HomeNDC Lookup › 57826-0455-02
Haemonetics Anticoagulant Citrate Phosphate Double Dextrose Solution (CP2D) CITRIC ACID MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, ANHYDROUS 464; 32.7; 22.2; 263 mg/mL; mg/mL; mg/mL; mg/mL Solution, 250 mL — NDC 57826-0455-02 package photo

Haemonetics Anticoagulant Citrate Phosphate Double Dextrose Solution (CP2D) CITRIC ACID MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, ANHYDROUS 464; 32.7; 22.2; 263 mg/mL; mg/mL; mg/mL; mg/mL Solution, 250 mL

by Haemonetics Corporation · 250 mL in 1 BAG (57826-455-02)
NDC 57826-0455-02
🏷️ FDA NDC (as labeled) 57826-455-02 billing pads the product segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ Data synced Jul 14, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 57826-455-02
Product NDC 57826-455
11-digit billing NDC 57826045502
Application # BN000127
SPL Set ID 1c149b86-5f9d-4e60-8f17-4ec03ca80563
Established class (EPC) 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 F
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2024)
Route EXTRACORPOREAL
Dosage form SOLUTION
Substance ANHYDROUS DEXTROSE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE
GCN Seq No 084232
GCN 53438
HICL code 048580
Ingredient (HICL) Citric/Sod Citrat/Sod Phos/Dex
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M9
Therapeutic class — intermediate (HIC2) Drugs Given To Alter Blood Coagulation
HIC3 code M9J
Therapeutic class — specific (HIC3) Citrates As Anticoagulants
AHFS code 20:12.04.92
AHFS class Anticoagulants, Miscellaneous
FDB label name CITRATE PHOS 2X DEXTROSE(CP2D)
FDB brand name Citrate Phos 2X Dextrose(Cp2D)
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 57826-455-02 — 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 → 57826-0455-02. 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

LabelerHaemonetics Corporation
FDA applicationBN000127 (NDA)
Labeler code57826
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.

🩺 Clinical

Label name CITRATE PHOS 2X DEXTROSE(CP2D) Ingredient Citric/Sod Citrat/Sod Phos/Dex
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 DailyMedingredient 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 systemPer mLPer 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Haemonetics Anticoagulant Citrate Phosphate Double Dextrose Solution (CP2D) 464; 32.7; 22.2; 263 mg/mL; mg/mL; mg/mL; mg/mLthis 57826-0455-02 Haemonetics 250 ml Discontinued
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

📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 NDCDescription Marketing startStatus
57826-0455-02 You're viewing this 250 mL in 1 BAG (57826-455-02) 2013-01-10 Inactivated by FDA

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 57826-455-02, 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: 57826-0455-02, written without dashes as 57826045502. 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 57826-0455-02, the first segment (57826) is the labeler code FDA assigned to Haemonetics Corporation; the middle segment (0455) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Haemonetics 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 ~1 min read

I. Indications for Use The Haemonetics 250mL Anticoagulant Citrate Phosphate Double Dextrose (CP2D) and 250mL Additive Solution Formula 3 (AS-3) nutrient solution are intended to be used only with automated apheresis devices for collecting human blood and blood components. The anticoagulant solution is metered by the apheresis machine into the collected whole blood.

It is not to be infused directly into the donor. After the anticoagulant is used, the bag in which it was contained is discarded. When collecting plasma in the RBCP protocol, the plasma is collected into an empty plasma collection bag.

One hundred milliliters (100ml) of AS-3 is transferred into one RBC collection bag when using the RBCP protocol or 2 separate bags when using the 2RBC protocol. AS-3 solution provides nutrients to keep the red blood cells viable for 42 days when refrigerated. CP2D is also indicated for the collection of FFP and PF24 plasma, collected and stored plasma collected using the 822, 822-2P and 822F-2P disposable sets may be frozen within 8 hours (FFP) or within 24 hours which includes 8 hours room temperature storage and 16 hours refrigeration storage (PF24).

The 300mL AS-3 is used in conjunction with automated red blood cell washing devices. AS-3 serves as the nutrient solution for storage of the red blood cell product after deglycerolization. The red blood cells are washed using the Model 215 System.

AS-3 is used for priming the disposable and for the last wash of the red blood cells. The washed cells are then re-suspended in 100mL of the AS-3 before transfer into a product collection bag or storage bag. Additive Solution Formula 3 (AS-3) provides nutrients to keep the washed red blood cells viable for up to 14 days after washing when refrigerated.

Neither the CP2D nor the AS-3 container is used for the storage of blood or blood components.

⏱️ Dosage and Administration 50 words

Dosage and Administration: CP2D Anticoagulant Solution and AS-3 Solution may be used with Haemonetics apheresis devices. See the Haemonetics Operation Manual for full operating instructions. Prior to use of the solutions, check the solutions for leaks by squeezing each of the bags firmly. If leaks are found, discard the solution.

💊 Dosage Forms and Strengths 167 words

Dosage Form The container for all CP2D and AS-3 solutions is a flexible polyvinyl chloride (PVC) bag sized for holding the appropriate amount of solution. The bag has a single port that is used for bag filling. The port is sealed after filling with a male luer assembly (CP2D) or female luer assembly (AS-3).

Both the male and female luers are gamma irradiated prior to use. The plastic bag is contained in an overwrap which is added prior to sterilization. The formulations for these products are as follows: Citrate Phosphate Double Dextrose Solution (CP2D) Each 100 mL contains: Citric Acid (Monohydrate), USP 0.327 g Sodium Citrate (Dihydrate), USP 2.630 g Monobasic Sodium Phosphate (Monohydrate), USP 0.222 g Dextrose (Anhydrous), USP 4.640 g Additive Solution 3 (AS-3) Each 100mL contains: Citric Acid (Monohydrate), USP 0.042 g Monobasic Sodium Phosphate (Monohydrate), USP 0.276 g Sodium Chloride, USP 0.410 g Adenine, USP 0.030 g Dextrose (Anhydrous), USP 1.000 g Sodium Citrate (Dihydrate), USP 0.588 g containing 15 mEq of Sodium.

⚠️ Warnings and Cautions ~1 min read

IV. Warnings and Cautions Contraindications: None known Precautions for use: • Solutions are NOT INTENDED FOR DIRECT INFUSION. • Do not use if particulate matter is present or if the solution is cloudy Note: Some opacity of the plastic container due to moisture absorbance by the PVC during the sterilization process may be observed. This is normal and does not affect the quality or the safety of the product.

This white, hazy appearance will diminish gradually over time. This advice only applies to the plastic container. Do not use if the solution itself is cloudy or contains particulate matter. •Do not use if the container is damaged, leaking or if there is any visible sign of deterioration.

Note: The over wrap serves as a moisture barrier. Upon removing the solution bag, small droplets of condensation may be present in the packaging. This is considered normal.

After removing the over wrap gently squeeze the inner bag which protects the sterility of the solution. Discard if any leaks are observed or if an excessive amount of solution is noted within the over wrap. • Do not reuse solution. Discard any unused or partially used solutions. • Protect from sharp objects. • Verify that solutions have been appropriately connected to avoid leaks. • The set should be loaded and primed for use within 8 hours of the start of the collection. • Carry out the apheresis procedure in accordance with the detailed instructions of the manufacturer of the apheresis device.

🤒 Adverse Reactions 71 words

Adverse Reactions: Donors being reinfused with citrated blood or blood components may experience side effects due to the presence of citrate. Patients being transfused with the blood components could also experience a reaction to the citrated blood components. The major symptom experienced by donors is paraesthesia.

Should this occur the reinfusion should be stopped or the reinfusion rate decreased. In the event of inadvertent bolus of the product administer calcium gluconate.

🆘 Overdosage 43 words

Overdosage: Both solutions are intended to be used only with automated apheresis devices for collecting human blood and blood components. CP2D is used as an anticoagulant solution and AS-3 is intended for use a nutrient solution. Neither solution is intended for direct infusion.

📦 How Supplied / Storage and Handling 36 words

How Supplied: 250mL CP2D Anticoagulant Solution is supplied in flexible PVC containers with a sterile, non-pyrogenic fluid path. 250mL and 300mL AS-3 Nutrient Solution is supplied in flexible PVC containers with a sterile, non-pyrogenic fluid path.

📦 Storage and Handling 12 words

Storage and Handling: Room temperature (25°C/77°F). Avoid excessive heat. Protect from freezing.

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