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Indium DTPA In 111 Indium In-111 Pentetate Disodium 1 mCi/mL Solution, 1.5 mL — NDC 17156-251-08 (Billing 17156-0251-08)

by Medi-Physics, Inc. dba GE Healthcare · 1.5 mL in 1 VIAL, GLASS

This is a package of 1.5 mL of Indium DTPA In 111 Indium In-111 Pentetate Disodium 1 mCi/mL Solution from Medi-Physics, Inc. dba GE Healthcare, marketed since Feb 1982 and currently FDA-listed. It is this product's only package size.

NDC 17156-0251-08
🏷️ FDA NDC (as labeled) 17156-251-08 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 →

NDC database record

One package, one record: these facts belong to NDC 17156-251-08 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
17156 labeler · 251 product · 08 package
Package marketed since
Feb 18, 1982
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 1715625108 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 17156-251-08
Product NDC 17156-251
11-digit billing NDC 17156025108
NCPDP billing unit EA — each (per item)
UNII 7UIT3ZGC8E
Application # NDA017707
SPL Set ID 4fea5871-b515-4f69-a297-11507ddd7817
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 1982-02-18
Route INTRATHECAL
Dosage form SOLUTION
Substance INDIUM IN-111 PENTETATE DISODIUM

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

GPI-14 94354040702000
GPI class Indium In 111 DTPA
GCN Seq No 051788
GCN 19157
HICL code 025010
Ingredient (HICL) Pentetate Indium Disod. In-111
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H1
Therapeutic class — intermediate (HIC2) Drugs Affecting Principally The Brain
HIC3 code H1V
Therapeutic class — specific (HIC3) Cerebral Spinal Radioactive Diagnostics
AHFS code 36:00.00.00
AHFS class Diagnostic Agents
FDB label name INDIUM IN-111 DTPA SOLUTION
FDB brand name Indium In-111 Dtpa
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 051788
  • GCN: 19157
  • GPI-14 (Medi-Span): 94354040702000
  • HICL (First Databank): 025010
  • AHFS class code: 36:00.00.00
Why two NDCs? The FDA registers this code as 17156-251-08 — 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 → 17156-0251-08. 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 INDIUM IN-111 DTPA SOLUTION Ingredient Pentetate Indium Disod. In-111
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
17156-0251-08 You're viewing this Main listing 1.5 mL in 1 VIAL, GLASS 1982-02-18 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Indium DTPA In 111 1 mCi/mLthis 17156-0251-08 Medi-Physics, 1.5 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

🏛️
1982
On the market since
Feb 1982
📍
2026
Currently FDA-listed
44 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.

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

  • UNII 7A314HQM0I
    Pentetic acid is a chelating agent, a chemical that binds to metals. It's used in some medicines to prevent metal ions from interfering with drug stability or effectiveness.
  • 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.

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

LabelerMedi-Physics, Inc. dba GE Healthcare
Application holderGE HEALTHCARE
FDA applicationNDA017707 (NDA)
Labeler code17156
First marketedFeb 1982
Product typeHuman Prescription Drug
Portfolio2 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.

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 15 words ▾

INDICATIONS AND USAGE Pentetate Indium Disodium In 111 is recommended for use in radionuclide cisternography.

⏱️ Dosage and Administration 68 words ▾

DOSAGE AND ADMINISTRATION Extreme care must be exercised to assure aseptic conditions in intrathecal injections. The maximum recommended intrathecal dose in the average patient (70 kg) is

18.5MBq, 500 µ Ci. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

⛔ Contraindications 3 words ▾

CONTRAINDICATIONS None known.

⚠️ Warnings 38 words ▾

WARNINGS The contents of the vial are radioactive. Adequate shielding of the preparation must be maintained at all times. Since the drug is excreted by the kidneys, caution should be exercised in patients with severely impaired renal function.

🤒 Adverse Reactions 89 words ▾

ADVERSE REACTIONS Aseptic meningitis and pyrogenic reactions have been rarely (less than 0.4%) observed following cisternography with Pentetate lndium Disodium In 111. One death has been reported to have occurred within 20 minutes following the administration of Pentetate Indium Disodium In 111 and appears to be drug related. In addition, two cases of septic meningitis have also been reported.

There have also been reports of skin reactions and vomiting following administration of Pentetate lndium Disodium In 111. Relationship of the drug to these latter occurrences has not been established.

🤰 Pregnancy 91 words ▾

Pregnancy Category C Animal reproduction studies have not been conducted with GE Healthcare (Medi-Physics, Inc.) Indium DTPA In 111. Also, it is not known whether Pentetate Indium Disodium In 111 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pentetate Indium Disodium In 111 should be given 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.

🧒 Pediatric Use 12 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 141 words ▾

Geriatric use Clinical studies of Indium DTPA In 111 did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

The drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

🧬 Clinical Pharmacology 185 words ▾

CLINICAL PHARMACOLOGY After intrathecal administration, the radiopharmaceutical is absorbed from the subarachnoid space as described below, and the remainder flows superiorly to the basal cisterns within 2 to 4 hours and subsequently will be apparent in the Sylvian cisterns, the interhemispheric cisterns, and over the cerebral convexities. In normal individuals, the radiopharmaceutical will have ascended to the parasagittal region within 24 hours with simultaneous partial or complete clearance of activity from the basal cisterns and Sylvian regions.

In contrast to air, the radiopharmaceutical does not normally enter the cerebral ventricles. Although the primary absorption of cerebrospinal fluid (CSF) into the blood stream occurs at the arachnoid villi, there is some evidence that a significant fraction of CSF is also absorbed across both the cerebral and spinal leptomeninges. Lesser quantities may also be absorbed across the ventricular ependyma.

It is also generally held that these alternate routes of CSF absorption may assume primary importance when the major routes of the flow are pathologically obstructed. Approximately 65% of the administered dose is excreted by the kidneys within 24 hours and this increases to 85% in 72 hours.

📦 How Supplied / Storage and Handling 146 words ▾

HOW SUPPLIED Pentetate Indium Disodium In 111 (no-carrier-added) is supplied in single-dose glass vials, each containing 1.5 mL of solution with a concentration of 37 MBq, 1 mCi per mL and a total activity of

55.5MBq, 1.5 mCi per vial at calibration time. Vials are packaged in individual lead shields with plastic outer containers. NDC 17156-251-08 Storage Store vial in its lead shield at a temperature of 5°-30°C (41°-86°F).

Do not freeze. Disposal The residual materials may be discarded in ordinary trash provided the vials and syringes read no greater than background with an appropriate low-range survey meter. All identifying labels should be destroyed before discarding.

This radiopharmaceutical is licensed by Illinois Emergency Management Agency for distribution to persons licensed pursuant to 32 III. Adm. Code 330.260(a) and Part 335, Subpart E, 335.4010, or under equivalent licenses of an Agreement State or a Licensing State.

📦 Storage and Handling 16 words ▾

Storage Store vial in its lead shield at a temperature of 5°-30°C (41°-86°F). Do not freeze.

📋 Description ~2 min read ▾

DESCRIPTION GE Healthcare (Medi-Physics, Inc.) Indium DTPA In 111 is a diagnostic drug for intrathecal use. It is available as a sterile, pyrogen-free, isotonic, aqueous solution, buffered to pH 7 to 8. At calibration time, each milliliter contains 37 MBq, 1 mCi of Pentetate Indium Disodium In 111 (no-carrier-added), 20 to 50 µ g of pentetic acid, and sodium bicarbonate for pH adjustment.

The drug is to be discarded after single use. Radionuclidic purity at calibration time is at least 99.88% with less than 0.06% Indium In 114m and 0.06% Zinc Zn 65. The concentration of each radionuclidic contaminant changes with time.

Graph 1 shows maximum concentration of each radionuclidic impurity as a function of time. Graph 1 - Radionuclidic Impurities The chemical names are 1. Indate(2-)- 111 In -[ N,N -bis[2-[bis-(carboxymethyl)amino]ethyl]glycinato(5-)]-disodium; and 2.

Disodium [ N,N -bis[2-(carboxymethyl)amino]glycinato(5-)]-indate (2-) 111 In. Molecular formula: C 14 H 18 O 10 N 3 111 In Na 2 Molecular weight: 545.29 Structural formula: PHYSICAL CHARACTERISTICS Indium 111 decays by electron capture with a physical half-life of 67.9 hours. The energies of the photons that are useful for detection and imaging studies are listed in Table 1.

Table 1. Principal Radiation Emission Data Kocher, David C.,"Radioactive Decay Data Tables,"DOE/TIC-11026, 115, (1981). Radiation Mean %/Disintegration Mean Energy (keV) Gamma-2 90.2 171.3 Gamma-3 94.0 245.4 EXTERNAL RADIATION The specific gamma ray constant for Indium In 111 is

3.3R/hr-mCi at 1 cm. The half-value thickness of lead (Pb) for Indium In 111 is 0.021 cm. To facilitate control of the radiation exposure from millicurie amounts of this radionuclide, a range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2.

For example, the use of a 0.8 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000. Table 2. Radiation Attenuation by Lead Shielding Shield Thickness (Pb) cm Coefficient of Attenuation To correct for physical decay of this radionuclide, the fractions that remain at selected time intervals after the time of calibration are shown in Table 3.

0.021 0.5 0.19 10 -1 0.49 10 -2 0.80 10 -3 1.1 10 -4 Table 3. Physical Decay Chart: Indium In 111, Half-Life

67.9Hours Hours Fraction Remaining Hours Fraction Remaining 0 Calibration Time 1.000 84 0.424 12 0.885 96 0.375 24 0.783 108 0.332 36 0.693 120 0.294 48 0.613 132 0.260 60 0.542 144 0.230 72 0.480 168 0.180 Graph 1 Structural formula

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Pentetate Indium Disodium In 111, as well as other radioactive drugs, must be handled with care and appropriate safety measures should be used to minimize external radiation exposure to clinical personnel, and to minimize radiation exposure to patients 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.

Do not use after the expiration time and date (7 days after calibration time and date stated on the label). Discard vial after a single use. Do not use if contents are turbid.

Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential, or whether Pentetate lndium Disodium In 111 affects fertility in males or females. Pregnancy Category C Animal reproduction studies have not been conducted with GE Healthcare (Medi-Physics, Inc.) Indium DTPA In 111. Also, it is not known whether Pentetate Indium Disodium In 111 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Pentetate Indium Disodium In 111 should be given 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 It is not known whether this drug is excreted in human milk.

Because many drugs are excreted in human milk, formula feedings should be substituted for breast feedings when Pentetate Indium Disodium In 111 is administered to a nursing mother. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric use Clinical studies of Indium DTPA In 111 did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. The drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

🍼 Nursing Mothers 42 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, formula feedings should be substituted for breast feedings when Pentetate Indium Disodium In 111 is administered to a nursing mother.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 31 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential, or whether Pentetate lndium Disodium In 111 affects fertility in males or females.

📄 Package Label / Principal Display Panel 68 words ▾

PRINCIPAL DISPLAY PANEL - 1.5 mL Vial Label GE Healthcare Indium DTPA In 111 Pentetate Indium Disodium In 111 Sterile, Nonpyrogenic, Aqueous Solution for Intrathecal Injection DISCARD AFTER SINGLE USE. DO NOT USE IF CONTENTS ARE TURBID. VOLUME: 1.5 mL SPECIFIC CONCENTRATION: 37 MBq/mL (1 mCi/mL) TOTAL ACTIVITY:

55.5MBq (1.5 mCi) CALIB. DATE: TIME: 1200 LOT NO.: 2051 – Principal Display Panel - 1.5 mL Vial Label

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 Indium DTPA In 111 (this brand).

Top reported reactions

Radioisotope Scan Abnormal3
False Positive Investigation Result2
Meningitis1

Reporter sex

14 reports
Male · 50%
Female · 50%
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 4 0
Most recent year is provisional (FAERS lags ~3 months).
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 — Not published for this NDC No photo available yet for this listing.
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 Medi-Physics, Inc. dba GE Healthcare. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Medi-Physics, Inc. dba GE Healthcare 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.
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.