Label: ACD-A- anticoagulant citrate dextrose solution a solution

  • NDC Code(s): 53157-796-08
  • Packager: Haemonetics Manufacturing Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 9, 2015

If you are a consumer or patient please visit this version.

View All Sections
  • DESCRIPTION

    Re-Order Product Code: 796-08

    750 mL volume. Single use container.

    Sterile, nonpyrogenic fluid path. Sterilized by steam.

    Store at room temperature.

  • INDICATIONS AND USAGE

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

  • CONTRAINDICATIONS

    Not for direct intravenous infusion.

  • WARNINGS

    Avoid excessive heat. Protect from freezing.

  • 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

    750 mL volume bag.

    Each 100 ml contains:

    0.73 g citric acid (anhydrous), USP

    2.20 g sodium citrate (dihydrate), USP

    2.45 g dextrose (monohydrate), USP

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Hot Stamped Bag

    796-08 Hot Stamped Bag

    Envelope Label

    796-08 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
    ACD-A 
    anticoagulant citrate dextrose solution a solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53157-796
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE2.45 g  in 100 mL
    SODIUM CITRATE (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) SODIUM CITRATE2.20 g  in 100 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID0.73 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53157-796-0812 in 1 CARTON
    1750 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA71049711/06/1987
    Labeler - Haemonetics Manufacturing Inc (078598396)
    Registrant - Haemonetics Manufacturing Inc (078598396)
    Establishment
    NameAddressID/FEIBusiness Operations
    Haemonetics Manufacturing Inc078598396MANUFACTURE(53157-796)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Label Archives, RxNorm, Get Label RSS Feed