Home › NDC Lookup › Ingredients › Trisodium Citrate Dihydrate › 81839-0782-02
Anticoagulant Sodium Citrate Trisodium Citrate Dihydrate 40 mg/mL Solution — NDC 81839-0782-02 package photo

Anticoagulant Sodium Citrate Trisodium Citrate Dihydrate 40 mg/mL Solution

by CSL Plasma Inc. · 30 BAG in 1 CARTON (81839-782-02) / 250 mL in 1 BAG (81839-782-01)
NDC 81839-0782-02
🏷️ FDA NDC (as labeled) 81839-782-02 billing pads the product segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ Data synced 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

⚠️
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 2026. 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) 81839-782-02
Product NDC 81839-782
11-digit billing NDC 81839078202
UNII B22547B95K
Application # BA125750
SPL Set ID 1798dd96-5ae7-4a8b-b433-24ca9b38d863
Established class (EPC) Anti-coagulant; Calculi Dissolution Agent
Mechanism of action Acidifying Activity; Calcium Chelating Activity
Physiologic effect Decreased Coagulation Factor Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 2022-07-01
Route INTRAVENOUS
Dosage form SOLUTION
Substance TRISODIUM CITRATE DIHYDRATE
Why two NDCs? The FDA registers this code as 81839-782-02 — 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 → 81839-0782-02. 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

LabelerCSL Plasma Inc.
FDA applicationBA125750 (ANDA)
Labeler code81839
First marketedJul 2022
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

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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 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.

2 inactive ingredients 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 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
Anticoagulant Sodium Citrate 40 mg/mLthis 81839-0782-02 CSL 250 ml — — Discontinued —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2022
On the market since
Jul 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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
81839-0782-02 You're viewing this 30 BAG in 1 CARTON (81839-782-02) / 250 mL in 1 BAG (81839-782-01) 2022-07-01 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 81839-782-02, 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: 81839-0782-02, written without dashes as 81839078202. 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 81839-0782-02, the first segment (81839) is the labeler code FDA assigned to CSL Plasma Inc.; the middle segment (0782) 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?
CSL Plasma Inc. 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 ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description
🎯 Indications and Usage 61 words ▾

1. INDICATIONS AND USAGE ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures. [See Dosage and Administration (2) .] ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2. DOSAGE AND ADMINISTRATION ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP is added to tubing sets during apheresis procedures. ( 2 ) ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP may only be used with apheresis devices.

For instructions on the use of the solution see the apheresis device operator's manual. ( 2.1 ) Follow the directions for connecting the ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP bag to the apheresis system. ( 2.2 ) 2.1.

General Dosing Information ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP is added to tubing sets during apheresis procedures. The solution bag is connected to the tubing set in an apheresis collection. The recommended dose is determined by the apheresis device and metered into the tubing set by the apheresis device.

It is not intended for direct intravenous infusion. For instructions on the use of the solution with the apheresis device and tubing set, see the device operator's manual. 2.2.

Administration Ensure solution is the ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP and is within the expiration date Inspect the bag. Do not use if the container is damaged, leaking, or if there is any visible sign of deterioration Use only if solution is clear and free of particulate matter Protect from sharp objects. Directions for connecting the ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP bag to the apheresis device.

At the prompt to connect anticoagulant to the apheresis device tubing set: Remove the overwrap by pulling down at the notch, and remove the ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP bag. Before use, perform the following checks [see Warnings and Precautions (5) ] : Check for leaks by gently squeezing the bag. If leaks are found, discard the bag Ensure that the solution is the ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP and is within the expiration date Inspect the solution in good light.

Bags showing cloudiness, haze, or particulate matter should not be used Remove the twist off port on the bag Connect the bag to the apheresis device tubing set using aseptic technique and hang the solution Proceed according to the apheresis device operator's manual Drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

💊 Dosage Forms and Strengths 59 words ▾

3. DOSAGE FORMS AND STRENGTHS 250 mL ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP is a sterile solution in a PVC bag. Each 100 mL contains: Sodium Citrate (dihydrate) 4.0 g; Water for Injection to 100 mL, (pH adjusted with citric acid). Approximate millimoles of Sodium Citrate: 13.6. 250 mL sterile fluid in a PVC bag. ( 3 )

⛔ Contraindications 33 words ▾

4. CONTRAINDICATIONS DO NOT INFUSE ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP DIRECTLY TO THE DONOR. DO NOT INFUSE ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP DIRECTLY TO THE DONOR. ( 4 )

⚠️ Warnings and Cautions 107 words ▾

5. WARNINGS AND PRECAUTIONS Verify that the ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP has been securely attached to the anticoagulant (AC) line on the system tubing set. Use aseptic technique throughout all procedures to ensure donor safety and quality.

Single-use container. Do not reuse. Discard any unused or partially used product.

Rx only Verify that the ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP has been securely attached to the anticoagulant (AC) line on the system tubing set. Use aseptic technique throughout all procedures to ensure donor safety and quality. Single-use container, do not reuse.

Discard any unused or partially used product. Rx only ( 5 )

🤒 Adverse Reactions 159 words ▾

6. ADVERSE REACTIONS Citrate reactions or toxicity may occur with the infusion of blood products to patient and return of blood containing citrate anticoagulant to donors. The recipient of the blood containing citrate should be monitored for the signs and symptoms of citrate toxicity.

The signs and symptoms of citrate toxicity begin with paresthesia, a "tingling" sensation around the mouth or in the extremities, followed by severe reactions that are characterized by hypotension and possible cardiac arrhythmia. Citrate toxicity may occur more frequently in patients who are hypothermic, have impaired liver or renal function, or have low calcium levels because of an underlying disease. Citrate reactions or toxicity may occur with the infusion and return of blood containing citrate anticoagulant.

The recipient of the blood containing citrate should be monitored for the signs and symptoms of citrate toxicity. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact CSL Plasma Inc. at 1-833-275-0044 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

👥 Use in Specific Populations 42 words ▾

8. USE IN SPECIFIC POPULATIONS ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP has not been adequately studied in controlled clinical trials with specific populations. ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP has not been studied in controlled clinical trials with specific populations.

🧬 Clinical Pharmacology 62 words ▾

12. CLINICAL PHARMACOLOGY 12.1. Mechanism of Action ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP 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 anticoagulant This solution has no pharmacological effect.

🧬 Mechanism of Action 59 words ▾

12.1. Mechanism of Action ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP 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 anticoagulant This solution has no pharmacological effect.

📦 How Supplied / Storage and Handling 80 words ▾

16. HOW SUPPLIED/STORAGE AND HANDLING ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP is a clear solution supplied in sterile and non-pyrogenic PVC bags. The bags are packaged 30 bags per case.

SIZE CATALOG NUMBER NDC NUMBER 250 mL 1000782 Bag: 81839-782-01 Case: 81839-782-02 STORAGE Store at 20° to 25°C (68°to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing.

📦 Storage and Handling 37 words ▾

STORAGE Store at 20° to 25°C (68°to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing.

📋 Description 205 words ▾

11. DESCRIPTION ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP is designed to be metered by an apheresis device in apheresis procedures, to prevent platelet activation and coagulation as blood moves throughout the extracorporeal unit (tubing set) in an apheresis procedure. The solution is sterile and non-pyrogenic, and it contains no bacteriostatic or antimicrobial agents.

Sterilized with steam. The formulas of the active ingredients are provided in Table 1. Table 1: Active Ingredients Ingredients Molecular Formula Molecular Weight Sodium Citrate Dihydrate C 6 H 9 Na 3 O 9 294.10 Water for Injection H 2 O

18.00Each 100 mL of ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP contains: Sodium Citrate (dihydrate) 4.0 g; and Water for Injection to 100 mL (pH adjusted with citric acid). Approximate millimoles of sodium citrate: 13.6. The PVC bag is not made with natural rubber latex.

The bag contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration.

The bag is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 81831-0101-01 · Chuanzongbao 81842-0049-01 · Coating →
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.