological Class

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

    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.