NDC 53877-0110-06 — teruflex blood bag system with diversion

🆔 Identity & classification

FDA NDC (as labeled) 53877-110-06

Product NDC 53877-110

11-digit billing NDC 53877011006

UNII XF417D3PSL, B22547B95K, 593YOG76RN, LX22YL083G, JAC85A2161

Application # BN820528

SPL Set ID 86b3a329-c83f-4977-92f5-0e9dfe1872d7

Established class (EPC) Calculi Dissolution Agent; Anti-coagulant

Mechanism of action Acidifying Activity; Calcium Chelating Activity

Physiologic effect Decreased Coagulation Factor Activity

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2012-05-22

Route INTRAVENOUS

Dosage form SOLUTION

Substance ANHYDROUS CITRIC ACID; TRISODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; DEXTROSE MONOHYDRATE; ADENINE

Why two NDCs? The FDA registers this code as 53877-110-06 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 53877-0110-06. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerTerumo Corporation

FDA applicationBN820528 (NDA)

Labeler code53877

First marketedMay 2012

Product typeHuman Prescription Drug

Portfolio12 products on file

🔎 All NDCs from Terumo Corporation

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist

No — CPDA-1 is not a drug you take yourself. It's the anticoagulant preservative solution inside a blood collection bag used at blood banks and donation centers. Trained healthcare...
Is this something a patient takes as a medication?
Each ingredient plays a role in keeping donated blood usable. Citrate (from citric acid) prevents clotting. Dextrose (a sugar) gives red blood cells energy to stay alive during sto...
Why does the blood bag contain all those ingredients — citric acid, dextrose, adenine, and phosphate?

📖 Read our full Adenine / Anhydrous Citric Acid / Dextrose / Monobasic / Monohydrate / Sodium Phosphate / Trisodium guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

1 inactive ingredient listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
teruflex blood bag system with diversion blood sampling arm 70 ml cpda-1 2.99 g/1000mL; 26.3 g/1000mL; 2.22 g/1000mL; 31.9 g/1000mL; .275 g/1000mLthis 53877-0110-06	Terumo	70 ml	—	—	FDA listed	—
TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of Blood 2.99 g/1000mL; 26.3 g/1000mL; 2.22 g/1000mL; 31.9 g/1000mL; .275 g/1000mL 53877-0108-06	Terumo	63 ml	—	—	FDA listed	—
TERUFLEX BLOOD with Diversion Blood Sampling Arm 70 mL CPDA-1 2.99 g/1000mL; 26.3 g/1000mL; 2.22 g/1000mL; 31.9 g/1000mL; .275 g/1000mL 53877-0109-06	Terumo	70 ml	—	—	FDA listed	—

About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2012

On the market since

May 2012

📍

2026

Currently FDA-listed

14 years listed

🔒

·

No generic listed yet

brand only

ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
53877-0110-06 You're viewing this	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)	2012-05-22	Active

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 53877-110-06, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 53877-0110-06, written without dashes as 53877011006. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 53877-0110-06, the first segment (53877) is the labeler code FDA assigned to Terumo Corporation; the middle segment (0110) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Terumo Corporation. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Terumo Corporation is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⚠️ Warnings and Cautions 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description

🎯 Indications and Usage 82 words ▾

1. INDICATIONS AND USAGE 1.1. Read these instructions carefully before use.

1.2. Rx ONLY. 1.3.

Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion. 1.4.

For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood. 1.5. Integral Diversion Blood Sampling Arm is intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit.

1.6. For further processing, use standard component processing techniques.

⏱️ Dosage and Administration ~3 min read ▾

2. DOSAGE AND ADMINISTRATION 2.1. To open blister package, peel cover film back 4/5 of its length.

2.2. Prepare the blood bag following your institution's standard operating procedures. 2.2.1.

Materials Needed: VENOJECT II Tube Holder (code P-1316R) or equivalent VENOJECT II Multi-Sample Luer Adapter (code MN*2000T) or equivalent Evacuated blood collection tubes (glass or plastic) 2.3. Make a loose knot in the donor tubing below the "Y" and CLIKTIP (inline closure device) unless alternate methods are used to seal the tubing at the end of collection. 2.4.

Temporarily clamp donor tubing between the phlebotomy needle and the "Y". 2.5. Close the White Clamp below the diversion pouch.

2.6. Assemble the luer adapter and the tube holder. 2.6.1.

Connect the VENOJECT II Multi-Sample Luer Adapter to the VENOJECT II Tube Holder (or equivalent) (Fig. 1). 2.6.2.

Twist and snap to remove the blue port cap at the end of the Diversion Blood Sampling Arm (Fig. 2a). 2.6.3.

Insert the Holder/Luer assembly in the female luer port (Fig. 2b). 2.6.4.

NOTE: Alternatively, steps 2.6.1., 2.6.2., and 2.6.3. (above) may be performed at any time during bag preparation or after the blood is collected into the diversion pouch. 2.7.

Suspend the collection bag as far as possible below the donor's arm. 2.8. Apply blood pressure cuff or tourniquet to donor's arm.

Disinfect site of phlebotomy according to institutional standard operating procedures. If blood pressure cuff is used, inflate to approximately 60 mmHg. 2.9.

Remove the needle cover and perform phlebotomy. Remove the temporary clamp on the donor tubing to permit blood flow into the Diversion Blood Sampling Arm pouch. 2.9.1.

CAUTION: Do not touch the needle after removing the needle cover. 2.9.2. CAUTION: Assure that the White Clamp below the pouch is closed prior to initiating phlebotomy.

2.10. Secure the needle safety device in place following the device instructions provided on the reverse side. 2.11.

Secure donor tubing to donor's arm. 2.12. Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly (or port cap) down.

When the level of blood in the pouch is approximately in line with the notches, the diversion pouch is full (Fig. 3a). 2.12.1.

NOTE: The approximate fill volume of the pouch at the notches is 35 mL. 2.13. Permanently seal the tubing between the "Y" and the diversion pouch to maintain a closed system using an aluminum clip or a tube sealer approved for use with tubing connected to a donor (Fig.

3b). 2.13.1. CAUTION: Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose.

2.14. To initiate blood flow into the collection bag, break the CLIKTIP between the "Y" and the collection bag. 2.15.

To avoid clot formation, collect samples as soon as possible from the diversion pouch as follows (Fig. 3b). 2.15.1.

CAUTION: Do not collect donor test samples until the tubing between the "Y" and the diversion pouch is permanently sealed. 2.15.2. Open the White Clamp on the tubing below the pouch to open the pathway for sampling.

2.15.3. Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly downward. Assure that any air in the pouch is at the top and will not enter the blood collection tubes.

2.15.4. Insert blood collection tube firmly into the tube holder; when full, remove sample tube from holder. Repeat to collect additional samples.

2.15.5. NOTE: The pouch may be removed after the donor test samples are collected. A second seal must be made between the diversion pouch and the permanent seal prior to removing the pouch.

2.16. Mix blood with anticoagulant in the collection bag and continue to mix at several intervals during collection and immediately after collection. If using an automated mixer, follow manufacturer's instructions.

2.17. Collect labeled volume of blood 450 mL ±10% or 500 mL ±10%. 2.18.

When the desired amount of blood has been…

💊 Dosage Forms and Strengths 105 words ▾

3. DOSAGE FORMS AND STRENGTHS 3.1. 63 mL Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant USP for collection of 450 mL Whole Blood.

Each 63 mL contains 188 mg Citric Acid (anhydrous) USP, 1.66 g Sodium Citrate (dihydrate) USP, 140 mg Monobasic Sodium Phosphate (monohydrate) USP, 2.01 g Dextrose (monohydrate) USP and 17.3 mg Adenine USP. 3.2. 70 mL Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant USP for collection of 500 mL Whole Blood.

Each 70 mL contains 209 mg Citric Acid (anhydrous) USP, 1.84 g Sodium Citrate (dihydrate) USP, 155 mg Monobasic Sodium Phosphate (monohydrate) USP, 2.23 g Dextrose (monohydrate) USP and 19.3 mg Adenine USP.

⚠️ Warnings and Cautions ~1 min read ▾

5. WARNINGS AND PRECAUTIONS 5.1. Rx ONLY.

5.2. Do not use unless solutions are clear and free from particulates. 5.3.

Always inspect the blood bag set for leaks before use. 5.4. Avoid excessive heat and direct sunlight.

Protect from freezing. 5.5. Recommended storage conditions: Room Temperature (15-30°C/59-86°F).

5.6. It is normal to have condensation in the blister packaging. If the amount of moisture is greater than expected, check for leaks from the fluid-filled components of the blood bag set.

5.7. Use aseptic techniques. 5.8.

Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose. 5.9. Do not touch needle after removing the needle cover.

5.10. Assure that the White Clamp below the pouch is closed prior to initiating phlebotomy. 5.11.

Do not collect donor test samples until the tubing between the "Y" and the diversion pouch is permanently sealed. 5.12. Discard the Diversion Blood Sampling Arm and phlebotomy needle/donor tubing according to institutional standard operating procedures.

5.13. The AGELESS oxygen absorber packet, (Mitsubishi Gas Chemical) contained in this package absorbs oxygen and generates heat on removal. Do not open and handle it with care.

5.14. Dispose of the AGELESS packet with the blister tray. 5.15.

Do not dispose the AGELESS packet with wastes containing volatile or flammable materials. 5.16. Due to possible exposure to infectious agents in the handling of blood, take adequate precautions at all times to prevent exposure to and transmission of such agents.

Follow your institution's standard operating procedures.

📦 How Supplied / Storage and Handling ~1 min read ▾

16. HOW SUPPLIED/STORAGE AND HANDLING 16.1. Single use only.

16.2. Sterile and non-pyrogenic fluid path. Sterilized by steam.

Opacity of the blood bag system may be observed. This is due to moisture absorption during the sterilization process. This is normal and does not affect the solution quality or safety.

The opacity will diminish gradually. 16.3. A Material Safety Data Sheet (MSDS) is not required for this product.

16.4. Recommended storage conditions: Room Temperature (15-30°C/59-86°F). 16.5.

Avoid excessive heat and direct sunlight. Protect from freezing. 16.6.

To open blister package, peel cover film back 4/5 of its length. 16.7. After opening the blister package, unused blood bags may be stored at room temperature for 96 hours or they may be stored for 30 days by returning cover film to original position and sealing with tape to prevent evaporation of solutions.

16.8. Blood bags in the unopened blister package may be used through the last day of the month and year as indicated on the original manufacturer's packaging. 16.9.

The AGELESS packet contained in this package absorbs oxygen and generates heat on removal. Do not open and handle it with care. 16.10.

Dispose of the AGELESS packet with the blister tray. 16.11. Do not dispose the AGELESS packet with wastes containing volatile or flammable materials.

16.12. For the Triple blood bag sets, Codes BB * TCD456A2 and BB * TCD506A2 are supplied 30/case. 16.13.

For the Quadruple blood bag sets, Codes BB * QCD456A2 and BB * QCD506A2 are supplied 24/case. MANUFACTURED BY: TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO 151-0072, JAPAN MADE IN JAPAN © TERUMO CORPORATION Mar. 2021 All brand names are trademarks or registered trademarks of TERUMO CORPORATION and their respective owners.

Figure

📦 Storage and Handling 217 words ▾