NDC 70069-067

Ropivacaine Hydrochloride

Ropivacaine Hydrochloride

Ropivacaine Hydrochloride is a Epidural Injection in the Human Prescription Drug category. It is labeled and distributed by Somerset Therapeutics, Llc. The primary component is Ropivacaine Hydrochloride.

Product ID70069-067_05d2eb61-2083-4555-9754-89320e33b50b
NDC70069-067
Product TypeHuman Prescription Drug
Proprietary NameRopivacaine Hydrochloride
Generic NameRopivacaine Hydrochloride
Dosage FormInjection
Route of AdministrationEPIDURAL
Marketing Start Date2018-06-15
Marketing CategoryANDA / ANDA
Application NumberANDA207636
Labeler NameSomerset Therapeutics, LLC
Substance NameROPIVACAINE HYDROCHLORIDE
Active Ingredient Strength10 mg/mL
Pharm ClassesAmide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 70069-067-25

25 VIAL in 1 CARTON (70069-067-25) > 20 mL in 1 VIAL (70069-067-01)
Marketing Start Date2018-06-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70069-067-01 [70069006701]

Ropivacaine Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA207636
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-15

NDC 70069-067-25 [70069006725]

Ropivacaine Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA207636
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-15

Drug Details

Active Ingredients

IngredientStrength
ROPIVACAINE HYDROCHLORIDE10 mg/mL

OpenFDA Data

SPL SET ID:ffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe64
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1734483
  • 1734207
  • 905189
  • 1734203
  • 1734084
  • 1734475
  • 1734090
    • UPC Code
  • 0370069065013
  • 0370069067017
  • 0370069064054
  • 0370069064016

    • 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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