NDC 57826-455

Haemonetics Anticoagulant Citrate Phosphate Double Dextrose Solution (CP2D)

Citric Acid Monohydrate, Trisodium Citrate Dihydrate, Sodium Phosphate, Monobasic, Monohydrate, Anhydrous Dextrose

Haemonetics Anticoagulant Citrate Phosphate Double Dextrose Solution (CP2D) is a Extracorporeal Solution in the Human Prescription Drug category. It is labeled and distributed by Haemonetics Corporation. The primary component is Citric Acid Monohydrate; Trisodium Citrate Dihydrate; Sodium Phosphate, Monobasic, Monohydrate; Anhydrous Dextrose.

Product ID57826-455_6ad88922-a8f9-6674-e053-2991aa0a6697
NDC57826-455
Product TypeHuman Prescription Drug
Proprietary NameHaemonetics Anticoagulant Citrate Phosphate Double Dextrose Solution (CP2D)
Generic NameCitric Acid Monohydrate, Trisodium Citrate Dihydrate, Sodium Phosphate, Monobasic, Monohydrate, Anhydrous Dextrose
Dosage FormSolution
Route of AdministrationEXTRACORPOREAL
Marketing Start Date2013-01-10
Marketing CategoryNDA / NDA
Application NumberBN000127
Labeler NameHaemonetics Corporation
Substance NameCITRIC ACID MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ANHYDROUS DEXTROSE
Active Ingredient Strength33 mg/mL; mg/mL; mg/mL; mg/mL
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 Through2019-12-31

Packaging

NDC 57826-455-02

250 mL in 1 BAG (57826-455-02)
Marketing Start Date2013-01-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57826-455-02 [57826045502]

Haemonetics Anticoagulant Citrate Phosphate Double Dextrose Solution (CP2D) SOLUTION
Marketing CategoryNDA
Application NumberBN000127
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-01-10

Drug Details

Active Ingredients

IngredientStrength
CITRIC ACID MONOHYDRATE32.7 mg/mL

OpenFDA Data

SPL SET ID:1c149b86-5f9d-4e60-8f17-4ec03ca80563
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]

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