Label: ANTICOAGULANT SODIUM CITRATE- sodium citrate solution
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Contains inactivated NDC Code(s)
NDC Code(s): 62646-798-60 - Packager: Medsep Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated May 20, 2011
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- ANTICOAGULANT SODIUM CITRATE SOLUTION, USP
- INDICATIONS AND USAGE
- WARNINGS
- GENERAL PRECAUTIONS
- HOW SUPPLIED
- INFORMATION FOR PATIENTS
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CONTAINER TEXT DISPLAYED
ANTICOAGULANT SODIUM CITRATE SOLUTION, USP
For use with automated plasmapheresis equipment only. Each 250 mL of anticoagulant contains 10.0 g sodium citrate (dihydrate), USP (pH adjusted with citric acid, USP).
CAUTION: Not for direct intravenous infusion.
Do not use unless anticoagulant is clear. This unit should be used for plasmapheresis only. Sterile, nonpyrogenic fluid path. Sterilized by steam. Rx Only.
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INGREDIENTS AND APPEARANCE
ANTICOAGULANT SODIUM CITRATE
sodium citrate solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62646-798 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CITRATE (UNII: 1Q73Q2JULR) (CITRIC ACID ANHYDROUS - UNII:XF417D3PSL) SODIUM CITRATE 10 g in 250 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62646-798-60 250 mL in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA760305 04/15/2011 Labeler - Medsep Corporation (928224765) Registrant - Medsep Corporation (928224765) Establishment Name Address ID/FEI Business Operations Medsep Corporation 928224765 manufacture, relabel, repack