NDC 53877-010

imuflex wb-sp blood bag system with integral whole blood leukocyte reduction filter (saving platelets) with diversion blood sampling arm

Anticoagulant Citrate Phosphate Dextrose (cpd)

imuflex wb-sp blood bag system with integral whole blood leukocyte reduction filter (saving platelets) with diversion blood sampling arm is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Terumo Corporation. The primary component is Dextrose Monohydrate; Trisodium Citrate Dihydrate; Anhydrous Citric Acid; Sodium Phosphate, Monobasic, Unspecified Form.

Product ID53877-010_6e111a6a-8eaa-4efa-88f5-61f06f5c1e46
NDC53877-010
Product TypeHuman Prescription Drug
Proprietary Nameimuflex wb-sp blood bag system with integral whole blood leukocyte reduction filter (saving platelets) with diversion blood sampling arm
Generic NameAnticoagulant Citrate Phosphate Dextrose (cpd)
Dosage FormSolution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-02-11
Marketing CategoryNDA / NDA
Application NumberBN880217
Labeler NameTerumo Corporation
Substance NameDEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
Active Ingredient Strength2 g/70mL; g/70mL; mg/70mL; mg/70mL
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 Through2021-12-31

Packaging

NDC 53877-010-01

10 POUCH in 1 CARTON (53877-010-01) > 1 BAG in 1 POUCH > 70 mL in 1 BAG
Marketing Start Date2019-02-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53877-010-01 [53877001001]

IMUFLEX WB-SP BLOOD BAG SYSTEM with Integral Whole Blood Leukocyte Reduction Filter (Saving Platelets) with Diversion Blood Sampling Arm SOLUTION
Marketing CategoryNDA
Application NumberBN880217
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-11

Drug Details

Active Ingredients

IngredientStrength
DEXTROSE MONOHYDRATE1.79 g/70mL

OpenFDA Data

SPL SET ID:4d08424e-1ae1-41a4-b50b-e4ce4b828bdd
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]

NDC Crossover Matching brand name "imuflex wb-sp blood bag system with integral whole blood leukocyte reduction filter (saving platelets) with diversion blood sampling arm" or generic name "Anticoagulant Citrate Phosphate Dextrose (cpd)"

NDCBrand NameGeneric Name
53877-010imuflex wb-sp blood bag system with integral whole blood leukocyte reduction filter (saving platelets) with diversion blood sampling armAnticoagulant Citrate Phosphate Dextrose (CPD)
0942-9202Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticAnticoagulant Citrate Phosphate Dextrose (CPD)
0942-9206CPDAnticoagulant Citrate Phosphate Dextrose (CPD)

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