Label: SODIUM CITRATE BLOOD-PACK UNITS, (PL 146 PLASTIC)- anticoagulant sodium citrate solution solution
- NDC Code(s): 0942-9506-25
- Packager: Fenwal, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 7, 2022
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- Anticoagulant Sodium Citrate Solution USP
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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
CODE 6B7801
NDC 0942-9506-25
250mLFresenius Kabi Rx only
ANTICOAGULANT SODIUM CITRATE SOLUTION USP
NOT FOR DIRECT INTRAVENOUS INFUSION
EACH 100 mL CONTAINS 4 g SODIUM CITRATE (DIHYDRATE) USP
pH ADJUSTED WITH CITRIC ACID
STERILE NONPYROGENIC FOR USE WITH APHERESIS DEVICE ONLY
SINGLE USE CONTAINER DISCARD UNUSED PORTION DO NOT USE
UNLESS SOLUTION IS CLEAR AND NO LEAKS ARE DETECTED
AFTER REMOVING OVERWRAP CHECK FOR MINUTE LEAKS BY SQUEEZING
INNER BAG FIRMLY IF LEAKS ARE FOUND DISCARD SOLUTION AS
STERILITY MAY BE IMPAIRED
CAUTION – DO NOT REMOVE UNIT FROM OVERWRAP UNTIL READY
FOR USE THE OVERWRAP IS A MOISTURE BARRIER THE INNER BAG
MAINTAINS THE STERILITY OF THE PRODUCT STORE AT CONTROLLED
ROOM TEMPERATURE
FRESENIUS KABI AG
61346 BAD HOMBURG / GERMANYTEL.: +49 (0)6172 686-0
www.fresenius-kabi.com
Made in MX 47-25-13-348 REV: A
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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:0942-9506 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:0942-9506-25 250 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 - Fenwal, Inc. (794519020) Establishment Name Address ID/FEI Business Operations Fresenius Medical Care de Mexico, S.A. de C.V. 812652287 ANALYSIS(0942-9506) , STERILIZE(0942-9506) , LABEL(0942-9506) , MANUFACTURE(0942-9506) , PACK(0942-9506)