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Volumex Iodinated I-131 Albumin .025 mCi/mL Injection, Solution, 1 mL — NDC 50914-7720-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Volumex Iodinated I-131 Albumin .025 mCi/mL Injection, Solution, 1 mL — NDC 50914-7720-8 (Billing 50914-7720-08)

by Iso-Tex Diagnostics, Inc. · 1 mL in 1 SYRINGE, PLASTIC

This is a package of 1 mL of Volumex Iodinated I-131 Albumin .025 mCi/mL Injection, Solution from Iso-Tex Diagnostics, Inc., marketed since Aug 1993 and currently FDA-listed. It is this product's only package size.

NDC 50914-7720-08
🏷️ FDA NDC (as labeled) 50914-7720-8 billing pads the package 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 50914-7720-8 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
50914 labeler · 7720 product · 8 package
Package marketed since
Aug 1, 1993
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5091477208 2
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50914-7720-8
Product NDC 50914-7720
11-digit billing NDC 50914772008
NCPDP billing unit EA — each (per item)
UNII ACH35131L1
Application # BLA017837
SPL Set ID 812240e4-fc28-46c2-92f3-1ba4e029645a
Mechanism of action Radiopharmaceutical Activity
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1993-08-01
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance HUMAN SERUM ALBUMIN I-131
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 087845
GCN 57867
HICL code 047851
Ingredient (HICL) Albumin, Iodinated I-131
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z5
Therapeutic class — intermediate (HIC2) Radiopharmaceuticals/Radiopharmaceutical Adjuvants
HIC3 code Z5D
Therapeutic class — specific (HIC3) Radioactive Diagnostics, General
AHFS code 36:00.00.00
AHFS class Diagnostic Agents
FDB label name VOLUMEX SYRINGE
FDB brand name Volumex
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 087845
  • GCN: 57867
  • HICL (First Databank): 047851
  • AHFS class code: 36:00.00.00
Why two NDCs? The FDA registers this code as 50914-7720-8 — a 5-4-1 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 package segment → 50914-7720-08. 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

Label name VOLUMEX SYRINGE Ingredient Albumin, Iodinated I-131

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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
50914-7720-08 You're viewing this Main listing 1 mL in 1 SYRINGE, PLASTIC 1993-08-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Volumex .025 mCi/mLthis 50914-7720-08 Iso-Tex 1 ml — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
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 & biosimilar status

🏛️
1976
First FDA approval
Feb 1976
📍
2026
Currently FDA-listed
50 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Megatopeiodinated I-131 albumin
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII ZIF514RVZR
    A protein derived from human blood plasma. In medicines, it acts as a stabilizer and binder, helping maintain drug potency and form, and may improve how the medication disperses or dissolves in the body.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.

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.

Manufacturer & labeler

LabelerIso-Tex Diagnostics, Inc.
FDA applicationBLA017837 (BLA)
Labeler code50914
First marketedAug 1993
Product typeHuman Prescription Drug
Portfolio3 products on file

More NDCs from Iso-Tex Diagnostics, Inc. labeler code 50914

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.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 26 words ▾

INDICATIONS AND USAGE Volumex (Iodinated I 131 Allbumin injection) is indicated for use in determinations of total blood and plasma volumes and in protein turnover studies

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Volumex (Iodinated I 131 Albumin Injection) is administered intravenously. Parenteral drug products should be inspected visually for particulate matter and abnormal coloration prior to administration whenever solution and container permit. Volumex (Iodinated I 131 Albumin Injection) may be colorless to very pale yellow.

Solutions with excessive coloration should not be used. When a procedure such as a blood volume or a circulation time determination is to be repeated, the total dosage administered in any one week should not exceed 200 microcuries. To minimize the uptake of radioactive iodine by the thyroid, prior administration of Lugol’s Solution (Strong Iodine Solution USP) may be used.

Ten drops of Lugol’s Solution three times daily, beginning at least 24 hours before administration of Volumex and continuing for one or two weeks thereafter, is a suitable dose. Complete assay data for each single unit dose are provided on the container. Note: The expiration date given on the container pertains to the biologic properties of the material and not to the radioactivity level.

It is important to make certain that the radioactivity in the dose at the time of administration is sufficient for the intended use. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. Note: A shielded syringe may be used for withdrawing and injecting the iodinated I 131 albumin.

Total Blood and Plasma Volumes Dosage may range from 5 to 50 microcuries. Blood Volume Determination A. Reference Solution Reference solution is provided with each single unit dose of Volumex.

Determine the radioactivity concentration (net cpm/mL) of the reference solution. Care must be taken to assure that the reference solution and the blood samples (Step B3) are assayed using the same geometric configuration. B.

Administration of Dose After withdrawing a background blood sample as described below, insert an intravenous (IV) line into a large vein in patient’s arm. Inject the entire Volumex dose (one milliliter) through the IV line for immediate delivery.Measure the residual radioactivity in the syringe and needle. Destroy syringe after injecting.

Do not attempt to resterilize. CAUTION: The syringe should be disposed of in accordance with the US Nuclear Regulatory Commission or Agreement State regulations pertaining to the disposal of radioactive waste. At 12, 18, 24, 30 and 36 minutes after injecting the dose, withdraw blood samples from the patient with a sterile syringe or evacuated sample tube containing anti-coagulant.

C. Calculation of Blood Volume 1. Take a known aliquot from each blood sample and determine radioconcentration in net cpm/mL.

2. Plot the 12, 18, 24, 30 and 36 minute sample counts (net cpm/mL) on semilog graph paper using the average count value of each sample and determine the radioconcentration at injection time (zero time) by drawing a straight line through the 12, 18, 24, 30 and 36 minute points to zero time. The x ordinate of the graph is the sample withdrawal time and the logarithmic y ordinate is radioconcentration in net cpm/mL.

3. Calculate patient’s blood volume (in mL) using the following formula: Net cpm/mL reference solution blood Net cpm/mL patient’s blood sample x DF = volume (in mL) Sample Blood Volume Calculations Volume of Blood sample aliquot = 1.0 mL Volume of Reference Solution aliquot = 1.0 mL Net counts at zero time = 48,100 Net counts obtained from reference solution aliquot = 52, 430 If, for example, DF, dilution factor of the reference solution = 4000 Using the above formula gives = 52,430 x 4000 = 4360 mL 48,100 Serial Blood Volume Determinations Iodinated I 131 Albumin Injection is administered in sufficiently low dosage to permit repetitions as often as required by clinical circumstances.

It must be remembered that it is always necessary to correct for background radioactivity remaining in the blood from former determinations. Therefore, f… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 3 words ▾

CONTRAINDICATIONS None known.

⚠️ Warnings 36 words ▾

WARNINGS A few instances of hyperpyrexia and aseptic (chemical) meningeal irritation have been reported with the use of iodinated I 131 albumin in cisternography. Iodinated I 131 Albumin Injection is not approved for use in cisternography.

🤒 Adverse Reactions 42 words ▾

ADVERSE REACTIONS Although the immunological properties of albumin human are believed to be virtually unaltered by the iodination process, there is a theoretical possibility that allergic reactions may occur in patients receiving additional doses a number of weeks after an initial dose.

🧬 Clinical Pharmacology 208 words ▾

CLINICAL PHARMACOLOGY Following intravenous injection, radioiodinated albumin human is uniformly distributed throughout the intravascular pool within 10 minutes; extravascular distribution takes place more slowly. Iodinated I 131 albumin also can be detected in the lymph and in certain body tissues within 10 minutes after injection, but maximum distribution of radioactivity throughout the extravascular space does not occur until two to four days after administration. The time at which extravascular activity is maximal has been designated as the “equilibrium time.” When this point has been reached, the radioactivity remaining in the intravascular and extravascular spaces decreases slowly and exponentially in parallel fashion.

The administered radioactivity is eliminated almost entirely in the urine, only about 2 percent of the total dose ultimately appearing in the feces. The biologic half-life of iodinated I 131 albumin is dependent upon a number of factors, and published studies have varied considerably in their reporting of this figure. It has ranged, in the literature, from below 10 days to over 20 days.

One important factor affecting the biologic half-life is the initial rate of excretion, and this depends in part on the quality of the iodinated I 131 albumin. With Volumex, the biologic half-life in normal individuals has been reported to be approximately 14 days.

📦 How Supplied / Storage and Handling 81 words ▾

HOW SUPPLIED Volumex (Iodinated I 131 Albumin Injection USP) is available in single unit dose syringes containing 25 microcuries of activity in one milliliter per syringe on the date of calibration. Each single unit dose syringe is supplied with reference solution. Complete assay data for each single unit dose syringe and reference solution are provided on their respective containers.

The maximum concentration of a single unit dose syringe of Volumex does not exceed 26.3 microcuries per milliliter at time of calibration

📦 Storage and Handling 7 words ▾

Storage Store in a refrigerator, 2-8°C (36-46°F)

📋 Description 118 words ▾

DESCRIPTION Volumex (Iodinated I 131 Albumin Injection) is a diagnostic radiopharmaceutical containing iodinated I 131 albumin for intravenous use. Each mL of sterile, nonpyrogenic, aqueous, colorless to very pale yellow solution provides approximately 10 mg protein (albumin human), 16 mg dibasic sodium phosphate, 1.6 mg monobasic sodium phosphate, not more, than 0.4 mg guanidine hydrochloride, sodium chloride for isotonicity, and 9 mg benzyl alcohol as a preservative. The stabilizer acetyltryptophanate and sodium caprylate have a concentration of less than 0.0089M.

The pH has been adjusted to 7.2-7.8 with sodium hydroxide or hydrochloric acid. Volumex was prepared from blood that was nonreactive when tested for hepatitis B surface antigen (HB s Ag). The structure of the complex is unknown.

⚠️ Precautions 215 words ▾

PRECAUTIONS General In the use of any radioactive material, care should be taken to insure minimum radiation exposure to the patient and occupational workers consistent with proper patient management. Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential or whether iodinated I 131 albumin affects fertility in males or females.

Pregnancy Category C Animal reproduction studies have not been conducted with Iodinated I 131 Albumin Injection. It is also not known whether this agent can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Iodinated I 131 Albumin Injection should be administered to a pregnant woman only if clearly needed.

Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses. Nursing Mothers Since iodine 131 is excreted in human milk during lactation, formula feedings should be substituted for breast feedings. Pediatric use Safety and effectiveness in children have not been established.

📄 Package Label / Principal Display Panel 2 words ▾

Packaging Volumex

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Volumex (this brand).

Top reported reactions

Headache1
Lacrimation Increased1
Nausea1

Reporter sex

2 reports
Female · 100%
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 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 Iso-Tex Diagnostics, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Iso-Tex Diagnostics, 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.
← 50909-9201-01 · Hovione 50914-7729-02 · Iso-Tex →
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.