NDC 57826-462

Haemonetics Additive Solution Formula 3 (AS-3)

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

Haemonetics Additive Solution Formula 3 (AS-3) 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; Sodium Phosphate, Monobasic, Monohydrate; Sodium Chloride; Adenine; Anhydrous Dextrose; Trisodium Citrate Dihydrate.

Product ID57826-462_6ad88922-a8dc-6674-e053-2991aa0a6697
NDC57826-462
Product TypeHuman Prescription Drug
Proprietary NameHaemonetics Additive Solution Formula 3 (AS-3)
Generic NameCitric Acid Monohydrate, Sodium Phosphate, Monobasic, Monohydrate, Sodium Chloride, Adenine, Anhydrous Dextrose, Trisodium Citrate Dihydrate
Dosage FormSolution
Route of AdministrationEXTRACORPOREAL
Marketing Start Date2013-01-07
Marketing CategoryNDA / NDA
Application NumberBN000127
Labeler NameHaemonetics Corporation
Substance NameCITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM CHLORIDE; ADENINE; ANHYDROUS DEXTROSE; TRISODIUM CITRATE DIHYDRATE
Active Ingredient Strength4 mg/mL; mg/mL; 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 57826-462-03

300 mL in 1 BAG (57826-462-03)
Marketing Start Date2013-01-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57826-462-03 [57826046203]

Haemonetics Additive Solution Formula 3 (AS-3) SOLUTION
Marketing CategoryNDA
Application NumberBN000127
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-01-07

Drug Details

Active Ingredients

IngredientStrength
CITRIC ACID MONOHYDRATE4.2 mg/mL

OpenFDA Data

SPL SET ID:e6775fa2-9f23-4d71-be07-1e9e4d6265d0
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 "Haemonetics Additive Solution Formula 3 (AS-3)" or generic name "Citric Acid Monohydrate, Sodium Phosphate, Monobasic, Monohydrate, Sodium Chloride, Adenine, Anhydrous Dextrose, Trisodium Citrate Dihydrate"

NDCBrand NameGeneric Name
57826-460Haemonetics Additive Solution Formula 3 (AS-3)CITRIC ACID MONOHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM CHLORIDE, ADENINE, ANHYDROUS DEXTROSE, TRISODIUM CITRATE DIHYDRATE
57826-462Haemonetics Additive Solution Formula 3 (AS-3)CITRIC ACID MONOHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM CHLORIDE, ADENINE, ANHYDROUS DEXTROSE, TRISODIUM CITRATE DIHYDRATE

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