53877-001 NDC - TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) ()

Drug Information

  • Product NDC: 53877-001
  • Proprietary Name: TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Terumo Corporation
Product Type:
FDA Application Number: BN820528
Marketing Category: NDA
Start Marketing Date:11/18/2009
End Marketing Date:11/1/2024

Package Information

No. Package Code Package Description Billing Unit
153877-001-0130 BAG in 1 CASE (53877-001-01) / 35 mL in 1 BAG
253877-001-0230 BAG in 1 CASE (53877-001-02) / 63 mL in 1 BAG
353877-001-0360 BAG in 1 CASE (53877-001-03) / 63 mL in 1 BAG
453877-001-0448 BAG in 1 CASE (53877-001-04) / 63 mL in 1 BAG
553877-001-0530 BAG in 1 CASE (53877-001-05) / 63 mL in 1 BAG
653877-001-0636 BAG in 1 CASE (53877-001-06) / 70 mL in 1 BAG
753877-001-0730 BAG in 1 CASE (53877-001-07) / 70 mL in 1 BAG
853877-001-0824 BAG in 1 CASE (53877-001-08) / 70 mL in 1 BAG
953877-001-0924 BAG in 1 CASE (53877-001-09) / 63 mL in 1 BAG
1053877-001-1036 BAG in 1 CASE (53877-001-10) / 63 mL in 1 BAG
1153877-001-1130 BAG in 1 CASE (53877-001-11) / 63 mL in 1 BAG
1253877-001-1224 BAG in 1 CASE (53877-001-12) / 63 mL in 1 BAG
1353877-001-1330 BAG in 1 CASE (53877-001-13) / 70 mL in 1 BAG
1453877-001-1424 BAG in 1 CASE (53877-001-14) / 70 mL in 1 BAG

NDC Record

Field Name Field Value Definition
PRODUCT NDC53877-001The 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.
PROPRIETARY NAMETERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE5/22/2012This 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.
PRODUCT NDC53877-001The 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.
PROPRIETARY NAMETERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
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.
PRODUCT NDC53877-001The 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.
PROPRIETARY NAMETERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE12/10/2009This 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.
PRODUCT NDC53877-001The 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.
PROPRIETARY NAMETERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE11/18/2009This 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.

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