Label: ANTICOAGULANT SODIUM CITRATE- sodium citrate solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated May 20, 2011

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  • ANTICOAGULANT SODIUM CITRATE SOLUTION, USP

    Sterile, non-pyrogenic fluid path. Sterilized by steam.

    Rx only.

    250 ml volume bag.

    Store at room temperature.

  • INDICATIONS AND USAGE

    For use with automated plasmapheresis equipment only. Use according to equipment manufacturer’s instructions. This unit should be used for plasmapheresis only.

  • WARNINGS

    Not for direct intravenous infusion.

    DO NOT VENT.

    Avoid excessive heat. Protect from freezing.

  • GENERAL PRECAUTIONS

    Do not use unless solution is clear and no leaks are detected.

    Discard unused portion.

  • HOW SUPPLIED

    Single Use Container.

  • INFORMATION FOR PATIENTS

    Medsep Corporation, A Subsidiary of Pall Corp., Covina, CA 91722, USA

    Visit us at www.pall.com/medical

    For Pall customer service, call: 1.800.645.6578

  • CONTAINER TEXT DISPLAYED

    Sodium Citrate Bag Text

    Anticoagulant Sodium Citrate Bag Text

    ANTICOAGULANT SODIUM CITRATE SOLUTION, USP

    250 mL Code 798-60

    For use with automated plasmapheresis equipment only. Each 250 mL of anticoagulant contains 10.0 g sodium citrate (dihydrate), USP (pH adjusted with citric acid, USP).

    CAUTION: Not for direct intravenous infusion.

    Do not use unless anticoagulant is clear. This unit should be used for plasmapheresis only. Sterile, nonpyrogenic fluid path. Sterilized by steam. Rx Only.

    DO NOT VENT.

    Issued August 2010, 147798603

  • INGREDIENTS AND APPEARANCE
    ANTICOAGULANT SODIUM CITRATE 
    sodium citrate solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62646-798
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CITRATE (UNII: 1Q73Q2JULR) (CITRIC ACID ANHYDROUS - UNII:XF417D3PSL) SODIUM CITRATE10 g  in 250 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62646-798-60250 mL in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA76030504/15/2011
    Labeler - Medsep Corporation (928224765)
    Registrant - Medsep Corporation (928224765)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medsep Corporation928224765manufacture, relabel, repack
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