Home NDC 53877-108 TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of Blood
Product NDC 53877-108
11-digit product format 538770108
Labeler code 53877
Product ID 53877-108_1c357037-16d2-4bd1-9100-611326e8a468
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Anhydrous Citric Acid, Trisodium Citrate Dihydrate, Sodium Phosphate, Monobasic, Monohydrate, Dextrose Monohydrate, and Adenine
Dosage form SOLUTION
Route INTRAVENOUS
Labeler Terumo Corporation
Application BN820528
Marketing category NDA
Marketing start 2009-12-14
Substance ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE
Active strength .275; 2.99; 31.9; 2.22; 26.3 g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL
Pharmacologic classes Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of Blood
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ANHYDROUS CITRIC ACID .275 g/1000mL TRISODIUM CITRATE DIHYDRATE 2.99 g/1000mL SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 31.9 g/1000mL DEXTROSE MONOHYDRATE 2.22 g/1000mL ADENINE 26.3 g/1000mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53877-108-01 TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of Blood 4 in 1 BLISTER PACK SOLUTION 4 1 53877-108-02 TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of Blood 63 mL in 1 BAG SOLUTION 63 1 53877-108-06 TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of Blood 6 in 1 CASE SOLUTION 6 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53877-108 TERUFLEX BLOOD ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) FOR COLLECTION OF 450ML OF BLOOD (ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINE) SOLUTION [TERUMO CORPORATION] 1 Current NDC, 3 package rows 20240921_02015040-9b71-4dbe-8f8d-e0d0951e8f93.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join teruflex blood bag system with diversion blood sampling arm 70 ml cpda-1 ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINE Terumo Corporation 86b3a329-c83f-4977-92f5-0e9dfe1872d7 2024-10-10 Warnings Exact identifier application number: BN820528 TERUFLEX BLOOD with Diversion Blood Sampling Arm 70 mL CPDA-1 ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINE Terumo Corporation 39f2e11c-5a31-469f-b725-d096c1674421 2024-10-03 Warnings Exact identifier application number: BN820528 TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of Blood ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINE Terumo Corporation 02015040-9b71-4dbe-8f8d-e0d0951e8f93 2024-09-19 Warnings Exact identifier application number: BN820528 ndc (product): 53877-108
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 53877-108-01 53877010801 4 in 1 BLISTER PACK Historical 53877-108-02 53877010802 63 mL in 1 BAG 63 ml Historical 53877-108-06 53877010806 6 BLISTER PACK in 1 CASE (53877-108-06) / 4 BAG in 1 BLISTER PACK (53877-108-01) / 63 mL in 1 BAG (53877-108-02) 6 blister pack 2009-12-14 No No Current