SODIUM CITRATE BLOOD-PACK UNITS, (PL 146 PLASTIC) (ANTICOAGULANT SODIUM CITRATE SOLUTION) SOLUTION [FRESENIUS KABI USA, LLC]

SODIUM CITRATE BLOOD-PACK UNITS, (PL 146 PLASTIC) (ANTICOAGULANT SODIUM CITRATE SOLUTION) SOLUTION [FRESENIUS KABI USA, LLC]
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NDC 63323-505-74
Set ID ccec1a48-d2f4-4130-93d9-d68502321b1d
Category Human Prescription Drug Label
Packager Fresenius Kabi USA, LLC
Generic Name
Product Class Anti-coagulant
Product Number
Application Number BN770923
  • Anticoagulant Sodium Citrate Solution USP

    A standalone direction insert does not exist for this product.

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    NDC 63323-505-74

    FUM 4092   1x    250mL

    Fresenius Kabi    Rx only
    freeflex

    Anticoagulant Sodium Citrate Solution, USP

    EACH 100 mL CONTAINS 4 g SODIUM CITRATE
    (DIHYDRATE) USP  pH ADJUSTED WITH CITRIC ACID
    STERILIZED USING STEAM  STERILE FLUID PATH
    NONPYROGENIC  FOR USE WITH CYTAPHERESIS
    DEVICE ONLY

    NOT FOR DIRECT INTRAVENOUS INFUSION
    DO NOT REUSE  DO NOT VENT  DISCARD UNUSED
    PORTION  DO NOT USE UNLESS SOLUTION IS
    CLEAR  DO NOT USE IF PRODUCT STERILE BARRIER
    SYSTEM IS COMPROMISED  AFTER REMOVING
    OVERWRAP CHECK FOR MINUTE LEAKS BY
    SQUEEZING INNER BAG FIRMLY  IF LEAKS ARE
    FOUND DISCARD SOLUTION AS STERILITY MAY BE
    IMPAIRED  REMOVE RED TAB FOR PRODUCT USE
    DO NOT USE IF TABS ARE DAMAGED
    CAUTION–DO NOT REMOVE UNIT FROM OVERWRAP
    UNTIL READY FOR USE
    THE OVERWRAP IS A MOISTURE BARRIER
    THE INNER BAG MAINTAINS STERILITY OF
    THE PRODUCT   STORE AT CONTROLLED ROOM
    TEMPERATURE
    PROTECT FROM FREEZING. AVOID EXCESSIVE HEAT

    MANUFACTURING FACILITY/
    MANUFACTURED BY
    FRESENIUS KABI NORGE AS
    NO-1753 HALDEN, NORWAY
    MADE IN NO

    MANUFACTURER
    FRESENIUS KABI AG
    61346 BAD HOMBURG,
    GERMANY

    TEL.: +49 (0)6172 686 0
    www.fresenius-kabi.com
    FUM 4092  01-69-19-001
    image01

  • INGREDIENTS AND APPEARANCE
    SODIUM CITRATE BLOOD  PACK UNITS, (PL 146 PLASTIC)
    anticoagulant sodium citrate solution solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-505
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63323-505-74250 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDABN77092309/29/2014
    Labeler - Fresenius Kabi USA, LLC (608775388)
    Registrant - Fresenius Kabi USA, LLC (608775388)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fresenius Kabi Norge AS731170932MANUFACTURE(63323-505)

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