READYFUSOR ROPIVACAINE FIXED RATE DELIVERY SYSTEM (ROPIVACAINE HYDROCHLORIDE ANHYDROUS) INJECTION, SOLUTION [BIOQ PHARMA INCORPORATED]

READYFUSOR ROPIVACAINE FIXED RATE DELIVERY SYSTEM (ROPIVACAINE HYDROCHLORIDE ANHYDROUS) INJECTION, SOLUTION [BIOQ PHARMA INCORPORATED]
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NDC 71807-011-01
Set ID f3981363-109c-4e3a-aed3-3e18e4c13eb6
Category HUMAN PRESCRIPTION DRUG LABEL
Packager BioQ Pharma Incorporated
Generic Name
Product Class Amide Local Anesthetic
Product Number
Application Number
  • PRINCIPAL DISPLAY PANEL - 250 mL Bottle Carton

    GALEN
    Distributed by:
    Galen Limited
    Craigavon
    BT63 5UA
    UK

    Ropivacaine
    ReadyfusOR
    Infusion pump

    Ropivacaine 2 mg/ml Solution for Infusion in Administration System

    Ropivacaine Hydrochloride
    250 ml
    5 ml/hr

    PRINCIPAL DISPLAY PANEL - 250 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    READYFUSOR ROPIVACAINE  FIXED RATE DELIVERY SYSTEM
    ropivacaine hydrochloride anhydrous injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71807-011
    Route of AdministrationINFILTRATION
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ROPIVACAINE HYDROCHLORIDE ANHYDROUS (UNII: 35504LBE2T) (ROPIVACAINE - UNII:7IO5LYA57N) ROPIVACAINE HYDROCHLORIDE ANHYDROUS2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71807-011-011 in 1 BOX03/05/2018
    1250 mL in 1 BOTTLE, DISPENSING; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    EXPORT ONLY03/05/2018
    Labeler - BioQ Pharma Incorporated (783975480)
    Establishment
    NameAddressID/FEIBusiness Operations
    Holopack Verpackungstechnik (DE)343390324MANUFACTURE(71807-011)
    Establishment
    NameAddressID/FEIBusiness Operations
    Steris AST (Frmrly Synergy San Diego)173008660STERILIZE(71807-011)
    Establishment
    NameAddressID/FEIBusiness Operations
    Steris AST (Frmrly Synergy Daventry )214479987STERILIZE(71807-011)
    Establishment
    NameAddressID/FEIBusiness Operations
    A&M Stabtest (Mainz, DE)341843679ANALYSIS(71807-011)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pioneer Agro Industries677604359API MANUFACTURE(71807-011)

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