53877-108 NDC - TERUFLEX BLOOD ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) FOR COLLECTION OF 450ML OF BLOOD (ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINE)

Drug Information

  • Product NDC: 53877-108
  • Proprietary Name: TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of Blood
  • Non Proprietary Name: Anhydrous Citric Acid, Trisodium Citrate Dihydrate, Sodium Phosphate, Monobasic, Monohydrate, Dextrose Monohydrate, and Adenine
  • Active Ingredient(s): .275 g/1000mL ADENINE; 2.99 g/1000mL ANHYDROUS CITRIC ACID; 31.9 g/1000mL DEXTROSE MONOHYDRATE; 2.22 g/1000mL SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; 26.3 g/1000mL TRISODIUM CITRATE DIHYDRATE
  • Administration Route(s): INTRAVENOUS
  • Dosage Form(s): SOLUTION
  • Pharmacy Class(es): Acidifying Activity [MoA]; Acidifying Activity [MoA]; Anti-coagulant [EPC]; Anti-coagulant [EPC]; Calcium Chelating Activity [MoA]; Calcium Chelating Activity [MoA]; Calculi Dissolution Agent [EPC]; Calculi Dissolution Agent [EPC]; Decreased Coagulation Factor Activity [PE]; Decreased Coagulation Factor Activity [PE]

Labeler Information

Field Name Field Value
Labeler Name: Terumo Corporation
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: BN820528
Marketing Category: NDA
Start Marketing Date:12/14/2009

Package Information

No. Package Code Package Description Billing Unit
153877-108-066 BLISTER PACK in 1 CASE (53877-108-06) / 4 BAG in 1 BLISTER PACK (53877-108-01) / 63 mL in 1 BAG (53877-108-02)

NDC Record

Field Name Field Value Definition
PRODUCT NDC53877-108The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMETERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of BloodThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAnhydrous Citric Acid, Trisodium Citrate Dihydrate, Sodium Phosphate, Monobasic, Monohydrate, Dextrose Monohydrate, and AdenineThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRAVENOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE12/14/2009This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERBN820528This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMETerumo CorporationName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH.275; 2.99; 31.9; 2.22; 26.3 
ACTIVE INGRED UNITg/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL 
PHARM CLASSESAcidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE] 

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This page was last updated on: 11/21/2025

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