Home NDC 53877-009-41 TERUFLEX Blood Bag System with Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative
Product NDC 53877-009
Requested package NDC 53877-009-41
11-digit product format 538770009
Labeler code 53877
Product ID 53877-009_89f94557-3a16-4a36-9766-4d03d9defd79
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Anticoagulant Citrate Phosphate Dextrose (CPD) AND AS-5 Red Cell Preservative
Dosage form KIT
Route INTRAVENOUS
Labeler Terumo Corporation
Application BN880217
Marketing category NDA
Marketing start 2010-05-05
Marketing end 0000-00-00
Active strength 0
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53877-009-41 TERUFLEX Blood Bag System with Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative 24 in 1 CASE KIT 24 6 53877-009-41 TERUFLEX Blood Bag System with Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative 1 in 1 BAG KIT 1 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53877-009 TERUFLEX BLOOD BAG SYSTEM WITH BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION] 6 Legacy NDC, 2 package rows 20191217_7a1ce6e8-68fb-4cf0-99a2-f460246a2ba8.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Reveos Select CPD with AS-5 Red Cell Preservative Solution For Collection Of 500ml Of Blood ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE Terumo BCT Vietnam CO., Ltd. 58bdabc8-283a-47bd-8abe-dd9284f3f497 2025-01-14 Warnings, Adverse reactions Exact identifier application number: BN880217 IMUFLEX WB-SP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Saving Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) and OPTISOL (AS-5) Red Cell Preservative for collection of 500mL of Blood ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE Terumo Corporation ebaeef7d-abb9-4327-bb34-18d146a07376 2024-12-17 Warnings Exact identifier application number: BN880217 TERUFLEX Blood with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative for Collection of 450mL of Blood DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, ANHYDROUS CITRIC ACID, SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM, SODIUM CHLORIDE, MANNITOL, AND ADENINE Terumo Corporation 24057196-619a-4218-8e30-35388daee92f 2024-10-10 Warnings Exact identifier application number: BN880217 TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative Solution for Collection of 500mL of Blood DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, ANHYDROUS CITRIC ACID, SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM, ANHYDROUS DEXTROSE, SODIUM CHLORIDE, MANNITOL, AND ADENINE Terumo Corporation 5b8b3dbb-b57b-4706-a7aa-daa173caffa2 2024-10-07 Warnings Exact identifier application number: BN880217 IMUFLEX WB-RP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Removing Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE Terumo Corporation 8b22a4c8-2d6e-45d5-82e2-02ef0b713095 2024-08-27 Warnings Exact identifier application number: BN880217
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53877-009-41 53877000941 24 BAG in 1 CASE (53877-009-41) > 1 KIT in 1 BAG * 70 mL in 1 BAG * 111 mL in 1 BAG 24 bag 2010-05-05 0000-00-00 No No Current