NDC 0781-3142

Ropivacaine Hydrochloride

Ropivacaine Hydrochloride

Ropivacaine Hydrochloride is a Parenteral Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Ropivacaine Hydrochloride.

Product ID0781-3142_b48c183c-69f9-411c-a27b-9e31b3876ede
NDC0781-3142
Product TypeHuman Prescription Drug
Proprietary NameRopivacaine Hydrochloride
Generic NameRopivacaine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationPARENTERAL
Marketing Start Date2014-07-24
Marketing CategoryANDA / ANDA
Application NumberANDA078601
Labeler NameSandoz Inc
Substance NameROPIVACAINE HYDROCHLORIDE
Active Ingredient Strength10 mg/mL
Pharm ClassesAmide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0781-3142-14

5 CARTON in 1 BOX (0781-3142-14) > 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3142-80) > 20 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2014-07-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-3142-80 [00781314280]

Ropivacaine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078601
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-07-24

NDC 0781-3142-14 [00781314214]

Ropivacaine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078601
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-07-24
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ROPIVACAINE HYDROCHLORIDE10 mg/mL

OpenFDA Data

SPL SET ID:05b3b09e-e54c-4933-8913-5279d04b521d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1734084
  • 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
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