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Additive Formula 3 Dextrose Monohydrate, TRISODIUM CITRATE DIHYDRATE, Sodium Chloride, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, Citric Acid Monohydrate, and Adenine 1.1 g/100mL; .59 g/100mL; .41 g/100mL; .28 g/100mL; .042 g/100mL; .03 g/100mL Solution — NDC 14537-0832-03 package photo

Additive Formula 3 Dextrose Monohydrate, TRISODIUM CITRATE DIHYDRATE, Sodium Chloride, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, Citric Acid Monohydrate, and Adenine 1.1 g/100mL; .59 g/100mL; .41 g/100mL; .28 g/100mL; .042 g/100mL; .03 g/100mL Solution

by Terumo BCT, Ltd · 6 POUCH in 1 CASE (14537-832-03) / 6 BAG in 1 POUCH (14537-832-01) / 100 mL in 1 BAG (14537-832-00)
NDC 14537-0832-03
🏷️ FDA NDC (as labeled) 14537-832-03 billing pads the product segment with a zero
Rx only Brand 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 →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 14537-832-03
Product NDC 14537-832
11-digit billing NDC 14537083203
UNII B22547B95K, 593YOG76RN, 451W47IQ8X, 2968PHW8QP, JAC85A2161, LX22YL083G
Application # BN001214
SPL Set ID 9a5247a1-cc05-442d-b2d0-950f887f03c2
Established class (EPC) Anti-coagulant; Calculi Dissolution Agent; Decreased Coagulation F
Mechanism of action Acidifying Activity; Calcium Chelating Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2002-05-29
Route INTRAVENOUS
Dosage form SOLUTION
Substance DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; CITRIC ACID MONOHYDRATE; ADENINE
Why two NDCs? The FDA registers this code as 14537-832-03 — 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 → 14537-0832-03. 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 applicationBN001214 (NDA)
Labeler code14537
First marketedMay 2002
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

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 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 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
Additive Formula 3 1.1 g/100mL; .59 g/100mL; .41 g/100mL; .28 g/100mL; .042 g/100mL; .03 g/100mLthis 14537-0832-03 Terumo 6 pouches — — FDA listed —
Additive Formula 3 1.1 g/100mL; .59 g/100mL; .41 g/100mL; .28 g/100mL; .042 g/100mL; .03 g/100mL 14537-0833-03 Terumo 200 ml — — 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

🏛️
2002
On the market since
May 2002
📍
2026
Currently FDA-listed
24 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
14537-0832-03 You're viewing this 6 POUCH in 1 CASE (14537-832-03) / 6 BAG in 1 POUCH (14537-832-01) / 100 mL in 1 BAG (14537-832-00) 2002-05-29 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 14537-832-03, 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: 14537-0832-03, written without dashes as 14537083203. 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 14537-0832-03, the first segment (14537) is the labeler code FDA assigned to Terumo BCT, Ltd; the middle segment (0832) 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 ⏱️ 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 35 words ▾

1 INDICATIONS AND USAGE Use only with Trima Accel red blood cell (RBC) apheresis collections. [See Dosage and Administration (2) .] Use only with Trima Accel red blood cell (RBC) apheresis collections. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION AS-3 is added to tubing sets after apheresis collections, after the donor has been disconnected. ( 2 ) AS-3 may only be used with the Trima Accel apheresis device. For instructions on the use of the solution see the device operator's manual. ( 2.1 ) Follow the directions for connecting the AS-3 bag to the tubing set of a blood collection system. ( 2.2 )

2.1General Dosing Information ADDITIVE SOLUTION FORMULA 3 (AS-3) is connected to the tubing set used for an apheresis RBC collection procedure after the collection has been completed. For automated RBC procedures, the recommended dose is determined by the apheresis device and metered into the tubing set by the apheresis device. To add the product manually, refer to the apheresis system operator's manual to determine the recommended dose.

For instructions on the use of the solution with the apheresis device and tubing set, see the device operator's manual.

2.2Administration Directions for connecting the ADDITIVE SOLUTION FORMULA 3 (AS-3) bag to the apheresis device. Automated RBC additive solution procedures: Connect ADDITIVE SOLUTION FORMULA 3 (AS-3) after the collection is over and the donor is disconnected. For automated addition of the product, the system will prompt you to connect the bag.

Remove the overwrap by pulling down at notch, and remove the AS-3 bag. Before use, perform the following checks: Ensure that the solution is the ADDITIVE SOLUTION FORMULA 3 (AS-3) and is within the expiration date. Inspect the bag in good light.

Do not use if the container is damaged, leaking or if there is any visible sign of deterioration. Check for leaks by gently squeezing the bag. If leaks are found, discard the bag.

Inspect the solution in good light. Use only if solution is clear and free of particulate matter. Bags showing cloudiness, haze, or particulate matter should not be used.

Protect from sharp objects. Remove the protective cap from the port on the bag. Connect the bag to the complementary luer of the apheresis device tubing set using aseptic technique and hang the solution.

Break the frangible connector. When you break frangible connectors, bend them in both directions to ensure that you break them completely. Failure to do so may result in restricted flow.

Proceed according to the apheresis device operator's manual. Manual RBC additive solution procedures: Connect ADDITIVE SOLUTION FORMULA 3 (AS-3) after the collection is over and the donor is disconnected. Seal the RBC product lines as close to the cassette as possible.

Remove the overwrap by pulling down at notch, and remove the ADDITIVE SOLUTION FORMULA 3 bag. Before use, perform the following checks: Ensure that the solution is the ADDITIVE SOLUTION FORMULA 3 (AS-3) and is within the expiration date. Inspect the bag in good light.

Do not use if the container is damaged, leaking or if there is any visible sign of deterioration. Check for leaks by gently squeezing the bag. If leaks are found, discard the bag.

Inspect the solution in good light. Use only if solution is clear and free of particulate matter. Bags showing cloudiness, haze, or particulate matter should not be used.

Protect from sharp objects. Remove the protective cap from the port on the bag. Insert the spike of the apheresis device tubing set into the spike port of the solution bag using aseptic technique and then hang the solution.

Proceed according to the apheresis device operator's manual.

💊 Dosage Forms and Strengths 83 words ▾

3 DOSAGE FORMS AND STRENGTHS 100 mL, 200 mL and 350 mL ADDITIVE SOLUTION FORMULA 3 (AS-3) products are sterile solutions in a Polyolefin bag. Each 100 mL contains: Dextrose Monohydrate USP 1.10 g; Trisodium Citrate Dihydrate USP 0.59 g; Sodium Chloride USP 0.41 g; Monobasic Sodium Phosphate Monohydrate USP 0.28 g; Citric Acid Monohydrate USP 0.042 g; Adenine USP 0.03 g; and Water for Injection USP. 100 mL, 200 mL, or 350 mL sterile fluid in a Polyolefin bag.

( 3 )

⛔ Contraindications 25 words ▾

4 CONTRAINDICATIONS DO NOT INFUSE ADDITIVE SOLUTION FORMULA 3 (AS-3) DIRECTLY TO THE DONOR. DO NOT INFUSE AS-3 DIRECTLY TO THE DONOR. ( 4 )

⚠️ Warnings and Cautions 75 words ▾

5 WARNINGS AND PRECAUTIONS Verify that the AS-3 bag has been securely attached to the system tubing set. Use aseptic technique throughout all procedures to ensure product quality. Do not reuse.

Discard unused or partially used solution bags. Verify that the AS-3 bag has been securely attached to the system tubing set. Use aseptic technique throughout all procedures to ensure product quality.

( 5 ) Do not reuse. Discard unused or partially used solution bags.

🤒 Adverse Reactions 147 words ▾

6 ADVERSE REACTIONS Citrate reactions or toxicity may occur with the infusion of blood products to patients. 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 of blood containing citrate. 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 Terumo BCT, Inc. at 1-877-339-4228 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

👥 Use in Specific Populations 21 words ▾

8 USE IN SPECIFIC POPULATIONS ADDITIVE SOLUTION FORMULA 3 (AS-3) has not been studied in controlled clinical trials with specific populations.

🧬 Clinical Pharmacology 72 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action ADDITIVE SOLUTION FORMULA 3 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: Adenine to support adenosine triphosphate (ATP) levels Citrate for membrane protection, anticoagulation and pH regulation Sodium (Sodium Chloride and Sodium Citrate) and dextrose for isotonicity Dextrose for RBC nutrition This solution has no pharmacological effect.

🧬 Mechanism of Action 69 words ▾

12.1Mechanism of Action ADDITIVE SOLUTION FORMULA 3 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: Adenine to support adenosine triphosphate (ATP) levels Citrate for membrane protection, anticoagulation and pH regulation Sodium (Sodium Chloride and Sodium Citrate) and dextrose for isotonicity Dextrose for RBC nutrition This solution has no pharmacological effect.

📦 How Supplied / Storage and Handling 52 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING ADDITIVE SOLUTION FORMULA 3 (AS-3) is a clear solution supplied in sterile and non-pyrogenic Polyolefin bags. SIZE CATALOG NUMBER NDC NUMBER QUANTITY PER CASE 100 mL 40832 14537-832-03 36 200 mL 40833 14537-833-03 30 350 mL 40834 14537-834-03 24 STORAGE Up to 25 °C. Protect from freezing.

📦 Storage and Handling 8 words ▾

STORAGE Up to 25 °C. Protect from freezing.

📋 Description ~2 min read ▾

11 DESCRIPTION ADDITIVE SOLUTION FORMULA 3 (AS-3) is designed to be added to packed RBC collected in apheresis procedures, and acts to preserve and extend the shelf life of packed RBC products for later transfusion to patients. The solution is intended to be metered by an apheresis device during apheresis procedures or added manually after a collection. Additive Solution Formula 3 (AS-3) is a clear solution that is steam-sterilized and non-pyrogenic.

It does not contain bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Table 1: Active Ingredients Ingredients Molecular Formula Molecular Weight Dextrose Monohydrate USP C 6 H 12 O 6 ∙ H 2 O 198.17 Trisodium Citrate Dihydrate USP C 6 H 9 Na 3 O 9 294.10 Sodium Chloride USP NaCl

58.44Monobasic Sodium Phosphate Monohydrate USP NaH 2 PO 4 ∙ H 2 O 137.99 Citric Acid Monohydrate USP C 6 H 8 0 7 ∙ H 2 O 210.14 Adenine USP C 5 H 5 N 5 135.13 Water for Injection USP H 2 O

18.00Each 100 mL of ADDITIVE SOLUTION FORMULA 3 (AS-3) contains: Dextrose Monohydrate USP 1.10 g; Trisodium Citrate Dihydrate USP 0.59 g; Sodium Chloride USP 0.41 g; Monobasic Sodium Phosphate Monohydrate USP 0.28 g; Citric Acid Monohydrate USP 0.042 g; Adenine USP 0.03 g; and Water for Injection USP. ADDITIVE SOLUTION FORMULA 3 is available in three volumes: 100 mL, 200 mL and 350 mL. The 100 mL bags are individually wrapped with a clear plastic film.

Six individually wrapped bags are then vacuum-sealed in a foil pouch, which serves as a vapor barrier to prevent water loss during storage. After you remove the individual solution bags from the foil pouch, you can either leave them in the clear plastic film or remove and discard it. Once the foil pouch has been opened, use all six of the solution bags within 2 weeks.

The 200 mL and 350 mL bags are individually wrapped with a clear plastic film. These larger volumes do not require the additional vapor barrier. Once the clear plastic film has been removed, use the solution within 2 weeks.

The Polyolefin bag is not made with natural rubber latex. The bag is made from a multilayered film. It 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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 14537-0820-03 · Terumo 14537-0833-03 · Terumo →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.