teruflex blood bag system with diversion blood sampling arm anticoagulant cpd with optisol red cell preservative solution for collection of 500ml of blood

Generic: dextrose monohydrate, trisodium citrate dihydrate, anhydrous citric acid, sodium phosphate, monobasic, unspecified form, anhydrous dextrose, sodium chloride, mannitol, and adenine

Labeler: terumo corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name teruflex blood bag system with diversion blood sampling arm anticoagulant cpd with optisol red cell preservative solution for collection of 500ml of blood
Generic Name dextrose monohydrate, trisodium citrate dihydrate, anhydrous citric acid, sodium phosphate, monobasic, unspecified form, anhydrous dextrose, sodium chloride, mannitol, and adenine
Labeler terumo corporation
Dosage Form KIT
Manufacturer
Terumo Corporation

Identifiers & Regulatory

Product NDC 53877-103
Product ID 53877-103_5bc18ac1-9c3b-4005-bbf6-3b3ee0301f38
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number BN880217
Listing Expiration 2026-12-31
Marketing Start 2010-05-05

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53877103
Hyphenated Format 53877-103

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name teruflex blood bag system with diversion blood sampling arm anticoagulant cpd with optisol red cell preservative solution for collection of 500ml of blood (source: ndc)
Generic Name dextrose monohydrate, trisodium citrate dihydrate, anhydrous citric acid, sodium phosphate, monobasic, unspecified form, anhydrous dextrose, sodium chloride, mannitol, and adenine (source: ndc)
Application Number BN880217 (source: ndc)

Resolved Composition

Strengths
  • 63 ml
  • 450 ml
  • 1.61 g
  • 1.66 g
  • 188 mg
  • 140 mg
  • 70 ml
  • 500 ml
  • 1.79 g
  • 1.84 g
  • 209 mg
  • 156 mg
  • 100 ml
  • 877 mg
  • 900 mg
  • 525 mg
  • 30 mg
  • 111 ml
  • 974 mg
  • 1.00 g
  • 583 mg
  • 33.3 mg
source: label
Packaging
  • 6 BLISTER PACK in 1 CASE (53877-103-06) / 4 BAG in 1 BLISTER PACK (53877-103-01) / 1 KIT in 1 BAG (53877-103-02) * 70 mL in 1 BAG (53877-111-70) * 111 mL in 1 BAG (53877-121-11)
source: ndc

Packages (1)

53877-103-06 6 BLISTER PACK in 1 CASE (53877-103-06) / 4 BAG in 1 BLISTER PACK (53877-103-01) / 1 KIT in 1 BAG (53877-103-02) * 70 mL in 1 BAG (53877-111-70) * 111 mL in 1 BAG (53877-121-11)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative Solution for Collection of 500mL of Blood ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "5bc18ac1-9c3b-4005-bbf6-3b3ee0301f38", "openfda": {"spl_set_id": ["5b8b3dbb-b57b-4706-a7aa-daa173caffa2"], "manufacturer_name": ["Terumo Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BLISTER PACK in 1 CASE (53877-103-06)  / 4 BAG in 1 BLISTER PACK (53877-103-01)  / 1 KIT in 1 BAG (53877-103-02)  *  70 mL in 1 BAG (53877-111-70)  *  111 mL in 1 BAG (53877-121-11)", "package_ndc": "53877-103-06", "marketing_start_date": "20100505"}], "brand_name": "TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative Solution for Collection of 500mL of Blood", "product_id": "53877-103_5bc18ac1-9c3b-4005-bbf6-3b3ee0301f38", "dosage_form": "KIT", "product_ndc": "53877-103", "generic_name": "Dextrose Monohydrate, Trisodium Citrate Dihydrate, Anhydrous Citric Acid, Sodium Phosphate, Monobasic, Unspecified Form, Anhydrous Dextrose, Sodium Chloride, Mannitol, and Adenine", "labeler_name": "Terumo Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative Solution for Collection of 500mL of Blood", "application_number": "BN880217", "marketing_category": "NDA", "marketing_start_date": "20100505", "listing_expiration_date": "20261231"}