teruflex blood bag system with diversion blood sampling arm 70 ml cpda-1

Generic: anhydrous citric acid, trisodium citrate dihydrate, sodium phosphate, monobasic, monohydrate, dextrose monohydrate, 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 70 ml cpda-1
Generic Name anhydrous citric acid, trisodium citrate dihydrate, sodium phosphate, monobasic, monohydrate, dextrose monohydrate, and adenine
Labeler terumo corporation
Dosage Form SOLUTION
Routes
INTRAVENOUS
Active Ingredients

adenine .275 g/1000mL, anhydrous citric acid 2.99 g/1000mL, dextrose monohydrate 31.9 g/1000mL, sodium phosphate, monobasic, monohydrate 2.22 g/1000mL, trisodium citrate dihydrate 26.3 g/1000mL

Manufacturer
Terumo Corporation

Identifiers & Regulatory

Product NDC 53877-110
Product ID 53877-110_f4ad452e-9aff-4985-a0e4-f8ca3d3cc6c1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number BN820528
Listing Expiration 2026-12-31
Marketing Start 2012-05-22

Pharmacologic Class

Established (EPC)
calculi dissolution agent [epc] anti-coagulant [epc]
Mechanism of Action
acidifying activity [moa] calcium chelating activity [moa]
Physiologic Effect
decreased coagulation factor activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53877110
Hyphenated Format 53877-110

Supplemental Identifiers

UNII
JAC85A2161 XF417D3PSL LX22YL083G 593YOG76RN B22547B95K
NUI
N0000175833 N0000175835 N0000175980 N0000008556 N0000175089

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 70 ml cpda-1 (source: ndc)
Generic Name anhydrous citric acid, trisodium citrate dihydrate, sodium phosphate, monobasic, monohydrate, dextrose monohydrate, and adenine (source: ndc)
Application Number BN820528 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .275 g/1000mL
  • 2.99 g/1000mL
  • 31.9 g/1000mL
  • 2.22 g/1000mL
  • 26.3 g/1000mL
source: ndc
Packaging
  • 6 BLISTER PACK in 1 CASE (53877-110-06) / 5 BAG in 1 BLISTER PACK (53877-110-01) / 70 mL in 1 BAG (53877-110-02)
source: ndc

Packages (1)

53877-110-06 6 BLISTER PACK in 1 CASE (53877-110-06) / 5 BAG in 1 BLISTER PACK (53877-110-01) / 70 mL in 1 BAG (53877-110-02)

Ingredients (5)

adenine (.275 g/1000mL) anhydrous citric acid (2.99 g/1000mL) dextrose monohydrate (31.9 g/1000mL) sodium phosphate, monobasic, monohydrate (2.22 g/1000mL) trisodium citrate dihydrate (26.3 g/1000mL)

Linked Drug Pages (1)

teruflex blood bag system with diversion blood sampling arm 70 ml cpda-1 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "f4ad452e-9aff-4985-a0e4-f8ca3d3cc6c1", "openfda": {"nui": ["N0000175833", "N0000175835", "N0000175980", "N0000008556", "N0000175089"], "unii": ["JAC85A2161", "XF417D3PSL", "LX22YL083G", "593YOG76RN", "B22547B95K"], "spl_set_id": ["86b3a329-c83f-4977-92f5-0e9dfe1872d7"], "pharm_class_pe": ["Decreased Coagulation Factor Activity [PE]"], "pharm_class_epc": ["Calculi Dissolution Agent [EPC]", "Anti-coagulant [EPC]"], "pharm_class_moa": ["Acidifying Activity [MoA]", "Calcium Chelating Activity [MoA]"], "manufacturer_name": ["Terumo Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BLISTER PACK in 1 CASE (53877-110-06)  / 5 BAG in 1 BLISTER PACK (53877-110-01)  / 70 mL in 1 BAG (53877-110-02)", "package_ndc": "53877-110-06", "marketing_start_date": "20120522"}], "brand_name": "teruflex blood bag system with diversion blood sampling arm 70 ml cpda-1", "product_id": "53877-110_f4ad452e-9aff-4985-a0e4-f8ca3d3cc6c1", "dosage_form": "SOLUTION", "pharm_class": ["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]"], "product_ndc": "53877-110", "generic_name": "Anhydrous Citric Acid, Trisodium Citrate Dihydrate, Sodium Phosphate, Monobasic, Monohydrate, Dextrose Monohydrate, and Adenine", "labeler_name": "Terumo Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "teruflex blood bag system with diversion blood sampling arm 70 ml cpda-1", "active_ingredients": [{"name": "ADENINE", "strength": ".275 g/1000mL"}, {"name": "ANHYDROUS CITRIC ACID", "strength": "2.99 g/1000mL"}, {"name": "DEXTROSE MONOHYDRATE", "strength": "31.9 g/1000mL"}, {"name": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE", "strength": "2.22 g/1000mL"}, {"name": "TRISODIUM CITRATE DIHYDRATE", "strength": "26.3 g/1000mL"}], "application_number": "BN820528", "marketing_category": "NDA", "marketing_start_date": "20120522", "listing_expiration_date": "20261231"}