NDC 53157-736

Leukotrap WB System

Cpda-1 Blood Bag Collection System

Leukotrap WB System is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Haemonetics Manufacturing Inc. The primary component is Dextrose Monohydrate; Sodium Citrate; Citric Acid Monohydrate; Sodium Phosphate, Monobasic, Monohydrate; Adenine.

Product ID53157-736_744a75d7-c324-4999-80c6-50612d067835
NDC53157-736
Product TypeHuman Prescription Drug
Proprietary NameLeukotrap WB System
Generic NameCpda-1 Blood Bag Collection System
Dosage FormSolution
Route of AdministrationINTRAVENOUS
Marketing Start Date1980-11-06
Marketing CategoryNDA / NDA
Application NumberNDA800077
Labeler NameHaemonetics Manufacturing Inc
Substance NameDEXTROSE MONOHYDRATE; SODIUM CITRATE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE
Active Ingredient Strength2 g/63mL; g/63mL; g/63mL; g/63mL; g/63mL
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]
DEA ScheduleCII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 53157-736-94

18 BAG in 1 CARTON (53157-736-94) > 63 mL in 1 BAG
Marketing Start Date1980-11-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53157-736-94 [53157073694]

Leukotrap WB System SOLUTION
Marketing CategoryNDA
Application NumberBN800077
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1980-11-06

NDC 53157-736-92 [53157073692]

Leukotrap WB System SOLUTION
Marketing CategoryNDA
Application NumberBN800077
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1980-11-06

Drug Details

Active Ingredients

IngredientStrength
DEXTROSE MONOHYDRATE2.01 g/63mL

OpenFDA Data

SPL SET ID:b2064cb0-542d-41d4-82ef-e7e6a53b9400
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]

NDC Crossover Matching brand name "Leukotrap WB System" or generic name "Cpda-1 Blood Bag Collection System"

NDCBrand NameGeneric Name
53157-136Leukotrap WB SystemCPDA-1 Blood Bag Collection System
53157-262Leukotrap WB SystemLeukotrap WB System
53157-736Leukotrap WB SystemCPDA-1 Blood Bag Collection System

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.