NDC 14537-828

Additive Formula 3

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

Additive Formula 3 is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Terumo Bct, Ltd. The primary component is Dextrose Monohydrate; Trisodium Citrate Dihydrate; Sodium Chloride; Sodium Phosphate, Monobasic, Monohydrate; Citric Acid Monohydrate; Adenine.

Product ID14537-828_3973708b-e5a7-47f5-829c-5e3ae9620dd8
NDC14537-828
Product TypeHuman Prescription Drug
Proprietary NameAdditive Formula 3
Generic NameDextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine
Dosage FormSolution
Route of AdministrationINTRAVENOUS
Marketing Start Date2002-05-29
Marketing CategoryNDA / NDA
Application NumberBN001214
Labeler NameTerumo BCT, Ltd
Substance NameDEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; CITRIC ACID MONOHYDRATE; ADENINE
Active Ingredient Strength1 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
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 14537-828-35

24 BAG in 1 CARTON (14537-828-35) > 350 mL in 1 BAG
Marketing Start Date2002-05-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 14537-828-35 [14537082835]

Additive Formula 3 SOLUTION
Marketing CategoryNDA
Application NumberBN001214
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2002-05-29

Drug Details

Active Ingredients

IngredientStrength
DEXTROSE MONOHYDRATE1.1 g/100mL

OpenFDA Data

SPL SET ID:3a084ab2-354c-4975-a100-dffa8e4724b2
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 "Additive Formula 3" or generic name "Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine"

NDCBrand NameGeneric Name
14537-824Additive Formula 3Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, and Adenine
14537-826Additive Formula 3Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, and Adenine
14537-828Additive Formula 3Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, and Adenine
14537-832Additive Formula 3Dextrose Monohydrate, TRISODIUM CITRATE DIHYDRATE, Sodium Chloride, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, Citric Acid Monohydrate, and Adenine
14537-833Additive Formula 3Dextrose Monohydrate, TRISODIUM CITRATE DIHYDRATE, Sodium Chloride, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, Citric Acid Monohydrate, and Adenine
14537-834Additive Formula 3Dextrose Monohydrate, TRISODIUM CITRATE DIHYDRATE, Sodium Chloride, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, Citric Acid Monohydrate, and Adenine

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