NDC 52584-286

NAROPIN

Ropivacaine Hydrochloride

NAROPIN is a Epidural; Infiltration; Perineural Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc. The primary component is Ropivacaine Hydrochloride.

Product ID52584-286_18b9c3f9-6ebf-4dcb-a5fd-5ac424f6ab0b
NDC52584-286
Product TypeHuman Prescription Drug
Proprietary NameNAROPIN
Generic NameRopivacaine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationEPIDURAL; INFILTRATION; PERINEURAL
Marketing Start Date2014-03-11
Marketing CategoryNDA / NDA
Application NumberNDA020533
Labeler NameGeneral Injectables & Vaccines, Inc
Substance NameROPIVACAINE HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesAmide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52584-286-35

1 VIAL, SINGLE-DOSE in 1 BAG (52584-286-35) > 30 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2014-03-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-286-35 [52584028635]

NAROPIN INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020533
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-03-11

Drug Details

Active Ingredients

IngredientStrength
ROPIVACAINE HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:096c2693-8488-48c2-88ee-bf3df95c3f4c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1734475
  • 1734476

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0404-9924NAROPINropivacaine hydrochloride
    52584-286NAROPINNAROPIN
    63323-285NaropinNaropin
    63323-286NaropinNaropin
    63323-287NaropinNaropin
    63323-288NaropinNaropin
    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

    Trademark Results [NAROPIN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NAROPIN
    NAROPIN
    78276844 not registered Dead/Abandoned
    AstraZeneca AB
    2003-07-21
    NAROPIN
    NAROPIN
    75229359 2130448 Live/Registered
    FRESENIUS KABI USA, LLC
    1997-01-22
    NAROPIN
    NAROPIN
    75085662 2148189 Live/Registered
    FRESENIUS KABI USA, LLC
    1996-04-09
    NAROPIN
    NAROPIN
    74716292 not registered Dead/Abandoned
    ASTRA AKTIEBOLAG
    1995-08-16
    NAROPIN
    NAROPIN
    74581013 2061834 Dead/Cancelled
    ABRAXIS BIOSCIENCES, INC.
    1994-10-03
    NAROPIN
    NAROPIN
    74157414 not registered Dead/Abandoned
    AKTIEBOLAGET ASTRA
    1991-04-12
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