FDA.reportPublic FDA data

TERUFLEX Blood Bag System with Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative

Product NDC
53877-009
11-digit product format
538770009
Labeler code
53877
Product ID
53877-009_89f94557-3a16-4a36-9766-4d03d9defd79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anticoagulant Citrate Phosphate Dextrose (CPD) AND AS-5 Red Cell Preservative
Dosage form
KIT
Route
INTRAVENOUS
Labeler
Terumo Corporation
Application
BN880217
Marketing category
NDA
Marketing start
2010-05-05
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53877-009-412025-01-30C16284748780-12cef2736-98b8-d83d-e063-dadaa90ab31fTERUFLEX® BLOOD BAG SYSTEM WITH BLOOD SAMPLING ARM® CPD/OPTISOL® SOLUTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53877-009-41TERUFLEX Blood Bag System with Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative24 in 1 CASEKIT246
53877-009-41TERUFLEX Blood Bag System with Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative1 in 1 BAGKIT16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AdenineACTIVE INGREDIENTJAC85A2161TERUFLEX BLOOD BAG SYSTEM WITH BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]3
Anhydrous Citric AcidACTIVE INGREDIENTXF417D3PSLTERUFLEX BLOOD BAG SYSTEM WITH BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]3
Dextrose MonohydrateACTIVE INGREDIENTLX22YL083GTERUFLEX BLOOD BAG SYSTEM WITH BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]3
MannitolACTIVE INGREDIENT3OWL53L36ATERUFLEX BLOOD BAG SYSTEM WITH BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]3
Sodium ChlorideACTIVE INGREDIENT451W47IQ8XTERUFLEX BLOOD BAG SYSTEM WITH BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]3
Sodium Phosphate, MonobasicACTIVE INGREDIENT3980JIH2SWTERUFLEX BLOOD BAG SYSTEM WITH BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]3
Trisodium Citrate DihydrateACTIVE INGREDIENTB22547B95KTERUFLEX BLOOD BAG SYSTEM WITH BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]3
AdenineACTIVE MOIETYJAC85A2161TERUFLEX BLOOD BAG SYSTEM WITH BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]3
Citric AcidACTIVE MOIETY2968PHW8QPTERUFLEX BLOOD BAG SYSTEM WITH BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]3
DextroseACTIVE MOIETYIY9XDZ35W2TERUFLEX BLOOD BAG SYSTEM WITH BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]3
MannitolACTIVE MOIETY3OWL53L36ATERUFLEX BLOOD BAG SYSTEM WITH BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]3
Phosphoric AcidACTIVE MOIETYE4GA8884NNTERUFLEX BLOOD BAG SYSTEM WITH BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]3
SODIUM CATIONACTIVE MOIETYLYR4M0NH37TERUFLEX BLOOD BAG SYSTEM WITH BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]3
WaterINACTIVE INGREDIENT059QF0KO0RTERUFLEX BLOOD BAG SYSTEM WITH BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53877-009TERUFLEX BLOOD BAG SYSTEM WITH BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]6Legacy NDC, 2 package rows20191217_7a1ce6e8-68fb-4cf0-99a2-f460246a2ba8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53877-009-315387700093124 BAG in 1 CASE (53877-009-31) > 1 KIT in 1 BAG * 63 mL in 1 BAG * 100 mL in 1 BAG24 bag2010-05-050000-00-00NoNoCurrent
53877-009-415387700094124 BAG in 1 CASE (53877-009-41) > 1 KIT in 1 BAG * 70 mL in 1 BAG * 111 mL in 1 BAG24 bag2010-05-050000-00-00NoNoCurrent