NDC 14537-824

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 ID: 14537-824_3973708b-e5a7-47f5-829c-5e3ae9620dd8
• NDC: 14537-824
• Product Type: Human Prescription Drug
• Proprietary Name: Additive Formula 3
• Generic Name: Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine
• Dosage Form: Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2002-05-29
• Marketing Category: NDA / NDA
• Application Number: BN001214
• Labeler Name: Terumo BCT, Ltd
• Substance Name: DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; CITRIC ACID MONOHYDRATE; ADENINE
• Active Ingredient Strength: 1 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
• Pharm Classes: 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 Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 14537-824-10

6 POUCH in 1 CARTON (14537-824-10) > 6 BAG in 1 POUCH > 100 mL in 1 BAG

• Marketing Start Date: 2002-05-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 14537-824-10 [14537082410]

Additive Formula 3 SOLUTION

• Marketing Category: NDA
• Application Number: BN001214
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2002-05-29

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROSE MONOHYDRATE	1.1 g/100mL

OpenFDA Data

• SPL SET ID: 3a084ab2-354c-4975-a100-dffa8e4724b2
• Manufacturer:
  • Terumo BCT, Ltd
• UNII:
  • 451W47IQ8X
  • LX22YL083G
  • 593YOG76RN
  • 2968PHW8QP
  • JAC85A2161
  • B22547B95K

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"

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