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TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative Solution for Collection of 500mL of Blood Dextrose Monohydrate, Trisodium Citrate Dihydrate, Anhydrous Citric Acid, Sodium Phosphate, Monobasic, Unspecified Form, Anhydrous Dextrose, Sodium Chloride, Mannitol, and Adenine Kit — NDC 53877-103-06 (Billing 53877-0103-06)

by Terumo Corporation · 6 BLISTER PACK in 1 CASE / 4 BAG in 1 BLISTER PACK / 1 KIT in 1 BAG * 70 mL in 1 BAG * 111 mL in 1 BAG

This is a package of TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative Solution for Collection of 500mL of Blood Dextrose Monohydrate, Trisodium Citrate Dihydrate, Anhydrous Citric Acid, Sodium Phosphate, Monobasic, Unspecified Form, Anhydrous Dextrose, Sodium Chloride, Mannitol, and Adenine Kit from Terumo Corporation, marketed since May 2010 and currently FDA-listed. It is this product's only package size.

NDC 53877-0103-06
🏷️ FDA NDC (as labeled) 53877-103-06 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 53877-103-06 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
53877 labeler · 103 product · 06 package
Package marketed since
May 5, 2010
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5387710306 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 53877-103-06
Product NDC 53877-103
11-digit billing NDC 53877010306
Application # BN880217
SPL Set ID 5b8b3dbb-b57b-4706-a7aa-daa173caffa2
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-05-05
Dosage form KIT
Why two NDCs? The FDA registers this code as 53877-103-06 — 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 → 53877-0103-06. 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.

Clinical

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.

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 systemPer eachPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
53877-0103-06 You're viewing this Main listing 6 BLISTER PACK in 1 CASE / 4 BAG in 1 BLISTER PACK / 1 KIT in 1 BAG * 70 mL in 1 BAG * 111 mL in 1 BAG 2010-05-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative Solution for Collection of 500mL of Bloodthis 53877-0103-06 Terumo 1 kit — — 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

🏛️
2010
On the market since
May 2010
📍
2026
Currently FDA-listed
16 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.

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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

Manufacturer & labeler

LabelerTerumo Corporation
FDA applicationBN880217 (NDA)
Labeler code53877
First marketedMay 2010
Product typeHuman Prescription Drug
Portfolio12 products on file

More NDCs from Terumo Corporation labeler code 53877

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⚠️ Warnings 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 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. 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 guard 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 collected, seal the tubing or tighten the loose knot (whit… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 152 words ▾

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

Each 63 mL contains 1.61 g Dextrose (monohydrate) USP, 1.66 g Sodium Citrate (dihydrate) USP, 188 mg Citric Acid (anhydrous) USP, 140 mg Monobasic Sodium Phosphate (monohydrate) USP. 3.2. 70 mL Citrate Phosphate Dextrose (CPD) anticoagulant USP for collection of 500 mL Whole Blood.

Each 70 mL contains 1.79 g Dextrose (monohydrate) USP, 1.84 g Sodium Citrate (dihydrate) USP, 209 mg Citric Acid (anhydrous) USP, 156 mg Monobasic Sodium Phosphate (monohydrate) USP. 3.3. 100 mL OPTISOL Red Cell Preservative Solution.

Each 100 mL contains 877 mg Sodium Chloride USP, 900 mg Dextrose (monohydrate) USP, 525 mg Mannitol USP, 30 mg Adenine USP. 3.4. 111 mL OPTISOL Red Cell Preservative Solution.

Each 111 mL contains 974 mg Sodium Chloride USP, 1.00g Dextrose (monohydrate) USP, 583 mg Mannitol USP, 33.3 mg Adenine USP.

⚠️ Warnings ~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 Double blood bag sets, Codes BB * AGD456A2 and BB * AGD506A2 are supplied 24/case. 16.13.

For the Triple blood bag sets, Codes BB * AGT456A2 and BB * AGT506A2 are supplied 24/case. 16.14. For the Quadruple blood bag sets, Codes BB * AGQ456A2 and BB * AGQ506A2 are supplied 18/case.

Figure

📦 Storage and Handling 201 words ▾

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 Double blood bag sets, Codes BB * AGD456A2 and BB * AGD506A2 are supplied 24/case. 16.13.

For the Triple blood bag sets, Codes BB * AGT456A2 and BB * AGT506A2 are supplied 24/case. 16.14. For the Quadruple blood bag sets, Codes BB * AGQ456A2 and BB * AGQ506A2 are supplied 18/case.

Figure

📋 Description ~1 min read ▾

11. DESCRIPTION / PRODUCT SPECIFICATIONS 11.1. This blood bag system includes a 16 gauge × 1 1/2 inch (1.60 × 38 mm) needle with needle cover and either a 450mL or 500mL (nominal capacity 600mL) primary collection bag containing 63 mL or 70mL, respectively, Citrate Phosphate Dextrose (CPD) anticoagulant.

The Double blood bag set has one integrally attached empty satellite bag and one satellite bag containing 100 mL or 111 mL, respectively, OPTISOL Red Cell Preservative Solution. The Triple blood bag set has one empty XT-612 5 day Platelet bag and one satellite bag containing 100 mL or 111 mL, respectively, OPTISOL Red Cell Preservative Solution. The Quadruple blood bag set has one integrally attached empty XT-612 5 day Platelet bag, one empty satellite bag, and one satellite bag containing 100 mL or 111 mL, respectively, OPTISOL Red Cell Preservative Solution.

11.2. Blood bag codes ending in A2 are supplied with Integral Diversion Blood Sampling Arm intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 11.3.

Blood bag codes ending in A2 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4.

The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex.

11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7.

Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available.

📄 Patient Package Insert ~2 min read ▾

PROCEDURE FOR USE OF DonorCare™ Needle Guard This device is for use by trained individuals. Intended Use The DonorCare Needle Guard is incorporated onto the donor tubing to shield the needle immediately after withdrawal from the donor. Single Use Only.

Preparation 1. Move the DonorCare on the tubing ensuring that it slides easily and the arrow is pointing toward the needle hub. 2.

Ensure that the three lock points on the DonorCare are locked closed. Whole Blood Collection 3. Perform the phlebotomy as per your institution's standard operating procedures.

4. Slide the DonorCare over the needle hub so that it covers approximately one half to two thirds of the needle hub. 5.

Stabilize the DonorCare to the arm by placing a piece of tape over the front end so that the tape does not extend over the front of the DonorCare. Withdrawal of Needle Important The DonorCare must be held stationary while the needle is withdrawn into it. Caution The needle must be fully shielded by DonorCare to prevent accidental injury.

6. Hold gauze over the venipuncture site with finger tips without exerting pressure. Hold the sides of the DonorCare near the front with the index finger and thumb of the same hand.

7. With the other hand, hold the donor tubing close behind the DonorCare. Note: A hemostat may be placed on the tubing behind the DonorCare when the blood collection is complete.

This will help to prevent blood drops from forming. 8. Pull tubing smoothly and swiftly with one motion until the needle is locked in place inside the DonorCare.

9. Confirm that the needle is locked by: Listening for two 'clicks' as the needle is drawn into DonorCare. If the clicks are not heard as the needle is drawn into the DonorCare, continue to pull firmly on the tubing to assure needle is fully withdrawn into DonorCare.

10. Visually check that the needle is fully shielded by DonorCare before removing from the donor's arm. 11.

Remove the tape from the DonorCare and arm. 12. Apply pressure to the gauze covering the venipuncture site.

Warning Do not place fingers at the opening of DonorCare after removal from the donor's arm. Difficult Phlebotomy (Examples may include: Slow blood flow, deep or fine vein, steep angle) It may be necessary to delay placing the DonorCare over the needle hub until the end of the blood collection. In such situations: Leave the DonorCare on the tubing behind the needle hub.

At the end of the blood collection carefully remove the tape from the needle hub and slide the DonorCare over the hub so that it covers approximately one half to two thirds of the needle hub. Withdraw the needle into the DonorCare as stated in steps 6. through 12. above Rx ONLY DonorCare is manufactured by ITL Corporation, Melbourne, Australia. TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO 151-0072, JAPAN © TERUMO CORPORATION Mar.

2021 Figure Figure Figure Figure

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL - Kit Case Label TERUFLEX™ BLOOD BAG SYSTEM with Diversion Blood Sampling Arm™ TERUMO CPD WITH OPTISOL RED CELL PRESERVATIVE SOLUTION FOR COLLECTION OF 500mL OF BLOOD Each unit consists of a primary bag containing 70 mL of Anticoagulant CPD solution, with a satellite bag containing 111 mL of OPTISOL Red Cell Preservative Solution. Each 70 mL Anticoagulant CPD solution USP contains 1.79 g Dextrose (monohydrate) USP, 1.84 g Sodium Citrate (dihydrate) USP, 209 mg Citric Acid (anhydrous) USP, 156 mg Monobasic Sodium Phosphate (monohydrate) USP.

Each 111 mL OPTISOL Red Cell Preservative Solution contains 974 mg Sodium Chloride USP, 1.00 g Dextrose (monohydrate) USP, 583 mg Mannitol USP, 33.3 mg Adenine USP. STERILE, NON-PYROGENIC FLUID PATH. DO NOT USE UNLESS ANTICOAGULANT IS CLEAR.

NDC:53877-103-06 CODE LOT No. EXPIRY DONOR NEEDLE 16G × 1½"(1.60 × 38 mm) 500 UNITS Rx ONLY RECOMMENDED STORAGE : Room Temperature (15-30 °C/ 59-86 °F). Avoid excessive heat.

Protect from freezing. After opening, unused bags may be stored for 30 days by returning cover film to original position and sealing with tape to prevent possible loss of moisture. See Instructions For Blood Collection.

Manufactured by : TERUMO CORPORATION Tokyo, Japan All brand names are trademarks or registered trademarks owned by TERUMO CORPORATION, its affiliates, or unrelated third parties. Rev. 2024-07 SC-4-H6-A2 ① PRINCIPAL DISPLAY PANEL - Kit Case Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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.
← 53877-0101-06 · Terumo 53877-0105-06 · Terumo →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.