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

Sodium Citrate Blood by

Drug Labeling and Warnings

Sodium Citrate Blood by is a Prescription medication manufactured, distributed, or labeled by Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SODIUM CITRATE BLOOD  PACK UNITS, (PL 146 PLASTIC)
anticoagulant sodium citrate solution solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 63323-505
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63323-505-74	250 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	BN770923	09/29/2014

Labeler - Fresenius Kabi USA, LLC (608775388)

Registrant - Fresenius Kabi USA, LLC (608775388)

Establishment
Name	Address	ID/FEI	Business Operations
Fresenius Kabi Norge AS		731170932	MANUFACTURE(63323-505)