NDC 53877-001

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

Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)

TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Terumo Corporation. The primary component is Anhydrous Citric Acid; Trisodium Citrate Dihydrate; Sodium Phosphate, Monobasic, Monohydrate; Dextrose Monohydrate; Adenine.

Product ID53877-001_05957b63-ef61-4c95-b683-7bb697ae2a89
NDC53877-001
Product TypeHuman Prescription Drug
Proprietary NameTERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)
Generic NameAnticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)
Dosage FormSolution
Route of AdministrationINTRAVENOUS
Marketing Start Date2012-05-22
Marketing CategoryNDA / NDA
Application NumberBN820528
Labeler NameTerumo Corporation
Substance NameANHYDROUS CITRIC ACID; TRISODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; DEXTROSE MONOHYDRATE; ADENINE
Active Ingredient Strength3 g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL
Pharm ClassesAcidifying 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 FlagN
Listing Certified Through2020-12-31

Packaging

NDC 53877-001-11

30 BAG in 1 CASE (53877-001-11) > 63 mL in 1 BAG
Marketing Start Date2012-05-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53877-001-07 [53877000107]

TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) SOLUTION
Marketing CategoryNDA
Application NumberBN820528
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-14

NDC 53877-001-09 [53877000109]

TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) SOLUTION
Marketing CategoryNDA
Application NumberBN820528
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-16

NDC 53877-001-02 [53877000102]

TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) SOLUTION
Marketing CategoryNDA
Application NumberBN820528
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-10

NDC 53877-001-04 [53877000104]

TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) SOLUTION
Marketing CategoryNDA
Application NumberBN820528
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-14

NDC 53877-001-01 [53877000101]

TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) SOLUTION
Marketing CategoryNDA
Application NumberBN820528
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-18

NDC 53877-001-14 [53877000114]

TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) SOLUTION
Marketing CategoryNDA
Application NumberBN820528
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-05-22

NDC 53877-001-03 [53877000103]

TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) SOLUTION
Marketing CategoryNDA
Application NumberBN820528
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-10

NDC 53877-001-06 [53877000106]

TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) SOLUTION
Marketing CategoryNDA
Application NumberBN820528
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-14

NDC 53877-001-10 [53877000110]

TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) SOLUTION
Marketing CategoryNDA
Application NumberBN820528
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-16

NDC 53877-001-08 [53877000108]

TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) SOLUTION
Marketing CategoryNDA
Application NumberBN820528
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-14

NDC 53877-001-05 [53877000105]

TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) SOLUTION
Marketing CategoryNDA
Application NumberBN820528
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-14

NDC 53877-001-12 [53877000112]

TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) SOLUTION
Marketing CategoryNDA
Application NumberBN820528
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-05-22

NDC 53877-001-13 [53877000113]

TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) SOLUTION
Marketing CategoryNDA
Application NumberBN820528
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-05-22

NDC 53877-001-11 [53877000111]

TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) SOLUTION
Marketing CategoryNDA
Application NumberBN820528
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-05-22

Drug Details

Active Ingredients

IngredientStrength
ANHYDROUS CITRIC ACID2.99 g/1000mL

OpenFDA Data

SPL SET ID:6b6f4a15-7bb0-4092-b43d-b423f14ec12f
Manufacturer
UNII

Pharmacological Class

  • 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]
  • 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]

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