TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)

Product NDC
53877-001
11-digit product format
538770001
Labeler code
53877
Product ID
53877-001_ddc359d4-cffe-4f5c-8265-7e3893086d97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Terumo Corporation
Application
BN820528
Marketing category
NDA
Marketing start
2009-12-10
Marketing end
0000-00-00
Substance
ANHYDROUS CITRIC ACID; TRISODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; DEXTROSE MONOHYDRATE; ADENINE
Active strength
3 g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL
Pharmacologic classes
Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]
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
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53877-001-01TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)35 mL in 1 BAGSOLUTION356
53877-001-01TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)30 in 1 CASESOLUTION306
53877-001-02TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)30 in 1 CASESOLUTION304
53877-001-02TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)63 mL in 1 BAGSOLUTION634
53877-001-03TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)60 in 1 CASESOLUTION604
53877-001-03TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)63 mL in 1 BAGSOLUTION634
53877-001-11TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)63 mL in 1 BAGSOLUTION632
53877-001-11TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)30 in 1 CASESOLUTION302
53877-001-12TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)24 in 1 CASESOLUTION242
53877-001-12TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)63 mL in 1 BAGSOLUTION632
53877-001-13TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)70 mL in 1 BAGSOLUTION702
53877-001-13TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)30 in 1 CASESOLUTION302
53877-001-14TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)24 in 1 CASESOLUTION242
53877-001-14TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)70 mL in 1 BAGSOLUTION702

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AdenineACTIVE INGREDIENTJAC85A2161TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]4
Anhydrous Citric AcidACTIVE INGREDIENTXF417D3PSLTERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]4
Dextrose MonohydrateACTIVE INGREDIENTLX22YL083GTERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]4
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEACTIVE INGREDIENT593YOG76RNTERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]4
Trisodium Citrate DihydrateACTIVE INGREDIENTB22547B95KTERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]4
AdenineACTIVE MOIETYJAC85A2161TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]4
Anhydrous Citric AcidACTIVE MOIETYXF417D3PSLTERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]4
DextroseACTIVE MOIETYIY9XDZ35W2TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]4
PHOSPHATE IONACTIVE MOIETYNK08V8K8HRTERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]4
WaterINACTIVE INGREDIENT059QF0KO0RTERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]4
AdenineACTIVE INGREDIENTJAC85A2161TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]3
Anhydrous Citric AcidACTIVE INGREDIENTXF417D3PSLTERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]3
Dextrose MonohydrateACTIVE INGREDIENTLX22YL083GTERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]3
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEACTIVE INGREDIENT593YOG76RNTERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]3
Trisodium Citrate DihydrateACTIVE INGREDIENTB22547B95KTERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]3
AdenineACTIVE MOIETYJAC85A2161TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]3
Anhydrous Citric AcidACTIVE MOIETYXF417D3PSLTERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]3
DextroseACTIVE MOIETYIY9XDZ35W2TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]3
PHOSPHATE IONACTIVE MOIETYNK08V8K8HRTERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]3
WaterINACTIVE INGREDIENT059QF0KO0RTERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]3
AdenineACTIVE INGREDIENTJAC85A2161TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]1
Anhydrous Citric AcidACTIVE INGREDIENTXF417D3PSLTERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]1
Dextrose MonohydrateACTIVE INGREDIENTLX22YL083GTERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]1
Sodium Phosphate, Monobasic, MonohydrateACTIVE INGREDIENT593YOG76RNTERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]1
Trisodium Citrate DihydrateACTIVE INGREDIENTB22547B95KTERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]1
AdenineACTIVE MOIETYJAC85A2161TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]1
Anhydrous Citric AcidACTIVE MOIETYXF417D3PSLTERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]1
DextroseACTIVE MOIETYIY9XDZ35W2TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]1
Phosphate IonACTIVE MOIETYNK08V8K8HRTERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]1
WaterINACTIVE INGREDIENT059QF0KO0RTERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53877-001TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]6Legacy NDC, 2 package rows20181219_991fb1d2-eb44-4ab7-904e-79476b2190f0.zip
53877-001TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]4Legacy NDC, 4 package rows20181219_14b53ad8-3e44-401e-bd9b-ca81848a6b18.zip
53877-001TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)) SOLUTION [TERUMO CORPORATION]2Legacy NDC, 8 package rows20181219_123381eb-3b2a-4a9e-9ee7-f9d7aa7b8979.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53877-001-015387700010130 BAG in 1 CASE (53877-001-01) > 35 mL in 1 BAG30 bag2009-11-180000-00-00NoNoCurrent
53877-001-025387700010230 BAG in 1 CASE (53877-001-02) > 63 mL in 1 BAG30 bag2009-12-100000-00-00NoNoCurrent
53877-001-035387700010360 BAG in 1 CASE (53877-001-03) > 63 mL in 1 BAG60 bag2009-12-100000-00-00NoNoCurrent
53877-001-045387700010448 BAG in 1 CASE (53877-001-04) > 63 mL in 1 BAG48 bag2009-12-140000-00-00NoNoCurrent
53877-001-055387700010530 BAG in 1 CASE (53877-001-05) > 63 mL in 1 BAG30 bag2009-12-140000-00-00NoNoCurrent
53877-001-065387700010636 BAG in 1 CASE (53877-001-06) > 70 mL in 1 BAG36 bag2009-12-140000-00-00NoNoCurrent
53877-001-075387700010730 BAG in 1 CASE (53877-001-07) > 70 mL in 1 BAG30 bag2009-12-140000-00-00NoNoCurrent
53877-001-085387700010824 BAG in 1 CASE (53877-001-08) > 70 mL in 1 BAG24 bag2009-12-140000-00-00NoNoCurrent
53877-001-095387700010924 BAG in 1 CASE (53877-001-09) > 63 mL in 1 BAG24 bag2009-12-140000-00-00NoNoCurrent
53877-001-105387700011036 BAG in 1 CASE (53877-001-10) > 63 mL in 1 BAG36 bag2009-12-140000-00-00NoNoCurrent
53877-001-115387700011130 BAG in 1 CASE (53877-001-11) > 63 mL in 1 BAG30 bag2012-05-220000-00-00NoNoCurrent
53877-001-125387700011224 BAG in 1 CASE (53877-001-12) > 63 mL in 1 BAG24 bag2012-05-220000-00-00NoNoCurrent
53877-001-135387700011330 BAG in 1 CASE (53877-001-13) > 70 mL in 1 BAG30 bag2012-05-220000-00-00NoNoCurrent
53877-001-145387700011424 BAG in 1 CASE (53877-001-14) > 70 mL in 1 BAG24 bag2012-05-220000-00-00NoNoCurrent