Home NDC 53877-101 TERUFLEX Blood with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative for Collection of 450mL of Blood
Product NDC 53877-101
11-digit product format 538770101
Labeler code 53877
Product ID 53877-101_ca19d052-4e15-47ae-93b6-10cd8d56861c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dextrose monohydrate, trisodium citrate dihydrate, anhydrous citric acid, sodium phosphate, monobasic, unspecified form, sodium chloride, mannitol, and adenine
Dosage form KIT
Route INTRAVENOUS
Labeler Terumo Corporation
Application BN880217
Marketing category NDA
Marketing start 2010-05-05
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 with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative for Collection of 450mL of Blood
Listing expiration 2026-12-31 DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53877-101-01 TERUFLEX Blood with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative for Collection of 450mL of Blood 4 in 1 BLISTER PACK KIT 4 1 53877-101-02 TERUFLEX Blood with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative for Collection of 450mL of Blood 1 in 1 BAG KIT 1 1 53877-101-06 TERUFLEX Blood with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative for Collection of 450mL of Blood 6 in 1 CASE KIT 6 1 53877-111-63 TERUFLEX Blood with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative for Collection of 450mL of Blood 63 mL in 1 BAG SOLUTION 63 mL 25.5 g in 1000mL 1 53877-121-10 TERUFLEX Blood with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative for Collection of 450mL of Blood 100 mL in 1 BAG SOLUTION 100 mL 900 mg in 100mL 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53877-101 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) KIT [TERUMO CORPORATION] 1 Current NDC, 5 package rows 20241020_24057196-619a-4218-8e30-35388daee92f.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 53877-101-01 53877010101 4 in 1 BLISTER PACK Historical 53877-101-02 53877010102 1 in 1 BAG Historical 53877-101-06 53877010106 6 BLISTER PACK in 1 CASE (53877-101-06) / 4 BAG in 1 BLISTER PACK (53877-101-01) / 1 KIT in 1 BAG (53877-101-02) * 63 mL in 1 BAG (53877-111-63) * 100 mL in 1 BAG (53877-121-10) 6 blister pack 2010-05-05 No No Current 53877-111-63 53877011163 63 mL in 1 BAG 63 ml Historical 53877-121-10 53877012110 100 mL in 1 BAG 100 ml Historical