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

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Get all the details for National Drug Code (NDC) 53877-001 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
53877-001
Proprietary Name:
Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Labeler Code:
53877
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]
I
Code Navigator:

Code Structure Chart

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 product labeled by Terumo Corporation. The product's dosage form is . 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.

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:

* Please review the disclaimer below.

Product Footnotes

[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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".