Anticoagulant Citrate Dextrose (ACD-A) Dextrose Monohydrate, sodium citrate, unspecified form, and Citric Acid Monohydrate .245 g/10mL; .22 g/10mL; .08 g/10mL Solution — NDC 14537-0820-03 package photo

Anticoagulant Citrate Dextrose (ACD-A) Dextrose Monohydrate, sodium citrate, unspecified form, and Citric Acid Monohydrate .245 g/10mL; .22 g/10mL; .08 g/10mL Solution

by Terumo BCT, Ltd · 50 POUCH in 1 CASE (14537-820-03) / 1 BAG in 1 POUCH (14537-820-01) / 50 mL in 1 BAG (14537-820-00)
NDC 14537-0820-03
🏷️ FDA NDC (as labeled) 14537-820-03 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 14537-820-03
Product NDC 14537-820
11-digit billing NDC 14537082003
UNII LX22YL083G, 1Q73Q2JULR, 2968PHW8QP
Application # BA110057
SPL Set ID 0130d7c8-d067-4528-beb7-166559c33be9
Established class (EPC) Anti-coagulant; Calculi Dissolution Agent; Inhibition Large Intestine Fluid/Electrolyte Absorpti
Mechanism of action Acidifying Activity; Calcium Chelating Activity
Physiologic effect Decreased Coagulation Factor Activity; Increased Large Intestinal Motility
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-07-18
Route INTRAVENOUS
Dosage form SOLUTION
Substance DEXTROSE MONOHYDRATE; SODIUM CITRATE, UNSPECIFIED FORM; CITRIC ACID MONOHYDRATE
Why two NDCs? The FDA registers this code as 14537-820-03 — 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 → 14537-0820-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerTerumo BCT, Ltd
FDA applicationBA110057 (ANDA)
Labeler code14537
First marketedJul 2023
Product typeHuman Prescription Drug
Portfolio6 products on file
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

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
Anticoagulant Citrate Dextrose (ACD-A) .245 g/10mL; .22 g/10mL; .08 g/10mLthis 14537-0820-03 Terumo 50 pouches FDA listed
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

🏛️
2023
On the market since
Jul 2023
📍
2026
Currently FDA-listed
3 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
14537-0820-03 You're viewing this 50 POUCH in 1 CASE (14537-820-03) / 1 BAG in 1 POUCH (14537-820-01) / 50 mL in 1 BAG (14537-820-00) 2023-07-18 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 14537-820-03, 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: 14537-0820-03, written without dashes as 14537082003. 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 14537-0820-03, the first segment (14537) is the labeler code FDA assigned to Terumo BCT, Ltd; the middle segment (0820) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Terumo BCT, Ltd. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Terumo BCT, 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.

📄 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 79 words

1 INDICATIONS AND USAGE ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is an anticoagulant intended for use only with devices that prepare Platelet Rich Plasma (PRP) products for extracorporeal use. [See Dosage and Administration (2) .] ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is an anticoagulant intended for use only with devices that prepare Platelet Rich Plasma (PRP) products for extracorporeal use. See the device operator's manual for additional information and complete usage instructions.

( 1 )

⏱️ Dosage and Administration ~2 min read

2 DOSAGE AND ADMINISTRATION ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is added to blood products collected for extracorporeal processing. ( 2 ) ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A may only be used with devices that prepare Platelet Rich Plasma (PRP) products for extracorporeal use. For instructions on the use of the solution see the device operator's manual.

( 2.1 ) Follow the directions for drawing ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A into a syringe for further processing of the collected blood product. ( 2.2 )

2.1General Dosing Information ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is added to blood products collected for extracorporeal processing. The solution is manually added to collected blood products to facilitate extracorporeal processing. The amount of solution added is specified by the manufacturer of the processing set.

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

2.2Administration Ensure solution is the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A and is within the expiration date. Inspect the solution bag. Do not use if the solution bag 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 drawing the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A from the solution bag.

When directed by the processing set instructions and device operator's manual: Open the foil pouch containing the solution by finding the notch in the foil overwrap and pulling down to present the clear overwrapped solution bag. Open the clear overwrap material by holding the peelable tabs between your thumb and forefinger. Gently pull the peelable tabs along the top to open the overwrap at both corners.

Once both corners are opened, gently peel along the length of the overwrap. Do not place the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A solution bag into the sterile field. The clear overwrap is not considered a sterile barrier.

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 solution bag. Ensure that the solution is the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A and is within the expiration date.

Inspect the solution in adequate light. Solution showing cloudiness, haze, or particulate matter should not be used. Aseptically prepare the Needleless Access Valve (NAV).

Using an appropriate syringe and luer, connect to the NAV. Draw into the syringe the amount of ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A required by the processing set instructions and device operator's manual. Remove the syringe from the NAV and proceed according to the processing set instructions and device operator's manual.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and solution bag permit.

💊 Dosage Forms and Strengths 59 words

3 DOSAGE FORMS AND STRENGTHS 50 mL ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is a sterile solution in a polyolefin solution bag. Each 100 mL contains: (%w/v) Citric Acid, Monohydrate 0.8 g; Dextrose Monohydrate 2.45 g; Sodium Citrate Dihydrate 2.2 g; and Water for Injection. 50 mL sterile fluid in a polyolefin solution bag. ( 3 )

Contraindications 31 words

4 CONTRAINDICATIONS NOT FOR PREPARATION OF BLOOD PRODUCTS FOR TRANSFUSION OR FOR DIRECT INTRAVENOUS INFUSION. NOT FOR PREPARATION OF BLOOD PRODUCTS FOR TRANSFUSION OR FOR DIRECT INTRAVENOUS INFUSION. ( 4 )

⚠️ Warnings and Cautions 108 words

5 WARNINGS AND PRECAUTIONS Do not use the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A unless the solution is clear and the container is intact and undamaged. Do not transfer the solution bag directly into the sterile field. Do not reuse.

Discard unused or partially used solution bags. Discard the product if the Needleless Access Valve (NAV) does not function as intended. Aseptically prepare the NAV before use.

Do not use the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A unless the solution is clear and the container is intact and undamaged. Use aseptic technique throughout all procedures to ensure donor safety and quality. ( 5 )

🤒 Adverse Reactions 152 words

6 ADVERSE REACTIONS Citrate reactions or toxicity may occur with the injection of blood products containing citrate anticoagulant. The recipient of the blood product 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 injection of blood products containing citrate anticoagulant. The recipient of the blood product containing citrate should be monitored for the signs and symptoms of citrate toxicity.

( 6 ) 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 .

👥 Use in Specific Populations 43 words

8 USE IN SPECIFIC POPULATIONS ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A has not been studied in controlled clinical trials with specific populations. ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A has not been studied in controlled clinical trials with specific populations.

🧬 Clinical Pharmacology 67 words

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A 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 for anticoagulation Dextrose for isotonicity This solution has no pharmacological effect.

🧬 Mechanism of Action 64 words

12.1Mechanism of Action ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A 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 for anticoagulation Dextrose for isotonicity This solution has no pharmacological effect.

📦 How Supplied / Storage and Handling 94 words

16 HOW SUPPLIED/STORAGE AND HANDLING ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is a clear sterile solution supplied in non-pyrogenic polyolefin solution bags. Each solution bag is individually wrapped in a clear overwrap. Each clear overwrap is then individually foil wrapped.

Neither the clear overwrap nor the foil overwrap can be considered a sterile barrier. This product has a sterile fluid pathway only. SIZE CATALOG NUMBER NDC NUMBER 50 mL 40820 Case: 14537-820-03 Foil: 14537-820-01 Bag: 14537-820-00 STORAGE Store up to 25 °C.

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

📦 Storage and Handling 16 words

STORAGE Store up to 25 °C. Avoid excessive heat. Protect from freezing. Protect from direct sunlight.

📋 Description ~1 min read

11 DESCRIPTION ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is designed to be added to blood products collected for extracorporeal processing, to prevent platelet activation and coagulation as blood moves throughout the extracorporeal processing set. The content of the solution bag is considered sterile. This product has a sterile fluid path only.

The clear overwrap is not considered a sterile barrier. The solution is non-pyrogenic, and it contains no bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1.

Table 1: Active Ingredients Ingredients Molecular Formula Molecular Weight (%w/v) Citric Acid, Monohydrate C 6 H 8 O 7 192.12 Dextrose Monohydrate C 6 H 12 O 6 ∙ H 2 O 198.17 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 CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A contains: (%w/v) Citric Acid, Monohydrate 0.8 g; Dextrose Monohydrate 2.45 g; Sodium Citrate Dihydrate 2.2 g; and Water for Injection. The solution bag is not made with natural rubber latex or PVC. The solution bag is made from a polyolefin film.

It contains materials that have been tested to demonstrate the suitability of the solution bag for storing pharmaceutical solutions. The solution contact layer is a polyolefin. The solution bag is nontoxic and biologically inert.

The solution bag is a closed system and is not dependent upon entry of external air during administration. The solution bag is covered with a clear overwrap to provide protection from the physical environment. The content of the solution bag is considered sterile.

This product has a sterile fluid path only. The clear overwrap is not considered a sterile barrier.

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.