NDC 65145-108

Ropivacaine Hydrochloride

Ropivacaine Hydrochloride

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

Product ID65145-108_a00e23b4-987f-4844-906d-4cc4823c7493
NDC65145-108
Product TypeHuman Prescription Drug
Proprietary NameRopivacaine Hydrochloride
Generic NameRopivacaine Hydrochloride
Dosage FormInjection
Route of AdministrationEPIDURAL; INFILTRATION; PERINEURAL
Marketing Start Date2020-04-24
Marketing CategoryANDA / ANDA
Application NumberANDA212808
Labeler NameCaplin Steriles Limited
Substance NameROPIVACAINE HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesAmide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 65145-108-10

10 VIAL in 1 CARTON (65145-108-10) > 20 mL in 1 VIAL (65145-108-01)
Marketing Start Date2020-04-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65145-108-01 [65145010801]

Ropivacaine Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA212808
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-24

NDC 65145-108-10 [65145010810]

Ropivacaine Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA212808
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-24

Drug Details

Active Ingredients

IngredientStrength
ROPIVACAINE HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:a9010ea8-0923-44e4-a7c7-7d65d37d06db
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1734084
  • 1734207
  • 1734483
  • 1734475
    • UPC Code
  • 0365145108012
  • 0365145110015
  • 0365145107015

    • 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
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