SODIUM CITRATE BLOOD PACK UNITS, (PL 146 PLASTIC)- anticoagulant sodium citrate solution solution 
Fresenius Kabi USA, LLC

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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

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
NDABN77092309/29/201404/10/2023
Labeler - Fresenius Kabi USA, LLC (608775388)
Registrant - Fresenius Kabi USA, LLC (608775388)
Establishment
NameAddressID/FEIBusiness Operations
Fresenius Kabi Norge AS731170932MANUFACTURE(63323-505)

Revised: 4/2023
 
Fresenius Kabi USA, LLC