NDC | 0942-9505-10 |
Set ID | a63da38d-1fea-4ee0-a70b-55c891a5ebcc |
Category | Human Prescription Drug Label |
Packager | Fenwal, Inc. |
Generic Name | |
Product Class | Anti-coagulant |
Product Number | |
Application Number | BN770923 |
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PACKAGE/LABEL DISPLAY PANEL
Fenwal™
Anticoagulant Sodium Citrate Solution USP
Rx only
CODE 4B7867Q
NDC 0942-9505-10
250 mL
EACH 100 mL CONTAINS 4 g SODIUM CITRATE (DIHYDRATE) USP
pH ADJUSTED WITH CITRIC ACID
STERILE
NONPYROGENIC
FOR USE WITH CYTAPHERESIS DEVICE ONLY
NOT FOR DIRECT INTRAVENOUS INFUSION
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 TEMPERATUREPL 146 PLASTIC
MANUFACTURED BY:
BAXTER HEALTHCARE CORPORATION
DEERFIELD, IL 60015 USAMANUFACTURED FOR:
FENWAL, INC.
LAKE ZURICH, IL 60047 USAMADE IN USA
07-25-02-996 REV: C
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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:0942-9505 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 WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0942-9505-10 250 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 03/01/2007 Labeler - Fenwal, Inc. (794519020) Registrant - Fenwal, Inc. (794519020) Establishment Name Address ID/FEI Business Operations Fenwal International, Inc. 091164590 MANUFACTURE(0942-9505)