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GALLIUM CITRATE GA-67 2 mCi/mL Injection, Solution, 1 vial — NDC 69945-0180-12 package photo

GALLIUM CITRATE GA-67 2 mCi/mL Injection, Solution, 1 vial

by Curium US LLC · 1 VIAL in 1 CAN (69945-180-12) / 6.6 mL in 1 VIAL
NDC 69945-0180-12
🏷️ FDA NDC (as labeled) 69945-180-12 billing pads the product segment with a zero
This package
Contains1 vial Pack sizes2 compare ↓
Also comes in: 3.3 mL 69945-0180-06
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) 69945-180-12
Product NDC 69945-180
11-digit billing NDC 69945018012
UNII A04B19O2B0
Application # NDA018058
SPL Set ID 5f670c12-cca5-4d73-8a88-241f753d1bc7
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2008-02-21
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance GALLIUM CHLORIDE GA-67
GCN Seq No 062813
GCN 98584
HICL code 024487
Ingredient (HICL) Gallium-67 Citrate
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 CITRATE GA-67 74MBQ/ML
FDB brand name Gallium Citrate Ga-67
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) BS · RLD · RS
Why two NDCs? The FDA registers this code as 69945-180-12 — 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 → 69945-0180-12. 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

LabelerCurium US LLC
Application holderCURIUM US LLC
FDA applicationNDA018058 (NDA)
Labeler code69945
First marketedFeb 2008
Product typeHuman Prescription Drug
Portfolio34 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 GALLIUM CITRATE GA-67 74MBQ/ML Ingredient Gallium-67 Citrate

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 3.3 mL
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gallium Citrate Ga-67 2 mCi/mLthis 69945-0180-12 Curium 1 vial — BS 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

🏛️
2008
On the market since
Feb 2008
📍
2026
Currently FDA-listed
18 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
69945-0180-06 1 VIAL in 1 CAN (69945-180-06) / 3.3 mL in 1 VIAL 2008-02-21 Active
69945-0180-12 You're viewing this 1 VIAL in 1 CAN (69945-180-12) / 6.6 mL in 1 VIAL 2008-02-21 Active

Pack size FAQ

What quantity is in NDC 69945-0180-12?
NDC 69945-0180-12 contains 1 vial — 1 vial in 1 can / 6.6 ml in 1 vial.
What is the difference between NDC 69945-0180-12 and NDC 69945-0180-06?
Both are GALLIUM CITRATE GA-67 2 mCi/mL Injection, Solution — the drug itself is identical. NDC 69945-0180-12 is the 1 vial package, while NDC 69945-0180-06 is the 1 vial package.
What NDC number is used to bill for this package of GALLIUM CITRATE GA-67 2 mCi/mL Injection, Solution?
Bill NDC 69945-0180-12 — the 11-digit billing format is 69945018012. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 FDA registers it as 69945-180-12, 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: 69945-0180-12, written without dashes as 69945018012. 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 69945-0180-12, the first segment (69945) is the labeler code FDA assigned to Curium US LLC; the middle segment (0180) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (12) 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 Curium US LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 vial (69945-0180-06). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Curium US LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description
🎯 Indications and Usage 61 words ▾

INDICATIONS AND USAGE Gallium Citrate Ga 67 Injection may be useful to demonstrate the presence and extent of Hodgkin's disease, lymphoma, and bronchogenic carcinoma. Positive gallium Ga-67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state. Gallium Citrate Ga 67 Injection may be useful as an aid in detecting some acute inflammatory lesions.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION The recommended adult (70 kg) dose of Gallium Citrate Ga 67 Injection is 74 to 185 megabecquerels (2 to 5 millicuries). Gallium Citrate Ga 67 Injection is intended for intravenous administration only. Approximately 10 percent of the administered dose is excreted in the feces during the first week after injection.

Daily laxatives and/or enemas are recommended from the day of injection until the final images are obtained in order to cleanse the bowel of radioactive material and minimize the possibility of false positive studies. Studies indicate the optimal tumor to background concentration ratios are often obtained 48 hours post injection. However, considerable biological variability may occur in individuals and acceptable images may be obtained as early as 6 hours and as late as 120 hours after injection.

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. Do not use if contents are turbid.

Instructions for the handling of Gallium Citrate Ga 67: Waterproof gloves should be used during the entire handling and administration procedure. Using proper shielding, the vial containing the Gallium Citrate Ga 67 should be visually inspected to ensure that it is free of particulate matter and discoloration prior to use. Maintain adequate shielding during the life of the product and use a sterile, shielded syringe for withdrawing and injecting the preparation.

R adiation Dosimetry The estimated absorbed radiation doses 2 from an intravenous injection of 185 megabecquerels (5 millicuries) of Gallium Citrate Ga 67 are shown in Table 4. Table 4. Absorbed Radiation Doses Tissue mGy/ 185MBq rads/ 5mCi Whole Body Skeleton Liver Bone Marrow Spleen Kidney Ovaries Testes Gastrointestinal Tract Stomach Small Intestine Upper Large Intestine Lower Large Intestine 13.0 22.0 23.0 29.0 26.5 20.5 14.0 12.0 11.0 18.0 28.0 45.0 1.30 2.20 2.30 2.90 2.65 2.05 1.40 1.20 1.10 1.80 2.80 4.50 2 MIRD Dose Estimate Report No.

2, J. Nucl. Med.

14; 755-6 (1973).

⛔ Contraindications 2 words ▾

CONTRAINDICATIONS None.

⚠️ Warnings 3 words ▾

WARNINGS None known.

🤒 Adverse Reactions 22 words ▾

ADVERSE REACTIONS Rare occurrences of allergic reactions, skin rash and nausea have been reported in association with Gallium Citrate Ga 67 use.

🤰 Pregnancy 82 words ▾

Pregnancy Animal reproductive studies have not been conducted with Gallium Citrate Ga 67. It is also not known whether Gallium Citrate Ga 67 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Gallium Citrate Ga 67 should be given to a pregnant woman only if clearly needed.

Ideally, examinations using radiopharmaceuticals, especially those elective in nature of women of childbearing capability, should be performed during the first few (approximately ten) days following the onset of menses.

🧒 Pediatric Use 17 words ▾

Pediatric Use Safety and effectiveness in pediatric patients below the age of 18 have not been established.

🧬 Clinical Pharmacology 143 words ▾

CLINICAL PHARMACOLOGY Gallium Citrate Ga 67, with no carrier added, has been found to concentrate in certain viable primary and metastatic tumors as well as focal sites of infection. The mechanism of concentration is unknown, but investigational studies have shown that gallium Ga-67 accumulates in lysosomes and is bound to a soluble intracellular protein. It has been reported in the scientific literature that following intravenous injection, the highest tissue concentration of gallium Ga-67 - other than tumors and sites of infection - is the renal cortex.

After the first day, the maximum concentration shifts to bone and lymph nodes and after the first week, to liver and spleen. Gallium Ga-67 is excreted relatively slowly from the body. The average whole body retention is 65 percent after seven days, with 26 percent having been excreted in the urine and 9 percent in the stools.

📦 How Supplied / Storage and Handling 210 words ▾

HOW SUPPLIED Catalog Number 180. Gallium Citrate Ga 67 Injection is supplied sterile and non-pyrogenic for intravenous use. Each milliliter contains 74 megabecquerels (2 millicuries) of gallium Ga-67 on the calibration date, as a complex formed from 8.3 nanograms gallium chloride Ga-67, 1.9 milligrams of sodium citrate dihydrate, 7.8 milligrams of sodium chloride, and 0.9 percent benzyl alcohol (v/v) as a preservative.

The pH is adjusted to between 5.5 to 8.0 with hydrochloric acid and/or sodium hydroxide solution. Gallium Citrate Ga 67 Injection is available in vials containing the following amounts on the calibration date. Catalog No.

N180G0 222 megabecquerels (6 mCi) NDC 69945-180-06 N180M0 444 megabecquerels (12 mCi) NDC 69945-180-12 Storage and Handling The contents of the vial are radioactive, and adequate shielding and handling precautions must be maintained. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Storage and disposal of Gallium Citrate Ga 67 Injection should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide. ©2022 Curium US LLC.

Curium TM and the Curium logo are trademarks of a Curium company. Manufactured by: Curium US LLC Maryland Heights, MO 63043 Made in USA A180I0 R07/2022 Curium logo

📦 Storage and Handling 99 words ▾

Storage and Handling The contents of the vial are radioactive, and adequate shielding and handling precautions must be maintained. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Storage and disposal of Gallium Citrate Ga 67 Injection should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide. ©2022 Curium US LLC.

Curium TM and the Curium logo are trademarks of a Curium company. Manufactured by: Curium US LLC Maryland Heights, MO 63043 Made in USA A180I0 R07/2022 Curium logo

📋 Description ~2 min read ▾

DESCRIPTION Gallium Citrate Ga 67 Injection is supplied in a 10 milliliter vial as an isotonic, sterile, non-pyrogenic solution. Each milliliter of the isotonic solution contains 74 megabecquerels (2 millicuries) of gallium Ga-67 on the calibration date as a complex formed from 8.3 nanograms gallium chloride Ga-67, 1.9 milligrams of sodium citrate dihydrate, 7.8 milligrams of sodium chloride and 0.9 percent benzyl alcohol (v/v) as a preservative. The pH is adjusted to between 5.5 to 8.0 with hydrochloric acid and/or sodium hydroxide solution.

Gallium Ga-67, with a half-life of 78.26 hours, is cyclotron produced by the proton irradiation of enriched zinc. At the time of calibration the drug contains no more than 0.02% gallium Ga-66 and no more than 0.2% zinc Zn-65. The concentration of each radionuclidic impurity changes with time.

At expiration, the drug contains no more than 0.001% gallium Ga-66 and no more than 1.0% zinc Zn-65. No carrier has been added. Gallium citrate has the following chemical structure: P hysical Characteristics Gallium Ga-67 with a physical half-life of 78.26 hours 1 decays by electron capture to stable zinc Zn-67.

Photons that are useful for imaging studies are listed in Table 1. Table 1. Principal Radiation Emission Data Radiation Mean Percent Per Disintegration Energy (keV) Gamma-2 Gamma-3 Gamma-4 Gamma-5 Gamma-6 Gamma-7 2.9 35.7 19.7 2.2 16.0 4.5 91.3 93.3 184.6 209.0 300.2 393.5 1 Kocher, D.C., Radioactive Decay Data Tables, Health and Safety Research Division, National Technical Information Service, DOE/TIC-11026, pg.

80, 1981. E xternal Radiation The specific gamma ray constant for gallium Ga-67 is

1.6R/mCi-hour at 1 cm. The first half-value thickness of lead (Pb) is 0.066 cm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of lead is shown in Table 2.

For example, the use of 1.2 cm of lead will decrease the radiation exposure by a factor of about 100. Table 2. Radiation Attenuation by Lead Shielding Shield Thickness (Pb), cm Coefficient of Attenuation 0.066 0.41 1.2 2.5 4.8 0.5 10 - 1 10 - 2 10 - 3 10 - 4 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.

Table 3. Physical Decay Chart; Gallium Ga-67, Half-Life

78.26Hours Hours Fraction Remaining Hours Fraction Remaining 0* 6 12 18 24 (1d) 30 36 42 48 (2d) 54 60 66 1.000 0.948 0.899 0.853 0.809 0.767 0.727 0.689 0.654 0.620 0.588 0.557 72 (3d) 78 84 90 96 (4d) 108 120 (5d) 132 144 (6d) 156 168 (7d) 0.529 0.501 0.475 0.451 0.427 0.384 0.345 0.311 0.279 0.251 0.226 * Calibration Time Gallium citrate chemical structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 69945-0177-01 · Curium 69945-0190-15 · Curium →
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.