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
-
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 63323-505-74
FUM 4092 1x 250mL
Fresenius Kabi Rx only
freeflexAnticoagulant 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 ONLYNOT 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 HEATMANUFACTURING FACILITY/
MANUFACTURED BY
FRESENIUS KABI NORGE AS
NO-1753 HALDEN, NORWAY
MADE IN NOMANUFACTURER
FRESENIUS KABI AG
61346 BAD HOMBURG,
GERMANYTEL.: +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 solutionProduct 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)