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Glofil-125 Sodium Iothalamate I-125 injection .275 mCi/mL Injection, Solution — NDC 50914-7729-02 package photo

Glofil-125 Sodium Iothalamate I-125 injection .275 mCi/mL Injection, Solution

by Iso-Tex Diagnostics, Inc. · 1 VIAL, MULTI-DOSE in 1 BOX (50914-7729-2) / 4 mL in 1 VIAL, MULTI-DOSE
NDC 50914-7729-02
🏷️ FDA NDC (as labeled) 50914-7729-2 billing pads the package segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 50914-7729-2
Product NDC 50914-7729
11-digit billing NDC 50914772902
UNII 31J5U3Q9ZN
UPC 0050914772920
Application # NDA017279
SPL Set ID 7f250086-2837-484b-9674-e09856b34cb0
Established class (EPC) Radioactive Diagnostic Agent
Mechanism of action Radiopharmaceutical Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1983-05-01
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance IOTHALAMATE SODIUM I-125
GCN Seq No 000424
GCN 01573
HICL code 000149
Ingredient (HICL) Iothalamate Sodium
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A6
Therapeutic class — intermediate (HIC2) Cardiovascular Diagnostic Agents
HIC3 code A6U
Therapeutic class — specific (HIC3) Cardiovascular Diagnostics-Radiopaque
AHFS code 36:68.00.00
AHFS class Roentgenography And Other Imaging Agents
FDB label name GLOFIL 0.1% VIAL
FDB brand name Glofil
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 50914-7729-2 — 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 → 50914-7729-02. 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

LabelerIso-Tex Diagnostics, Inc.
Application holderISOTEX DIAGNOSTICS
FDA applicationNDA017279 (NDA)
Labeler code50914
First marketedMay 1983
Product typeHuman Prescription Drug
Portfolio3 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

Label name GLOFIL 0.1% VIAL Ingredient Iothalamate Sodium

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 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.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 8MDF5V39QO
    A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.

3 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.
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
Glofil-125 .275 mCi/mLthis 50914-7729-02 Iso-Tex 1 vial — — 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

🏛️
1983
On the market since
May 1983
📍
2026
Currently FDA-listed
43 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
50914-7729-02 You're viewing this 1 VIAL, MULTI-DOSE in 1 BOX (50914-7729-2) / 4 mL in 1 VIAL, MULTI-DOSE 1983-05-01 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 50914-7729-2, 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: 50914-7729-02, written without dashes as 50914772902. 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 50914-7729-02, the first segment (50914) is the labeler code FDA assigned to Iso-Tex Diagnostics, Inc.; the middle segment (7729) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 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.

📄 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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description
🎯 Indications and Usage 25 words ▾

INDICATIONS AND USAGE GLOFIL-125 (Sodium Iothalamate I-125 Injection) is indicated for evaluation of glomerular filtration in the diagnosis or monitoring of patients with renal disease.

⏱️ Dosage and Administration ~3 min read ▾

Dosage The suggested dose range employed in the average patient (70 kg) is as follows: Continuous intravenous infusion: 20 to 100 μCi (0.74-3.7 megabecquerels) (Sigman, et al (1) method). Single intravenous injection: 10 to 30 µCi (0.37-1.11 megabecquerels) Cohen, et al (2) method) The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. Technique Continuous intravenous infusion Sigman 1 method I.

Preparation: Adequate diuresis (a urine flow exceeding 3 mL/min.) is established, preferably by an oral water load of 1,500 mL two hours prior to the beginning of the clearance study. 2. It is not necessary to withhold breakfast or admit the patient the night before.

II. Procedure: After the establishment of adequate diuresis, a number 14 or 16 French Foley catheter is aseptically inserted into the bladder. An intravenous infusion of Lactated Ringers (Hartmanns) solution is started in each arm, one to maintain a site for injection of the GLOFIL-125, the other to serve as a site for serial withdrawal of blood.

A two-way stopcock connects the needle and intravenous tubing of each arm. The dose is equally divided into (1) an intravenous priming dose to be injected as is and (2) a sustaining dose to be diluted in 30 to 60 mL of isotonic sodium chloride, depending on how many collection periods are anticipated. The priming dose is slowly injected into one arm.

This is immediately followed by infusion of the sustaining solution through the same site, usually at the rate of 0.5 mL/min., by means of an automatic pump. During this infusion, the Lactated Ringers solution in the same arm is discontinued, and 40 to 45 minutes are allowed for equilibration in order to reach a state of constant plasma concentration of radioactivity. After attaining equilibrium, consecutive 15 minute collection periods are started.

From the arm opposite the injection site, 5 mL of blood (allowing duplicate plasma counting volumes) is drawn six minutes prior to the midpoint of each collection period, placed in heparinized tubes, mixed, and centrifuged. The blood samples may be obtained through the two-way stopcock after discarding the first 30 mL aspirated into the syringe. This 30 mL contains the contents of the tubing, including infusion fluid, and must be cleared in order to obtain an undiluted blood sample.

If desired, this step may be eliminated and blood samples obtained by direct venipuncture. During each collection period, total urine must be accurately collected and the volume accurately measured. Three such consecutive collection periods are sufficient for most clinical studies.

III. Clearance Calculations: 1. Aliquots (1 mL each) of plasma and urine from each collection period are counted in a standard gamma-ray scintillation well detector.

2. All counts are corrected for background activity. 3.

Glomerular filtration rate is calculated by the formula C=UV/P, in which: C = glomerular filtration rate in mL/min U= urinary concentration of radioactivity in net counts/min/mL V= urinary flow rate in mL/min P = plasma concentration of radioactivity in net counts/min/mL 4. Average glomerular filtration rate (GFR) is calculated from the rates for the individual collection periods. GFR can be expressed in terms of body weight (mL/min/kg) or body surface area (mL/min/m 2 ).

5. Unilateral glomerular filtration rates can be determined by the same technique by utilizing ureteral catheterization. Single intravenous injection Cohen 2 method: The method of Cohen, et al 2 requires little preparation, few and small blood samples, no bladder catheterization, and no constant intravenous infusion.

It is simple to perform, rapid, and utilizes equipment which is readily available in most modern laboratories. I. Preparation: 1.

Lugol's solution, 3 drops orally, three times a day, is administered for one or two days prior to the test. No diet or water restriction is necessary. 2.

Oral water load is begun one hour befor…

⛔ Contraindications 11 words ▾

CONTRAINDICATIONS GLOFIL-125 should not be administered via a central venous line.

⚠️ Warnings 3 words ▾

WARNINGS None known

🤒 Adverse Reactions 4 words ▾

ADVERSE REACTIONS None Reported

🧬 Clinical Pharmacology 40 words ▾

CLINICAL PHARMACOLOGY The renal clearance of sodium iothalamate in man closely approximates that of inulin. The compound is cleared by glomerular filtration without tubular secretion or reabsorption. Following infusion administration of I-125 iothalamate, the effective half-life is about 0.07 days.

📦 How Supplied / Storage and Handling 82 words ▾

HOW SUPPLIED Identity No. 1000, GLOFIL-125 is a clear, colorless, sterile, and nonpyrogenic solution available as a 4 mL vial. It is supplied in a concentration of approximately 1 mg/mL sodium iothalamate (range is 0.5–2.0 mg sodium iothalamate per mL), with a radioactivity concentration of 250 to 300 μCi/mL at the time of calibration.

Benzyl alcohol 0.9%, is added as a preservative. Sodium bicarbonate and hydrochloric acid are added for pH adjustment. The calibration and expiration dates are shown on the label.

📦 Storage and Handling 10 words ▾

Storage Refrigerate the product upon receipt at 2°C to 8°C.

📋 Description 53 words ▾

DESCRIPTION General GLOFIL-125 (Sodium Iothalamate I-125 Injection) is a sterile, nonpyrogenic aqueous injection containing approximately 1 mg sodium iothalamate per mL, and 0.9 percent benzyl alcohol as a preservative. The radioactive concentration of the material is 250-300 µCi/mL as of the calibration date. Sodium bicarbonate and hydrochloric acid are present for pH adjustment.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 50914-7720-08 · Iso-Tex 50914-7731-04 · 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.