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MTL1 Leucoflex Anticoagulant Citrate Phosphate Dextrose Solution with AS-1 Kit, 1 kit — NDC 14498-0001-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

MTL1 Leucoflex Anticoagulant Citrate Phosphate Dextrose Solution with AS-1 Kit, 1 kit — NDC 14498-001-01 (Billing 14498-0001-01)

by Maco Productions · 1 KIT in 1 KIT

This is a package of 1 kit of MTL1 Leucoflex Anticoagulant Citrate Phosphate Dextrose Solution with AS-1 Kit from Maco Productions, marketed since Nov 2005 and currently FDA-listed. It is this product's only package size.

NDC 14498-0001-01
🏷️ FDA NDC (as labeled) 14498-001-01 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 14498-001-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
14498 labeler · 001 product · 01 package
Package marketed since
Nov 21, 2005
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 1449800101 3
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 14498-001-01
Product NDC 14498-001
11-digit billing NDC 14498000101
Application # BN040083
SPL Set ID 0a0b25d1-8fa1-6cd4-e054-00144ff8d46c
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2005-11-21
Route INTRAVENOUS
Dosage form KIT
Why two NDCs? The FDA registers this code as 14498-001-01 — 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 → 14498-0001-01. 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
14498-0001-01 You're viewing this Main listing 1 KIT in 1 KIT 2005-11-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
MTL1 Leucoflexthis 14498-0001-01 Maco 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

🏛️
2005
On the market since
Nov 2005
📍
2026
Currently FDA-listed
21 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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

LabelerMaco Productions
FDA applicationBN040083 (NDA)
Labeler code14498
First marketedNov 2005
Product typeHuman Prescription Drug
Portfolio5 products on file

More NDCs from Maco Productions labeler code 14498

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.
⚠️ Warnings 📋 Description ⚠️ Precautions 📖 Instructions for Use 📄 Package Label / Principal Display Panel
⚠️ Warnings 59 words ▾

WARNING Avoid contact with sharp objects. DO NOT USE if the overwrap or blood bag system shows any signs of deterioration. DO NOT USE if the solutions are not clear. Dispose of all system components that have been contaminated with blood in a biohazard container as per your institution's SOP. Dispose of all sharps as per your institution's SOP.

📋 Description 83 words ▾

Description The Leucoflex MTL1 product consists of a blood collection system with 70mL of CPD for the collecion of 500 +/- 50mL of blood and 110mL of AS-1 Additive Solution. They are supplied with sterile, non-pyrogenic fluid pathways. The product as supplied includes an in-line leukoreduction filter known as Leucoflex MTL1, storage containers for blood components and tubing, a sample diversion pouch (Bactivam), a vacuum tube adapter (Vacuvam), and a protective shield for the used needle (Secuvam).

Representative Product Drawing Reprsentative Product Drawing

⚠️ Precautions 181 words ▾

CAUTIONS Do not fold or squeeze the Leucolex MTL1 filter. Inappropriate handling may adversely affect filtration. Check for kinks in the tubing prior to collection and filtration.

Rx only. The protective shield for needle Secuvam (A) and the vacuum tube adapter Vacuvam (B) features of the collection set aid in the safe collection of vacuum tube samples from the sample diversion pouch Bactivam (C) and the disposal of donor needles after blood collection by providing protection from accidental needlestick. All or part of this medical device is made of PVC plasticized with DEHP.

According to some studies, DEHP could potentially be harmful to the reproductive system of male fetuses. The prescriber is solely responsible for choosing to use this device on women who are either pregnant or breast-feeding, or on young male infants. Nevertheless, DEHP-plasticized PVC is in compliance with the European Pharmacopeia.

Risks linked to the reuse: Septic risk. All manufacturing processes and all components in contact with the donors, the users and the blood components dedicated to the patients are not made with natural rubber latex. A.jpg B.jpg C.jpg

📖 Instructions for Use ~3 min read ▾

COLLECTION AND SAMPLING PROCEDURE Before Donation 1) Peel open the transparent overwrap (D) using the corner flap. 2) Support blood bag system as far as possible below donor arm, ideally on an automated blood mixer. Note: it is recommended that the primary bag on the mixer lies with the tubing on the lower side of the mixer holding plate.

3) Apply tourniquet or pressure cuff (inflate to approximately 60 mm Hg). 4) Prepare venipuncture site as per your SOP. 5) Ensure that the donor line is not twisted or tangled.

Venipucture 1) Open the needle cap (E1) using the following procedure: a) Twist the needle cap, thus breaking the seal. b) Lift the cap off of the needle (E2) in a straight line taking special care not to touch the needle in the process (F). Keep hands behind the needle at all times during set use and disposal. 2) Perform the venipuncture 3) After the needle has been inserted, introduce the Secuvam onto the hub of the needle.

4) Tape the Secuvam onto the donor's arm. Note: if the Secuvam causes discomfort to the donor or decreases the blood flow because of the angle of the needle, leave the Secuvam on the tubing, behind the needle hub (G) during collection. Secure the needle into the Secuvam at the end of the donation (H).

After Venipuncture 1) Ensure that the clamp between the Bactivam pouch and the donation line is open. 2) Ensure that the Bactivam pouch is held below the level of the venipuncture site, and is supported at all times. 3) Allow blood to run into the Bacivam pouch until the pouch fills (approximately 30ml) (I).

4) Close the red clamp (I1) on the transfer line to the Bactivam pouch, by holding the clamp in one hand and squeezing the two edges together, until it locks (a click my be heard). Note: the red clamp cannot be opened after it has snapped shut. 5) Break the break-away cannula (I2) on the donor line by holding the cannula in one hand and the plastic Y-junction in the other and snapping the cannula both left and right to ensure a clean break.

Allow the donation procedure to continue, ensuring that the blood bag is mixed immediately when blood flows into the primary bag. Note: This step may be done prior to venipuncture if the Blue Roberts clamp (I3) on the donor line is closed prior to breaking the break-away cannula. 6) If using an automated mixer, open the mixer clamp and start the mixer at this point.

Note: it is recommended that the primary bag on the mixer lies with the tubing on the lower side of the mixer holding plate. 7) After approximately 50 ml of blood enters the primary bag, mix thoroughly (when possible). Note: Collect the quantity of blood stated on the blood bag label.

Sampling Procedure Note: this is done during the donation. Avoid air in the collection of sample tubes from the diversion pouch to ensure adequate sample volume and avoid hemolysis. 1) Hold the Bactivam pouch with the Vacuvam below it (J), to ensure good blood flow from the pouch to the sampling device, and no introduction of air into the sampling tubes.

2) Remove the cap of the Vacuvam sampling device, and retain for later use (when possible). 3) Introduce a vacuum sampling tube by holding the barrel of the Vacuvam and directing the sample tube cap directly onto the needle inside the device (J1). 4) Blood is drawn automatically into the sampling tube, stopping at the appropriate volume.

5) When the sample tube stops filling, withdraw the tube, ensuring that the tube is pulled out of the barrel in a straight line. 6) Repeat the sampling procedure steps (3 to 5) with all remaining sampling tubes. 7) When all samples have been taken, replace the Vacuvam cap to prevent accidental access to the interior needle (when possible).

8) Mix the blood in the primary bag regularly (approximately every 100 ml or every minute). After Donation 1) Once the required volume of blood has been collected, close the red clamp on the donor line (J2), at least 12 inches above the primary bag. Note: if necessary, place a Hemostat on the collec… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 45 words ▾

Labels: Bag 1 Anticoagulant Citrate Phosphate Dextrose Solution USP; Bag 4 Additive Solution AS-1; Overwrap; Carton Anticoagulant Citrate Phosphate Dextrose Solution, USP - Bag 1 Label Additive Solution AS-1 - Bag 4 Label OVERWRAP LABEL CARTON LABEL Bag 1 Bag 4 Overwrap Label Carton 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 ✓ Available
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 Maco Productions. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Maco Productions 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.
← 14474-0044-01 · Sai 14498-0002-01 · Maco →
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.