Label: SODIUM CITRATE- anticoagulant sodium citrate solution solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CII
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 9, 2015

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  • DESCRIPTION

    Re-Order Product Code: 798-60

    250 mL volume. Single use container.

    Sterile, nonpyrogenic fluid path. Sterilized by steam.

    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.

  • CONTRAINDICATIONS

    Not for direct intravenous infusion.

  • WARNINGS

    Avoid excessive heat. Protect from freezing. Do NOT vent.

  • PRECAUTIONS

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

    General

    Rx only. Discard unused portion.

    Recommended Storage: Store at room temperature (25°C / 77°F).

  • HOW SUPPLIED

    250 mL volume bag.

    Each 250 ml contains:

    10.0 g sodium citrate (dihydrate), USP

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Bag Label

    798-60 Bag Label

    Envelope Label

    798-60 Envelope Label
  • References

    HAEMONETICS and THE Blood Management Company are trademarks of Haemonetics Corporation.

    Manufactured for:

    Haemonetics Corporation

    400 Wood Road

    Braintree, MA 02184, USA

    By: Haemonetics Manufacturing Inc.

    1630 Industrial Park Street

    Covina, CA 91722, USA

  • INGREDIENTS AND APPEARANCE
    SODIUM CITRATE 
    anticoagulant sodium citrate solution solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53157-798
    Route of AdministrationINTRAVENOUSDEA ScheduleCII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CITRATE (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) SODIUM CITRATE10.0 g  in 250 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53157-798-6036 in 1 CARTON
    1250 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA76030506/30/1978
    Labeler - Haemonetics Manufacturing Inc (078598396)
    Registrant - Haemonetics Manufacturing Inc (078598396)
    Establishment
    NameAddressID/FEIBusiness Operations
    Haemonetics Manufacturing Inc078598396MANUFACTURE(53157-798) , STERILIZE(53157-798) , LABEL(53157-798)
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