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Reveos Select CPD with AS-5 Red Cell Preservative Solution For Collection Of 500ml Of Blood Anticoagulant Citrate Phosphate Dextrose (CPD) and Kit — NDC 82906-506-16 (Billing 82906-0506-16)

by Terumo BCT Vietnam CO., Ltd. · 16 POUCH in 1 CASE / 2 BAG in 1 POUCH / 70 mL in 1 BAG

This is a package of Reveos Select CPD with AS-5 Red Cell Preservative Solution For Collection Of 500ml Of Blood Anticoagulant Citrate Phosphate Dextrose (CPD) and Kit from Terumo BCT Vietnam CO., Ltd., marketed since Aug 2023 and currently FDA-listed. It is this product's only package size.

NDC 82906-0506-16
🏷️ FDA NDC (as labeled) 82906-506-16 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 82906-506-16 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
82906 labeler · 506 product · 16 package
Package marketed since
Aug 16, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8290650616 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 82906-506-16
Product NDC 82906-506
11-digit billing NDC 82906050616
Application # BN880217
SPL Set ID 58bdabc8-283a-47bd-8abe-dd9284f3f497
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-08-16
Dosage form KIT
Why two NDCs? The FDA registers this code as 82906-506-16 — 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 → 82906-0506-16. 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
82906-0506-16 You're viewing this Main listing 16 POUCH in 1 CASE / 2 BAG in 1 POUCH / 70 mL in 1 BAG 2023-08-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Reveos Select CPD with AS-5 Red Cell Preservative Solution For Collection Of 500ml Of Bloodthis 82906-0506-16 Terumo 16 pouches — — FDA listed —
IMUFLEX WB-SP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Saving Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) and OPTISOL (AS-5) Red Cell Preservative for collection of 500mL of Blo 53877-0105-06 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

🏛️
2023
On the market since
Aug 2023
📍
2026
Currently FDA-listed
3 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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 BCT Vietnam CO., Ltd.
FDA applicationBN880217 (NDA)
Labeler code82906
First marketedAug 2023
Product typeHuman Prescription Drug
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 ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 76 words ▾

1 INDICATIONS AND USAGE The Reveos ® SELECT set is intended to collect a unit of whole blood and to process the whole blood unit on the Reveos Automated Blood Processing System, producing blood components. Rx only. The Reveos ® SELECT set is intended to collect a unit of whole blood and to process the whole blood unit on the Reveos Automated Blood Processing System, producing blood components. ( 1 ) Rx only. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Follow the instructions for collecting blood with the Reveos SELECT set. ( 2 ) Follow the instructions for post-processing and red blood cell leukoreduction with the Reveos SELECT set. ( 2 ) Set Diagram 1 Whole blood bag 7 Sample/diversion bag A, C: Y connector 2 Interim platelet unit (IPU) bag 8 Needle B, G: Blue clamp 3 Plasma bag 9 Needle injury protector (NIP) D, F, H, J: CLIKTIP frangible connector 4 Plasma cryoprecipitate reduced bag 10 Sample tube holder/luer adapter E: White clamp 5 Red blood cell (RBC) bag 11 Cross-connector 6 Residual leukocyte bag 12 RBC leukoreduction filter This document provides blood collection and post-processing instructions specific to the Reveos SELECT set.

For warnings, cautions, and instructions on processing whole blood with the Reveos system, see the Reveos system operator's manual. Note : Refer to the instructions for use provided by the manufacturer of your tubing sealer to ensure that the tubing sealer is appropriate for the tubing on the blood bag set. Note : You must validate the process for producing, storing, and handling Cryoprecipitated Antihemophilic Factor within your institution's standard operating procedure (SOP), including procedures for using the plasma cryoprecipitate reduced bag.

Blood Collection Required Supplies: • Scale and/or blood mixing device • Tubing sealer • Evacuated blood collection tubes 1. If it is part of your institution's SOP, make a loose knot in the collection tubing between white clamp E and the whole blood bag. 2.

Separate the sample/diversion bag from the other bags. 3. Load the bags onto a scale and/or blood mixing device according to your institution's SOP.

Ensure that the whole blood bag and the sample bag are lower than the donor's arm. 4. Close blue clamp B.

5. Apply a blood pressure cuff or a tourniquet to the donor's arm. 6.

Prepare the venipuncture site. 7. Twist the needle cap until the resistance stops and then pull the needle cap straight off.

8. Perform the venipuncture according to your institution's SOP. 9.

Open blue clamp B. 10. Position the sample/diversion bag with blue clamp B at the top and the sample tube holder/luer adapter at the bottom (see Figure 1 ).

Allow the desired volume of whole blood to flow into the sample/diversion bag. The nominal volume of the sample bag is 60 mL. When the volume reaches the marking, approximately 40 mL has been collected.

11. Close blue clamp B. 12.

Break CLIKTIP D to allow the whole blood to flow into the whole blood bag. Bend the CLIKTIP in both directions to ensure that you break it completely. 13.

Seal the sample/diversion tubing as near as possible to Y connector A. Seal the tubing according to your institution's SOP. 14.

Invert the sample/diversion bag and transfer donor blood samples from the sample/diversion bag, using evacuated blood collection tubes. Transfer samples as soon as possible after venipuncture to avoid possible clot formation in the sample/diversion bag. a. Hold the sample/diversion bag and sample tube holder/luer adapter in one hand with blue clamp B positioned at the bottom (see Figure 2 ). b.

Using the other hand, insert a blood collection tube firmly into the sample tube holder/luer adapter. After filling the blood collection tube, remove the tube from the sample tube holder. Repeat the process to take additional samples.

15. Mix the whole blood and the anticoagulant during collection according to your institution's SOP. 16.

Collect the target volume of blood ± 10%, as specified on the whole blood bag label. 17. Close white clamp E and perform one of the following steps: If you made a knot in the collection tubing in step 1, tighten the knot firmly.

If you did not make a knot in step 1, seal the collection tubing near CLIKTIP D. 18. Hold the needle hub and then slide the NIP partially over the needle hub (see Figure 3 ).

19. Gently pull on the tubing to withdraw the needle from the donor's arm and into the NIP until the needle locks securely (s… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 147 words ▾

3 DOSAGE FORMS AND STRENGTHS 70 mL Citrate Phosphate Dextrose (CPD) anticoagulant is a sterile solution in a PVC plasticized with DEHP bag. Each 70 mL of CPD contains: Dextrose (anhydrous) 1.624 g, Trisodium Citrate (dihydrate) 1.841 g, Citric Acid (monohydrate) 0.229 g, Sodium Dihydrogen Phosphate (dihydrate) 0.176 g, and water for injection up to 70 mL. 111 mL Additive Solution 5 (AS-5) red cell preservative solution is a sterile solution in a PVC plasticized with DEHP bag.

Each 111 mL of AS-5 contains: Dextrose (anhydrous) 0.908 g, Sodium Chloride 0.973 g, Mannitol 0.583 g, Adenine 0.035 g, and water for injection up to 111 mL. 70 mL Citrate Phosphate Dextrose (CPD) anticoagulant sterile fluid in a PVC plasticized with DEHP bag. ( 3 ) 111 mL Additive Solution 5 (AS-5) red cell preservative solution sterile fluid in a PVC plasticized with DEHP bag.

( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Single-use product. Do not reuse. This product is intended to be single use only and is not intended to be reused or re-sterilized in any manner.

Terumo Blood and Cell Technologies cannot ensure the functionality or sterility of the product if it is reused or re-sterilized. Reuse of a single-use disposable set may result in: Product performance issues due to loss of product integrity, including but not limited to the following: Fluid leaks Parts that are warped or deformed Plastics that are brittle and discolored Filters that have reduced filtration capabilities Viral infections such as hepatitis or human immunodeficiency virus (HIV) Bacterial infections Cross-contamination Any of these risks could result in serious injury or death.

These risks are shared by product users, donors, patients, and recipients of the end product of the device. Inspect the packaging and the blood bag set prior to use. Do not use the set if any of the following conditions are present: There are tears or holes in the outer aluminum foil packaging or in the individual transparent packaging wrap.

The tubing has severe kinks. The blood bag set is incorrectly assembled. The blood bag set is defective or damaged, or there are any leaks from the fluid-filled components of the set.

Any clamps are closed. The needle cap is not in place. The solutions are cloudy or discolored or contain particulates.

Using the blood bag set under these conditions may result in product contamination or poor performance during collection and/or processing. Note : It is normal to have some condensation in the outer aluminum foil pouch and individual transparent packaging wrap due to sterilization. The blood bag set is no longer sterile if any of the following conditions occur: You disconnect the sample/diversion bag before you seal the sample/diversion tubing.

You remove blood samples before you seal the sample/diversion tubing. The integrity of the set is compromised for any reason. Manage the blood bag set according to your institution's SOP.

Do not process whole blood less than 2 hours after collection. Processing blood too soon after collection may result in incomplete RBC leukoreduction and/or a reduced platelet yield. Residual leukocytes are a by-product of the processing procedure and contain mostly white blood cells (WBC), with some plasma, platelets, and red blood cells (RBC).

Residual leukocytes are not intended for transfusion. Use aseptic technique during blood collection to ensure donor safety and product quality. Do not vent the blood bag set.

Do not reuse. ( 5 ) Inspect the packaging and the blood bag set prior to use. ( 5 ) The blood bag set is no longer sterile under certain conditions.

( 5 ) Do not process whole blood less than 2 hours after collection. ( 5 ) Residual leukocytes are not intended for transfusion. ( 5 ) Use aseptic technique during blood collection to ensure donor safety and product quality.

( 5 ) Do not vent the blood bag set. ( 5 )

🤒 Adverse Reactions 40 words ▾

6. ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Terumo BCT, Inc. at 1-877-339-4228 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. To report SUSPECTED ADVERSE REACTIONS, contact Terumo BCT, Inc. at 1-877-339-4228 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ( 6 )

👥 Use in Specific Populations 39 words ▾

8 USE IN SPECIFIC POPULATIONS The Reveos SELECT set has not been adequately studied in controlled clinical trials with specific populations. The Reveos SELECT set has not been studied in controlled clinical trials with specific populations. ( 8 )

🧬 Clinical Pharmacology 140 words ▾

12 CLINICAL PHARMACOLOGY 12.1. Mechanism of Action CPD Mechanism of Action CITRATE PHOSPHATE DEXTROSE acts as an extracorporeal anticoagulant by binding the free calcium in the blood. Calcium is a necessary co-factor to several steps in the clotting cascade.

The following ingredients are key components of the solution: Citric Acid for pH regulation Sodium Citrate functions as an anticoagulant Dextrose for isotonicity Sodium Dihydrogen Phosphate for pH buffering This solution has no clinical effect in transfused patients. AS-5 Mechanism of Action ADDITIVE SOLUTION FORMULA 5 acts to preserve and extend the shelf life of packed RBC products for later transfusion to patients. The following ingredients are key components of the solution: Dextrose for RBC nutrition Sodium Chloride for isotonicity Mannitol to protect RBC membranes Adenine to support adenosine triphosphate (ATP) levels This solution has no clinical effect in transfused patients.

🧬 Mechanism of Action 137 words ▾

12.1. Mechanism of Action CPD Mechanism of Action CITRATE PHOSPHATE DEXTROSE acts as an extracorporeal anticoagulant by binding the free calcium in the blood. Calcium is a necessary co-factor to several steps in the clotting cascade.

The following ingredients are key components of the solution: Citric Acid for pH regulation Sodium Citrate functions as an anticoagulant Dextrose for isotonicity Sodium Dihydrogen Phosphate for pH buffering This solution has no clinical effect in transfused patients. AS-5 Mechanism of Action ADDITIVE SOLUTION FORMULA 5 acts to preserve and extend the shelf life of packed RBC products for later transfusion to patients. The following ingredients are key components of the solution: Dextrose for RBC nutrition Sodium Chloride for isotonicity Mannitol to protect RBC membranes Adenine to support adenosine triphosphate (ATP) levels This solution has no clinical effect in transfused patients.

📦 How Supplied / Storage and Handling 170 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING The blood bag sets are packaged in outer aluminum foil pouches. Each outer aluminum foil pouch contains 2 blood bag sets. Each case contains 8 outer aluminum foil pouches.

CATALOG NUMBER NDC NUMBER 6FO506A0 Carton: 82906-506-16 Aluminum foil: 82906-506-02 Primary Collect Bag: 82906-506-01 STORAGE Long-term storage temperature: 1 °C to 30 °C Permitted temperature excursions: –20 °C to 1 °C for up to 2 weeks Up to 50 °C for up to 1 week Use blood bag sets within 28 days after you open the outer aluminum foil pouch. To store unused blood bag sets, return them to the outer aluminum foil pouch and reclose the pouch with tape or a clip. Once you open the transparent packing wrap, you must use the blood bag set within 7 days, not exceeding 28 days from when you opened the outer aluminum foil pouch.

Each outer aluminum foil pouch contains sachets that absorb oxygen. Dispose of the sachets and the outer aluminum foil pouch with normal waste.

📦 Storage and Handling 122 words ▾

STORAGE Long-term storage temperature: 1 °C to 30 °C Permitted temperature excursions: –20 °C to 1 °C for up to 2 weeks Up to 50 °C for up to 1 week Use blood bag sets within 28 days after you open the outer aluminum foil pouch. To store unused blood bag sets, return them to the outer aluminum foil pouch and reclose the pouch with tape or a clip. Once you open the transparent packing wrap, you must use the blood bag set within 7 days, not exceeding 28 days from when you opened the outer aluminum foil pouch.

Each outer aluminum foil pouch contains sachets that absorb oxygen. Dispose of the sachets and the outer aluminum foil pouch with normal waste.

📋 Description ~2 min read ▾

11 DESCRIPTION The Reveos SELECT set has been evaluated for use with the Reveos system. The blood and fluid pathways of the blood bag set are steam-sterilized and are non-pyrogenic. The blood bag set is intended for use by appropriately trained phlebotomists who collect whole blood and by blood center personnel who process whole blood using the Reveos system.

The formulas of the active ingredients are provided in Tables 1 and 2. Table 1: CPD Active Ingredients Ingredients Molecular Formula Molecular Weight Dextrose (anhydrous) C 6 H 12 O 6 180.16 g/mol Trisodium Citrate (dihydrate) C 6 H 5 Na 3 O 7 2H 2 O 294.10 g/mol Citric Acid (monohydrate) C 6 H 8 O 7 H 2 O 210.14 g/mol Sodium Dihydrogen Phosphate (dihydrate) NaH 2 PO 4 2H 2 O 156.01 g/mol Water for Injection H 2 O 18.02 g/mol Each 70 mL of CPD contains: Dextrose (anhydrous) 1.624 g, Trisodium Citrate (dihydrate) 1.841 g, Citric Acid (monohydrate) 0.229 g, Sodium Dihydrogen Phosphate (dihydrate) 0.176 g, and water for injection up to 70 mL.

Table 2: AS-5 Active Ingredients Ingredients Molecular Formula Molecular Weight Dextrose (anhydrous) C 6 H 12 O 6 180.16 g/ mol Sodium Chloride NaCl 58.44 g/mol Mannitol C 6 H 14 O 6 182.17 g/mol Adenine C 5 H 5 N 5 135.13 g/mol Water for injection H 2 O 18.02 g/mol Each 111 mL of AS-5 contains: Dextrose (anhydrous) 0.908 g, Sodium Chloride 0.973 g, Mannitol 0.583 g, Adenine 0.035 g, and water for injection up to 111 mL. The PVC plasticized with DEHP bags are not made with natural rubber latex. The bags contain materials that have been tested to demonstrate the suitability of the containers for storing pharmaceutical solutions.

The bags are nontoxic and biologically inert. The blood bag set is a closed system and is not dependent upon entry of external air during administration. The blood bag set is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

📄 Package Label / Principal Display Panel 136 words ▾

PRINCIPAL DISPLAY PANEL - 70 mL Bag Pouch Case Label TERUMO Reveos ® SELECT CPD/AS-5 RED CELL PRESERVATIVE SOLUTION FOR COLLECTION OF 500mL OF BLOOD CAUTIONS: For single use only. Sterile fluid path, sterilized using steam. Non-pyrogenic fluid path.

Do not re-sterilize. Read the instructions carefully before use. Do not use if package is damaged.

Store between 1°C and 30°C Manufactured by : TERUMO BCT Vietnam Co., Ltd. Long Duc Industrial Park, Long Duc Commune, Long Thanh District, Dong Nai Province, Vietnam For : TERUMO BCT, Inc. 10811 W.

Collins ave. Lakewood, CO 80215 Rx ONLY D0000036575-A XXXX LOT : LOT # MFG DATE : Date of Mfg. EXPIRY DATE : Exp.

Date CAT. NO. : 6FO506A0 UNITS : 016 NDC : 82906-506-16 NDC (ISBT 128) PRINCIPAL DISPLAY PANEL - 70 mL Bag Pouch 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 BCT Vietnam CO., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Terumo BCT Vietnam CO., Ltd. 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.
← 82904-0414-50 · Memebox 82908-0357-00 · VIREO →
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.