NDC Package 53877-001-14 Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)

Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1) Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
53877-001-14
Package Description:
24 BAG in 1 CASE / 70 mL in 1 BAG
Product Code:
Proprietary Name:
Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)
Non-Proprietary Name:
Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)
Substance Name:
Adenine; Anhydrous Citric Acid; Dextrose Monohydrate; Sodium Phosphate, Monobasic, Monohydrate; Trisodium Citrate Dihydrate
Usage Information:
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.
11-Digit NDC Billing Format:
53877000114
Product Type:
Human Prescription Drug
Labeler Name:
Terumo Corporation
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):
  • 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.
  • Sample Package:
    No
    FDA Application Number:
    BN820528
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    05-22-2012
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    53877-001-0130 BAG in 1 CASE / 35 mL in 1 BAG
    53877-001-0230 BAG in 1 CASE / 63 mL in 1 BAG
    53877-001-0360 BAG in 1 CASE / 63 mL in 1 BAG
    53877-001-0448 BAG in 1 CASE / 63 mL in 1 BAG
    53877-001-0530 BAG in 1 CASE / 63 mL in 1 BAG
    53877-001-0636 BAG in 1 CASE / 70 mL in 1 BAG
    53877-001-0730 BAG in 1 CASE / 70 mL in 1 BAG
    53877-001-0824 BAG in 1 CASE / 70 mL in 1 BAG
    53877-001-0924 BAG in 1 CASE / 63 mL in 1 BAG
    53877-001-1036 BAG in 1 CASE / 63 mL in 1 BAG
    53877-001-1130 BAG in 1 CASE / 63 mL in 1 BAG
    53877-001-1224 BAG in 1 CASE / 63 mL in 1 BAG
    53877-001-1330 BAG in 1 CASE / 70 mL in 1 BAG

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 53877-001-14?

    The NDC Packaged Code 53877-001-14 is assigned to a package of 24 bag in 1 case / 70 ml in 1 bag of Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1), a human prescription drug labeled by Terumo Corporation. The product's dosage form is solution and is administered via intravenous form.

    Is NDC 53877-001 included in the NDC Directory?

    Yes, Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1) with product code 53877-001 is active and included in the NDC Directory. The product was first marketed by Terumo Corporation on May 22, 2012 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 53877-001-14?

    The 11-digit format is 53877000114. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-253877-001-145-4-253877-0001-14