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Pall Sterile Cord Blood Collection Unit .921 g/35mL; .114 g/35mL; .0078 g/35mL; .893 g/35mL Solution, 35 mL — NDC 79403-0791-01 package photo

Pall Sterile Cord Blood Collection Unit .921 g/35mL; .114 g/35mL; .0078 g/35mL; .893 g/35mL Solution, 35 mL

by Global Life Sciences Solutions USA LLC · 35 mL in 1 BAG (79403-791-01)
NDC 79403-0791-01
🏷️ FDA NDC (as labeled) 79403-791-01 billing pads the product segment with a zero
This package
Contains35 mL Pack sizes2 compare ↓
Also comes in: 35 ml 79403-0791-08
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) 79403-791-01
Product NDC 79403-791
11-digit billing NDC 79403079101
UNII 1Q73Q2JULR, 2968PHW8QP, 593YOG76RN, LX22YL083G
Application # BN800222
SPL Set ID aa9340b7-cc63-e17d-e053-2a95a90ad4d9
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 2025-12-18
Route INTRAVENOUS
Dosage form SOLUTION
Substance SODIUM CITRATE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; DEXTROSE MONOHYDRATE
Why two NDCs? The FDA registers this code as 79403-791-01 — 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 → 79403-0791-01. 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.

🏭 Manufacturer & labeler

LabelerGlobal Life Sciences Solutions USA LLC
FDA applicationBN800222 (NDA)
Labeler code79403
First marketedDec 2025
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 E4GA8884NN
    Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
  • 35 g / 35 mL 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.
Try another pack size: 35 ml
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
Pall Sterile Cord Blood Collection Unit .921 g/35mL; .114 g/35mL; .0078 g/35mL; .893 g/35mLthis 79403-0791-01 Global 35 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

🏛️
2025
On the market since
Dec 2025
📍
2026
Currently FDA-listed
1 year 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
79403-0791-01 You're viewing this 35 mL in 1 BAG (79403-791-01) 2011-03-16 Active
79403-0791-08 35 mL in 1 BAG (79403-791-08) 2025-12-18 Active

Pack size FAQ

What quantity is in NDC 79403-0791-01?
NDC 79403-0791-01 contains 35 mL — 35 ml in 1 bag.
What is the difference between NDC 79403-0791-01 and NDC 79403-0791-08?
Both are Pall Sterile Cord Blood Collection Unit .921 g/35mL; .114 g/35mL; .0078 g/35mL; .893 g/35mL Solution — the drug itself is identical. NDC 79403-0791-01 is the 35 mL package, while NDC 79403-0791-08 is the 35 ml package.
What NDC number is used to bill for this package of Pall Sterile Cord Blood Collection Unit .921 g/35mL; .114 g/35mL; .0078 g/35mL; .893 g/35mL Solution?
Bill NDC 79403-0791-01 — the 11-digit billing format is 79403079101. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 79403-791-01, 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: 79403-0791-01, written without dashes as 79403079101. 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 79403-0791-01, the first segment (79403) is the labeler code FDA assigned to Global Life Sciences Solutions USA LLC; the middle segment (0791) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Global Life Sciences Solutions USA LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 35 ml (79403-0791-08). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Global Life Sciences Solutions USA LLC 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 ⚠️ Warnings and Cautions 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 54 words ▾

Indications and Usage Section For collection of up to 210 ml of umbilical cord blood. Use aseptic technique. Contents inside overwrap pouch, within the foil envelope, are sterile and acceptable for use in a sterile field if pouch is unopened and undamaged; visual inspection to confirm the integrity of overwrap pouch should be performed.

⚠️ Warnings and Cautions 26 words ▾

WARNINGS Making multiple punctures of the umbilical cord to increase collection volume may increase the risk of contamination. Do not irradiate collected cord blood or components.

📦 How Supplied / Storage and Handling 29 words ▾

HOW SUPPLIED The Collection Unit inside the overwrap pouch, within the foil envelope, are sterile and acceptable for use in a sterile field if pouch is unopened and undamaged.

📋 Description 21 words ▾

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION (CPD) Sterile, non-pyrogenic fluid path. Sterilized by steam. This product is free of natural rubber latex.

💬 Information for Patients ~1 min read ▾

INFORMATION FOR PATIENTS For customer service, call: 1.800.645.6578 DonorCare is a registered trademark of ITL Corporation, Canberra, Australia. Produced under license from ThermoGenesis Corp Ensure DonorCare® Needle Guard (DCNG) is positioned on the tubing between the needle hub and Pinch Clamp. Engage Pinch Clamp.

Ensure tethered cap is placed securely on the air vent. Using aseptic technique, insert needle into umbilical vein, disengage Pinch Clamp to collect cord blood, mixing frequently, according to standard procedures. Upon completion of collection, engage Pinch Clamp then withdraw needle from umbilical vein.

Slide the DCNG midway over the needle hub. While holding the sides of DCNG near front, grasp tubing and pull smoothly, pulling needle into the DCNG until it locks into place. Confirm that needle is locked by listening for the second click as the needle is drawn into the DCNG.

Ensure that tubing cannot be pulled through DCNG. Place the bag on a work surface. While holding the tubing above the bag, open the tethered cap on the air vent.

Allow the blood to drain from the tubing into the bag. When the tubing has been drained, hold tubing vertical and seal tubing directly below the Y-piece with air vent. Detach and discard needle, DCNG, Pinch Clamp, Air Vent and tubing according to standard procedures.

Determine amount of anticoagulated blood collected. If required, add sedimenting agent to CPD anticoagulated blood through Sample Port using a syringe according to standard procedures. Mix well.

Take care to strip and mix any blood in tubing. Load bag into centrifuge cup. It is suggested that a means of support is used to prevent bag from collapsing and to reduce wrinkles.

Centrifuge according to standard procedures to obtain mononuclear cell-rich plasma.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 79401-0002-50 · ORR 79458-0003-01 · Natural →
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.