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Gallium Ga-68 PSMA-11 GALLIUM GA-68 GOZETOTIDE 5 mCi/mL Injection, Solution, 11 mL — NDC 24275-0525-1 (Billing 24275-0525-01)

by UCSF Radiopharmaceutical Facility · 11 mL in 1 VIAL, MULTI-DOSE

This is a package of 11 mL of Gallium Ga-68 PSMA-11 GALLIUM GA-68 GOZETOTIDE 5 mCi/mL Injection, Solution from UCSF Radiopharmaceutical Facility, marketed since Dec 2020 and currently FDA-listed. It is this product's only package size.

NDC 24275-0525-01

🏷️ FDA NDC (as labeled) 24275-0525-1 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

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This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

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 24275-0525-1 alone.

Record: FDA NDC Directory package listing · Human prescription drug
Code segments: 24275 labeler · 0525 product · 1 package
Package marketed since: Dec 14, 2020
Sample package: No — commercial package
Listing certified through: Dec 31, 2026
Barcode (UPC-A, from the NDC): 3 2427505251 0
FDA record last changed: Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 24275-0525-1

Product NDC 24275-0525

11-digit billing NDC 24275052501

NCPDP billing unit EA — each (per item)

UNII ZJ0EKR6M10

Application # NDA212643

SPL Set ID b6253a7b-0f73-36be-e053-2a95a90a9015

Established class (EPC) Radioactive Diagnostic Agent

Mechanism of action Positron Emitting Activity

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2020-12-14

Route INTRAVENOUS

Dosage form INJECTION, SOLUTION

Substance GALLIUM GA-68 GOZETOTIDE

TE code (Orange Book) AP · RLD · RS

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

GPI-14 94356530302020

GPI class Gallium Ga 68 PSMA-11

GCN Seq No 081735

GCN 48934

HICL code 047013

Ingredient (HICL) Gallium Ga-68 Gozetotide

HIC1 code Z

Therapeutic class — broad (HIC1) Body As A Whole

HIC2 code Z5

Therapeutic class — intermediate (HIC2) Radiopharmaceuticals/Radiopharmaceutical Adjuvants

HIC3 code Z5B

Therapeutic class — specific (HIC3) Radiopharmaceuticals Elements

AHFS code 36:68.00.00

AHFS class Roentgenography And Other Imaging Agents

FDB label name GALLIUM GA-68 GOZETOTIDE VIAL

FDB brand name Gallium Ga-68 Gozetotide

Legend status F — Federal legend — prescription drug or device

Quick answers

GSN (GCN sequence number): 081735
GCN: 48934
GPI-14 (Medi-Span): 94356530302020
HICL (First Databank): 047013
AHFS class code: 36:68.00.00

Why two NDCs? The FDA registers this code as 24275-0525-1 — 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 → 24275-0525-01. 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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 3, 2026
RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
Medi-Span GPI (licensed)
First Databank (licensed) · refreshed Oct 1, 2026

Clinical

Label name GALLIUM GA-68 GOZETOTIDE VIAL Ingredient Gallium Ga-68 Gozetotide

Patient education

📘 MedlinePlus patient leaflet ↗

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.

MedlinePlus (NLM) · refreshed Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 3, 2026

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 system	Per mL	Per 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.

CMS NADAC weekly file
CMS ASP pricing files · refreshed Sep 20, 2026
CMS Medicaid State Drug Utilization Data · refreshed Oct 4, 2026
CMS Part D plan pricing files · refreshed Sep 24, 2026
VA National Acquisition Center price file

Packaging — all sizes for this product

Package NDC	Description	Marketing start	Marketing end	Status
24275-0525-01 You're viewing this Main listing	11 mL in 1 VIAL, MULTI-DOSE	2020-12-14	—	Active

Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Gallium Ga-68 PSMA-11 5 mCi/mL 76394-2642-03	UCLA	12 ml	—	—	FDA listed	—
Gallium Ga-68 PSMA-11 5 mCi/mLthis 24275-0525-01	UCSF	11 ml	—	AP	FDA listed	—
Gallium Ga-68 PSMA-11 5 mCi/mL 71162-0201-10	Ionetix	9 ml	—	AP	FDA listed	—

About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.

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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA Orange Book · refreshed Oct 3, 2026
CMS NADAC weekly file

Availability & generic status

🏛️

2020

On the market since

Dec 2020

📍

2026

Currently FDA-listed

6 years listed

🔒

Generic approved (availability unconfirmed)

see note

🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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.

FDA Orange Book · refreshed Oct 3, 2026

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 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in 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.

FDA label on DailyMed · label index refreshed Oct 3, 2026
FDA openFDA NDC Directory · synced Oct 1, 2026

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

LabelerUCSF Radiopharmaceutical Facility

Application holderUNIV OF CALIFORNIA SAN FRANCISCO

FDA applicationNDA212643 (NDA)

Labeler code24275

First marketedDec 2020

Product typeHuman Prescription Drug

Portfolio3 products on file

More NDCs from UCSF Radiopharmaceutical Facility labeler code 24275

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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.

FDA openFDA NDC Directory · synced Oct 1, 2026
Drugs@FDA

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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel

🎯 Indications and Usage 101 words ▾

1 INDICATIONS AND USAGE Gallium Ga 68 Gozeotide Injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Gallium Ga 68 Gozetotide Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Use appropriate aseptic technique and radiation safety handling measures to maintain sterility during all operations involved in the manipulation and administration of Gallium Ga 68 Gozetotide Injection. ( 2.1 ) The recommended adult dose is 111 MBq to 259 MBq (3 mCi to 7 mCi) as a bolus intravenous injection. ( 2.2 ) A diuretic expected to act within the uptake time period may be administered at the time of radiotracer injection.

( 2.2 ) Initiate imaging 50 to 100 minutes after administration. The patient should void immediately prior to initiation of imaging. Scan should begin caudally and proceed cranially.

( 2.4 ) See full prescribing information for additional preparation, administration, imaging, and radiation dosimetry information. ( 2 )

2.1Radiation Safety – Drug Handling Handle Gallium Ga 68 Gozetotide Injection with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions (5.2) ] . Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Gallium Ga 68 Gozetotide Injection. Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.

2.2Recommended Dosage and Administration Instructions Recommended Dosage In adults, the recommended amount of radioactivity to be administered for PET is 111 MBq to 259 MBq (3 mCi to 7 mCi) administered as an intravenous bolus injection. Administration Use aseptic technique and radiation shielding when withdrawing and administering Gallium Ga 68 Gozetotide Injection. Calculate the necessary volume to administer based on calibration time and required dose.

Inspect Gallium Ga 68 Gozetotide Injection visually for particulate matter and discoloration before administration. Do not use the drug if the solution contains particulate matter or is discolored. Gallium Ga 68 Gozetotide Injection may be diluted with sterile 0.9% Sodium Chloride Injection, USP.

Assay the final dose immediately before administration to the patient in a dose calibrator. After injection of Gallium Ga 68 Gozeotide Injection, administer an intravenous flush of sterile 0.9% Sodium Chloride Injection, USP to ensure full delivery of the dose. Dispose of any unused drug in a safe manner in compliance with applicable regulations.

Unless contraindicated, a diuretic expected to act within the uptake time period may be administered at the time of radiotracer injection to potentially decrease artifact from radiotracer accumulation in the urinary bladder and ureters.

2.3Patient Preparation Prior to PET Imaging Instruct patients to drink a sufficient amount of water to ensure adequate hydration prior to administration of Gallium Ga 68 Gozeotide Injection and to continue to drink and void frequently following administration to reduce radiation exposure, particularly during the first hour after administration [see Warnings and Precautions (5.2) ] .

2.4Image Acquisition Position the patient supine with arms above the head. Begin PET scanning 50 to 100 minutes after the intravenous administration of Gallium Ga 68 Gozetotide Injection. Patients should void immediately prior to image acquisition and that image acquisition should begin at the proximal thighs and proceed cranially to the skull base or skull vertex.

Adapt imaging technique according to the equipment used and patient characteristics in order to obtain the best image quality possible.

2.5Image Interpretation Gallium Ga 68 Gozetotide binds to prostate-specific membrane antigen (PSMA). Based on the intensity of the signals, PET images obtained using Gallium Ga 68 Gozetotide Injection indicate the presence of PSMA in tissues. Lesions should be considered suspicious if uptake is greater than physiologic upta… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 66 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: supplied as a clear, colorless solution in a 20 mL multiple-dose vial containing

18.5MBq/mL to 185 MBq/mL (0.5 mCi/mL to 5 mCi/mL) of Gallium Ga 68 Gozetotide at calibration time. Injection: clear, colorless solution in a multiple-dose vial containing

18.5MBq/mL to 185 MBq/mL (0.5 mCi/mL to 5 mCi/mL) Gallium Ga 68 Gozetotide at calibration time ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None None ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Risk for misdiagnosis: Gallium Ga 68 gozetotide uptake can be seen in a variety of tumor types and in non-malignant processes. Image interpretation errors can occur with gallium Ga 68 gozetotide PET. ( 5.1 ) Radiation risk: Ensure safe handling to protect patients and health care workers from unintentional radiation exposure. ( 2.1 , 5.2 )

5.1Risk for Misdiagnosis Image interpretation errors can occur with gallium Ga 68 gozetotide PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of Gallium Ga 68 Gozetotide Injection for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease [See Clinical Studies (14) ] .

The performance of Gallium Ga 68 Gozetotide Injection for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score [See Clinical Studies (14) ] . Gallium Ga 68 Gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget's disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

5.2Radiation Risks Gallium Ga 68 Gozetotide Injection contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and health care workers.

Advise patients to hydrate before and after administration and to void frequently after administration [see Dosage and Administration (2.1 , 2.3) ] .

🤒 Adverse Reactions 133 words ▾

6 ADVERSE REACTIONS The most commonly reported adverse reactions include nausea, diarrhea, and dizziness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact UCSF Nuclear Medicine at 1-888-919-0740 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. . Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of Gallium Ga 68 Gozetotide Injection was evaluated in 960 patients, each receiving one dose of Gallium Ga 68 Gozetotide Injection. The average injected activity was 188.7 ±

40.7MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%

🔄 Drug Interactions 60 words ▾

7 DRUG INTERACTIONS Androgen deprivation therapy and other therapies targeting the androgen pathway Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established.

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Gallium Ga 68 Gozetotide Injection is not indicated for use in females. There are no available data with Gallium Ga 68 Gozetotide Injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. All radiopharmaceuticals, including Gallium Ga 68 Gozetotide Injection, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.

Animal reproduction studies have not been conducted with gallium Ga 68 gozetotide Injection.

8.2Lactation Risk Summary Gallium Ga 68 Gozetotide Injection is not indicated for use in females. There are no data on the presence of gallium Ga 68 gozetotide in human milk, the effect on the breastfed infant, or the effect on milk production.

8.4Pediatric Use The safety and effectiveness of Gallium Ga 68 Gozetotide Injection have not been estabished in pediatric patients.

8.5Geriatric Use The efficacy of Gallium Ga 68 Gozetotide PET in geriatric patients with prostate cancer is based on data from two prospective studies [see Clinical Studies (14) ] . Of the total number of subjects in these studies of Gallium Ga 68 Gozetotide Injection, 691 of 960 (72%) were 65 years of age and older. The efficacy and safety profies of Gallium Ga 68 Gozetotide Injection appear similar in younger adult and geriatric patients with prostate cancer, althougth the number of younger adult patients in the trials was not large enought to allow definitive comparisons.

🤰 Pregnancy 90 words ▾

Animal reproduction studies have not been conducted with gallium Ga 68 gozetotide Injection.

🧒 Pediatric Use 20 words ▾

8.4Pediatric Use The safety and effectiveness of Gallium Ga 68 Gozetotide Injection have not been estabished in pediatric patients.

🧓 Geriatric Use 97 words ▾

🆘 Overdosage 62 words ▾

10 OVERDOSAGE In the event of an overdose of Gallium Ga 68 Gozetotide Injection, reduce the radiation absorbed dose to the patient where possible by increasing the elimination of the drug from the body using hydration and frequent bladder voiding. A diuretic might also be considered. If possible, an estimate of the radiation effective dose given to the patient should be made.

🧬 Clinical Pharmacology 147 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Gallium Ga 68 gozetotode binds to prostate-specific membrane antigen (PSMA). It binds to cells that express PSMA, including malignant prostate cancer cells, which usually overexpress PSMA. Gallium-68 (Ga 68) is a β+ emitting radionuclide that allows positron emission tomography (PET).

12.2Pharmacodynamics The relationship between galium Ga 68 gozetotide plasma concentrations and successful imaging was not explored in clinical trials.

12.3Pharmacokinetics Distribution Intravenously injected gallium Ga 68 gozetotide is cleared from the blood and is accumulated preferentially in the liver (15%), kidneys (7%), spleen (2%), and salivary glands (0.5%). Gallium Ga 68 gozetotide uptake is also seen in the adrenals and prostate. There is no uptake in the cerebral cortex or in the heart, and usually lung uptake is low.

Elimination A total of 14% of the injected dose is excreted in urine in the first 2 hours post-injection.

🧬 Mechanism of Action 44 words ▾

📦 How Supplied / Storage and Handling 157 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Gallium Ga 68 Gozetotide Injection (NDC 24275-0525-1) is a clear, colorless solution, supplied in a capped glass vial containing

18.5MBq/mL to 185 MBq/mL (0.5 mCi/mL to 5 mCi/mL) of gallium Ga 68 gozetotide at end of synthesis, in approximately 11 mL. The contents of each vial are sterile, pyrogen-free and preservative-free. The expiration date and time are provided on the container label.

Use Gallium Ga 68 Gozetotide Injection within 4 hours of calibration time. Storage and Handling Storage Store Gallium Ga 68 Gozetotide Injection upright in a lead shielded container at 25°C (77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F). Store Gallium Ga 68 Gozetotide Injection within the original container in radiation shielding.

Handling Receipt, transfer, handling, possession, or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States, or Licensing States as appropriate.

📦 Storage and Handling 75 words ▾

Storage and Handling Storage Store Gallium Ga 68 Gozetotide Injection upright in a lead shielded container at 25°C (77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F). Store Gallium Ga 68 Gozetotide Injection within the original container in radiation shielding. Handling Receipt, transfer, handling, possession, or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S.

Nuclear Regulatory Commission, Agreement States, or Licensing States as appropriate.

📋 Description ~1 min read ▾

11 DESCRIPTION

11.1Chemical Characteristics Gallium Ga Gozetotide Injection is a radioactive diagnostic agent for intravenous administration. It contains 0.5 mcg/mL Gozetotide,

18.5MBq/mL to 185 MBq/mL (0.5 mCi/mL to 5 mCi/mL) of gallium Ga gozetotide at calibration time in 0.9% sodium chloride solution with not more than 10% ethanol (approximately 11 mL total volume). Gallium Ga Gozetotide Injection is provided as a sterile, pyrogen free, clear, colorless solution for intravenous use, with a pH between 4.0 and 7.0. Gozetotide is also known as PSMA-11.

Gallium Ga Gozetotide is a urea based peptidomimetic that has a covalently bound chelator (HBED-CC). The peptide has the amino acid sequence Glu-NH-CO-NH-Lys(Ahx)-HBED-CC. Gallium Ga Gozeotide has a molecular weight of 1011.91 g/mol and its chemical structure is shown in Figure 1.

Figure 1: Chemical Structure of Gallium Ga Gozetotide Chemical Structure

11.2Physical Characteristics Gallium-68 (Ga 68) decays with a half-life of 68 minutes to stable zinc-68. Table 2 and Table 3 display the principle radiation emission data and physical decay of Ga 68. Table 2: Principal Radiation Emission Data (>1%) for Gallium Ga 68 Radiation/ Emission % Disintegration Mean Energy (MeV) beta+ 88% 0.8360 beta+ 1.1% 0.3526 gamma 178% 0.5110 gamma 3.0% 1.0770 X-ray 2.8% 0.0086 X-ray 1.4% 0.0086 Table 3: Physical Decay Chart for Gallium Ga 68 Minutes Fraction Remaining 0 1 15 0.858 30 0.736 60 0.541 90 0.398 120 0.293 180 0.158 360 0.025

11.3External Radiation Table 4 displays the radiation attenuation by lead shielding of Ga 68. Table 4: Radiation Attenuation of 511 keV Photons by Lead (Pb) Shielding Shield Thickness (Pb) mm Coefficient of Attenuation 6 0.5 12 0.25 17 0.1 34 0.01 51 0.001

💬 Information for Patients 65 words ▾

17 PATIENT COUNSELING INFORMATION Adequate Hydration Instruct patients to drink a sufficient amount of water to ensure adequate hydration before their PET study and urge them to drink and urinate as often as possible during the first hours following the administration of Gallium Ga 68 Gozetotide Injection, in order to reduce radiation exposure [see Dosage and Administration (2.3) and Warnings and Precautions (5.2) ] .

🧬 Pharmacokinetics 80 words ▾

Elimination A total of 14% of the injected dose is excreted in urine in the first 2 hours post-injection.

🧬 Pharmacodynamics 20 words ▾

12.2Pharmacodynamics The relationship between galium Ga 68 gozetotide plasma concentrations and successful imaging was not explored in clinical trials.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The safety and efficacy of Gallium Ga 68 Gozetotide Injection were established in two prospective, open-label studies, PSMA-PreRP (NCT03368547 and NCT02919111) and PSMA-BCR (NCT02940262 and NCT02918357), in men with prostate cancer. PSMA-PreRP This two-center study enrolled 325 patients with biopsy-proven prostate cancer who were considered candidates for prostatectomy and pelvic lymph node dissection. All enrolled patients met at least one of the following criteria: serum prostate-specific antigen (PSA) of at least 10 ng/mL, tumor stage cT2b or greater, or Gleason score greater than 6.

Each patient received a single gallium Ga 68 gozetotide PET/CT or PET/MR from mid-thigh to skull base. A total of 123 patients (38%) proceeded to standard-of-care prostatectomy and template pelvic lymph node dissection and had sufficient histopathology data for evaluation (evaluable patients). Three members of a pool of six central readers independently interpreted each PET scan for the presence of abnormal gallium Ga 68 gozetotide uptake in pelvic lymph nodes located in the common iliac, external iliac, internal iliac, and obturator subregions bilaterally as well as in any other pelvic location.

The readers were blinded to all clinical information except for the history of prostate cancer prior to definitive treatment. Extrapelvic sites and the prostate gland itself were not analyzed in this study. For each patient, gallium Ga 68 gozetotide PET results and reference standard histopathology obtained from dissected pelvic lymph nodes were compared by region (left hemipelvis, right hemipelvis, and other).

For the 123 evaluable patients, the mean age was 65 years (range 45 to 76 years), and 89% were white. The median serum PSA was 11.8 ng/mL. The summed Gleason score was 7 for 44%, 8 for 20%, and 9 for 31% of the patients, with the remainder of the patients having Gleason scores of 6 or 10.

Table 5 compares majority PET reads to pelvic lymph node histopathology results at the patient-level with region matching, such that at least one true positive region defines a true positive patient. As shown, approximately 24% of subjects studied were found to have pelvic nodal metastases based on histopathology (95% confidence interval: 17%, 32%). Table 5: Patient-Level Performance of Ga 68 PSMA-11 PET for Detection of Pelvic Lymph Node Metastasis with region matching where at least one true positive region defines a true positive patient in the PSMA-PreRP Study (n=123) Histopathology Predictive value (95% CI) PPV: positive predictive value, NPV: negative predictive value Positive Negative PET scan Positive 14 9 PPV 61% (41%, 81%) Negative 16 84 NPV 84% (79%, 91%) Total 30 93 Diagnostic performance (95% CI) Sensitivity 47% (29%, 65%) Specificity 90% (84%, 96%) Among the pool of six readers, sensitivity ranged from 36% to 60%, specificity from 83% to 96%, positive predictive value from 38% to 80%, and negative predictive value from 80% to 88%.

In an exploratory subgroup analysis based on summed Gleason score, there was a numerical trend toward more true positives in patients with Gleason score of 8 or higher compared to those with Gleason score of 7 or lower. An exploratory analysis was performed to estimate the sensitivity and specificity for pelvic nodal metastasis detection in all scanned patients, including the patients who were lacking histopathology reference standard. An imputation method was used based on patient-specific factors.

This exploratory analysis resulted in an imputed sensitivity of 47%, with a 95% confidence interval ranging from 38% to 55%, and an imputed specificity of 74%, with a 95% confidence interval ranging from 68% to 80% for all patients imaged with gallium Ga 68 gozetotide PET. PSMA-BCR This two-center study enrolled 635 patients with biochemical evidence of recurrent prostate cancer after definitive therapy, defined by serum PSA of >0.2 ng/mL more than 6 weeks after prostatectomy or by an increase in serum PSA… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 25 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies were performed to evaluate the carcinogenicity potential of gallium Ga 68 gozetotide.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 22 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies were performed to evaluate the carcinogenicity potential of gallium Ga 68 gozetotide.

📄 Package Label / Principal Display Panel 15 words ▾

Drug Product Label Vial and Radiation Shield PRINCIPAL DISPLAY PANEL -

18.5 MBq/mL Vial Label

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

bolus: A single dose given all at once, often as a quick push into a vein.

Carcinogenesis, Mutagenesis, Impairment of Fertility: A label section reporting whether lab or animal studies found effects on cancer risk, genes, or the ability to have children.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

confidence interval: A range of numbers that likely contains the true result, showing how sure researchers can be about a study's finding.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

fertility: The natural ability to become pregnant or to father a child.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

lactation: The making and release of milk from a mother's breasts after giving birth.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

metastasis: The spread of cancer from where it first started to other parts of the body.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Nonclinical Toxicology: The label section summarizing safety findings from laboratory and animal studies, rather than from studies in people.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

subgroup analysis: A closer look at results within a smaller part of a study, such as one age or sex, to see if the effect differs.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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 Gallium Ga-68 PSMA-11 (this brand).

Top reported reactions

Hot Flush35

Erectile Dysfunction24

Fatigue14

Death11

Overdose9

Pathological Fracture9

Rash8

Age at onset

Adult27

Elderly65

Reporter sex

Male · 100%

Reports over time (by year) — tap or hover for the count & year

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.

FDA Adverse Event Reporting System (FAERS)

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	✓ Available
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 UCSF Radiopharmaceutical Facility. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

UCSF Radiopharmaceutical Facility 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.

← 24275-0385-01 · UCSF 24286-0253-04 · DLC →

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.

Gallium Ga-68 PSMA-11 GALLIUM GA-68 GOZETOTIDE 5 mCi/mL Injection, Solution, 11 mL — NDC 24275-0525-1 (Billing 24275-0525-01)

NDC database record

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

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

Clinical

Patient education

Supplement & herbal interactions

Pricing

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Therapeutic equivalents

Availability & generic status

Inactive Ingredients / Excipients

Inactive ingredient FAQ

Manufacturer & labeler

More NDCs from UCSF Radiopharmaceutical Facility labeler code 24275

Full prescribing information FDA SPL

8 USE IN SPECIFIC POPULATIONS

12 CLINICAL PHARMACOLOGY

11 DESCRIPTION

13 NONCLINICAL TOXICOLOGY

18.5 MBq/mL Vial Label

Reported adverse events (FAERS)

Top reported reactions

Age at onset

Reporter sex

About this NDC listing & data coverage

Questions about this listing

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