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  4. NDC Product Code: 53877-001 Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)

NDC 53877-001 Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)

Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1) Solution Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 53877-001?
  4. Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1) Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

NDC Product Code:
53877-001
Proprietary Name:
Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)
Non-Proprietary Name: [1]
Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)
Substance Name: [2]
Adenine; Anhydrous Citric Acid; Dextrose Monohydrate; Sodium Phosphate, Monobasic, Monohydrate; Trisodium Citrate Dihydrate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
    • Labeler Name: [5]
    Terumo Corporation
    Labeler Code:
    53877
    Product Label ID:
    123381eb-3b2a-4a9e-9ee7-f9d7aa7b8979
    FDA Application Number: [6]
    BN820528
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    05-22-2012
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 53877-001?

    The NDC code 53877-001 is assigned by the FDA to the product Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1) which is a human prescription drug product labeled by Terumo Corporation. The generic name of Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1) is anticoagulant citrate phosphate dextrose adenine (cpda-1). The product's dosage form is solution and is administered via intravenous form. The product is distributed in 14 packages with assigned NDC codes 53877-001-01 30 bag in 1 case / 35 ml in 1 bag, 53877-001-02 30 bag in 1 case / 63 ml in 1 bag, 53877-001-03 60 bag in 1 case / 63 ml in 1 bag, 53877-001-04 48 bag in 1 case / 63 ml in 1 bag, 53877-001-05 30 bag in 1 case / 63 ml in 1 bag, 53877-001-06 36 bag in 1 case / 70 ml in 1 bag, 53877-001-07 30 bag in 1 case / 70 ml in 1 bag, 53877-001-08 24 bag in 1 case / 70 ml in 1 bag, 53877-001-09 24 bag in 1 case / 63 ml in 1 bag, 53877-001-10 36 bag in 1 case / 63 ml in 1 bag, 53877-001-11 30 bag in 1 case / 63 ml in 1 bag, 53877-001-12 24 bag in 1 case / 63 ml in 1 bag, 53877-001-13 30 bag in 1 case / 70 ml in 1 bag, 53877-001-14 24 bag in 1 case / 70 ml in 1 bag. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)?

    Issued 2011-11 N-BB-CA-A-DB(2)BB89X404+2TERUFLEX BLOOD BAG SYSTEM with Diversion Blood Sampling ArmCPDA-1 SOLUTIONFor the collection of 450 mL and 500 mL of Whole BloodFULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 8, 9, 10, 12, 13, 14, 15 and 17].1.    INDICATIONS AND USAGE1.1.   Read these instructions carefully before use.1.2.   Rx ONLY1.3.   Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4.   For the collection of 450 mL +/- 10% and 500 mL +/- 10% Whole Blood.1.5.   Integral Diversion Blood Sampling Arm is intended to divert and obtain donor samples for laboratory testing prior to collection of the whole blood unit.1.6.   For further processing, use standard component processing techniques.

    What are Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1) Active Ingredients?

    An 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.

    Which are Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1) UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1) Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    Which are the Pharmacologic Classes for Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An 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.

    [3] What kind of product is this? - Indicates 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This 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.

    [8] What is the Marketing Category? - Product 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".