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Sodium Iodide I 131 Diagnostic 100 mCi Capsule, 5-count — NDC 65174-0461-05 package photo

Sodium Iodide I 131 Diagnostic 100 mCi Capsule, 5-count

by Jubilant DraxImage Inc., dba Jubilant Radiopharma · 5 CAPSULE in 1 VIAL (65174-461-05)
NDC 65174-0461-05
🏷️ FDA NDC (as labeled) 65174-461-05 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 65174-461-05
Product NDC 65174-461
11-digit billing NDC 65174046105
NCPDP billing unit EA — each (per item)
UNII 29VCO8ACHH
Application # NDA021305
SPL Set ID 46b8d7ba-432d-d610-84f2-550bf9d0bae3
Established class (EPC) Radioactive Therapeutic 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 2006-05-01
Route ORAL
Dosage form CAPSULE
Substance SODIUM IODIDE I-131
GCN Seq No 080026
GCN 46687
HICL code 020665
Ingredient (HICL) Sodium Iodide-131
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z5
Therapeutic class — intermediate (HIC2) Radiopharmaceuticals/Radiopharmaceutical Adjuvants
HIC3 code Z5E
Therapeutic class — specific (HIC3) Radioactive Metabolic Function Diagnostics
AHFS code 36:60.00.00
AHFS class Thyroid Function
FDB label name SODIUM IODIDE I-131 3.7 MBQ CP
FDB brand name Sodium Iodide I-131
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 65174-461-05 — 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 → 65174-0461-05. 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

LabelerJubilant DraxImage Inc., dba Jubilant Radiopharma
Application holderJUBILANT DRAXIMAGE INC DBA JUBILANT RADIOPHARMA
FDA applicationNDA021305 (NDA)
Labeler code65174
First marketedMay 2006
Product typeHuman Prescription Drug
Portfolio9 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 SODIUM IODIDE I-131 3.7 MBQ CP Ingredient Sodium Iodide-131
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.

💊 What it looks like

Color White
ShapeCapsule
Size18 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 22ADO53M6F
    A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
  • UNII HX1032V43M
    Sodium thiosulfate is a salt compound used in medicines as a buffer and pH regulator. It helps stabilize the medication and may also serve as a preservative or antioxidant to maintain product quality.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

💲 Pricing

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

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

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sodium Iodide I 131 Diagnostic 100 mCithis 65174-0461-05 Jubilant 5 capsules AA 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.

Availability & generic status

🏛️
2006
On the market since
May 2006
📍
2026
Currently FDA-listed
20 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
65174-0461-05 You're viewing this 5 CAPSULE in 1 VIAL (65174-461-05) 2006-05-01 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ 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 65174-461-05, 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: 65174-0461-05, written without dashes as 65174046105. 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 65174-0461-05, the first segment (65174) is the labeler code FDA assigned to Jubilant DraxImage Inc., dba Jubilant Radiopharma; the middle segment (0461) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 Jubilant DraxImage Inc., dba Jubilant Radiopharma. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Jubilant DraxImage Inc., dba Jubilant Radiopharma 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 53 words

1 INDICATIONS AND USAGE Sodium Iodide I 131 Capsules Diagnostic is indicated for use in adults for: Assessment of thyroid function using radioactive iodine (RAI) uptake test Imaging the thyroid (scintigraphy) Sodium Iodide I 131 Capsules Diagnostic is a radioactive diagnostic agent indicated for the assessment of thyroid function and for thyroid imaging.

⏱️ Dosage and Administration ~3 min read

2 DOSAGE AND ADMINISTRATION Use careful handling with appropriate safety measures to minimize radiation exposure to patients and healthcare workers. ( 2.1 , 5.2 ) Follow suitable radioactivity calibration prior to administration. ( 2.1 ) In an adult patient, recommended doses are ( 2.2 ): Thyroid Function: 0.185 to 1.1 megabecquerels (MBq) [5 to 30 microcuries (microCi)] Thyroid Imaging: 1.85 to

3.70 MBq (50 to 100 microCi)

2.1Radiation Safety Sodium Iodide I 131 Capsules Diagnostic is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure to the patient and healthcare worker [see Warnings and Precautions ( 5.2 ) ]. Use waterproof gloves during the entire handling and administration procedure. Maintain adequate shielding during the life of the product.

Open the capsule-containing vial in a well ventilated hood to avoid exposure to trace levels of volatile I-131 which may be present. Measure patient dose by a suitable radioactivity calibration system immediately prior to administration.

2.2Recommended Dosage and Administration Instructions Administer Sodium Iodide I 131 Capsules Diagnostic orally prior to scanning. The recommended dose of Sodium Iodide I 131 Capsules Diagnostic for an adult patient is the following: Thyroid Function: 0.185 to 1.1 megabecquerels (MBq) [5 to 30 microcuries (microCi)]. Administer 24 hours before uptake measurement. Thyroid Imaging (Scintigraphy): 1.85 to

3.70MBq (50 to 100 microCi). Administer 16 -24 hours before imaging. Consult the color-coded decay calendar that is updated in January of every year to determine which colored capsule(s) correspond to the prescribed dose: https://www.draximage.com/products/us/draximage-i-131-diagnostic-capsules/ or calculate the correct dose from the date and time of calibration provided on the container label.

Prior to Sodium Iodide I 131 Capsules Diagnostic Administration Obtain a pregnacy test in females of reproductive potential prior to administration to verify the absence of pregnancy [see Contraindications ( 4 ) and Use in Specific Populations ( 8.1, 8.3 ) ]. Advise patients to maintain a low-iodine diet two weeks prior to radioiodine administration and continue for several days during the uptake or imaging process [see Drug Interactions ( 7 ) ]. Advise patients to fast at least 2 hours before and 2 hours after administration to ensure absorption.

Advise patients to hydrate before and after administration of radioiodine and void frequently to ensure rapid excretion.

2.3Radiation Dosimetry The biokinetic and radiation dose distributions associated with thyroid uptake of iodide I 131 depend on dietary intake of stable iodine. A range of uptake percentages in an average adult (73.7 kg) are shown in Table 1. For a thyroid blocked from iodide uptake in the production of hormones, the effective half-life of iodide I 131 is approximately 1.4 hours; for "low" to "high" uptake, the effective half-life of I 131 ranges from approximately 80 to 90 hours.

Table 1 Absorbed dose per unit activity sodium iodide I 131 administered orally (mGy/MBq) in adult (73.7-kg reference model) Organ Thyroid uptake of I 131 (% administered activity A 0 ) 24 h after oral administration Blocked thyroid (0% A 0 ) Low uptake (16% A 0 ) Medium uptake (26% A 0 ) High uptake (36% A 0 ) Adrenals 0.044 0.051 0.055 0.059 Bone surfaces 0.030 0.089 0.12

0.16Brain 0.021 0.093 0.13

0.17Breast 0.020 0.038 0.048 0.058 Gallbladder wall 0.037 0.043 0.046 0.049 Gastrointestinal tract Stomach wall 0.87 0.77 0.71

0.66Small intestine wall 0.035 0.033 0.032 0.032 Colon wall 0.14 0.14 0.14 0.14 (Upper large intestine wall) 0.12 0.12 0.12 0.12 (Lower large intestine wall) 0.17 0.17 0.17

0.16Heart wall 0.062 0.089 0.10

0.12Kidneys 0.27 0.27 0.27

0.27Liver 0.050 0.093 0.12

0.14Lungs 0.053 0.10 0.13

0.15Muscles 0.026 0.084 0.12

0.15Oesophagus 0.024 0.10 0.14

0.19Ovaries 0.038 0.037 0.036 0.035 Pancreas 0.060 0.064 0.066 0.068 Red marrow 0.031 0.072 0.…

💊 Dosage Forms and Strengths 137 words

3 DOSAGE FORMS AND STRENGTHS Capsules: Each capsule contains

3.70MBq (100 microCi) at time of calibration. Half of each capsule is white, while the other half is either pink, yellow, orange, grey or green according to the manufactured lot. The capsule will yield 2.03, 1.11, 0.61, or

0.33MBq (55, 30, 16.5, or 9 microCi) according to the color-coded decay calendar which assigns a color and capsule activity for each week of the year. https://www.draximage.com/products/us/draximage-i-131-diagnostic-capsules/ Table 2 below displays the (5) weeks activity of the capsule starting from the calibration day. Table 2 Weekly Activity (MBq and microCi) of Each Capsule Starting from the Calibration Day Week Activity (MBq) Activity (microCi) 1 3.70 100.0 2 2.03 54.9 3 1.11 30.0 4 0.61 16.5 5 0.33

8.9 Capsules:

3.70 MBq (100 microCi) at the time of calibration

Contraindications 29 words

4 CONTRAINDICATIONS Sodium Iodide I 131 Capsules Diagnostic is contraindicated in pregnancy [see Warnings and Precautions ( 5.1 ) , Use in Specific Populations ( 8.1 ) ]. Pregnancy

⚠️ Warnings and Cautions ~1 min read

5 WARNINGS AND PRECAUTIONS Fetal Toxicity – I 131 can cause severe and irreversible hypothyroidism in the neonate. Verify absence of pregnancy before administering the product. ( 4 , 5.1 , 8.1, 8.3 ) Radiation Risk – I 131 contributes to patients’s long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Ensure safe handling to minimize radiation exposure. ( 5.2 )

5.1Fetal Toxicity Sodium Iodide I 131 Capsules Diagnostic is contraindicated in pregnancy because sodium iodide I 131 crosses the placenta and can cause severe and irreversible hypothyroidism in the neonate. Multiple reports in the literature describe neonatal hypothryroidism following in utero exposure to sodium iodide I 131. Some of these cases were severe and irreversible.

Verify pregnancy status of females of reproductive potential prior to administering Sodium Iodide I 131 Capsules Diagnostic [see Use in Specific Populations ( 8.1, 8.3 ) ].

5.2Radiation Exposure Sodium Iodide I 131 Capsules Diagnostic contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Follow safe administration instructions to minimize radiation exposure to the patient and healthcare providers [see Dosage and Administration ( 2.1 ) ].

5.3Risk of Radioactive Uptake Measurement and Imaging Misinterpretation The recent intake of stable iodine in any form, or the use of thyroid or anti-thyroid drugs will affect the uptake of sodium iodide I 131. Question the patient carefully regarding their exposure to these drugs or procedures involving radiographic contrast media [see Drug Interactions ( 7 ) ].

5.4Hypersensitivity Reactions Hypersensitivity reactions including anaphylaxis may occur in patients who receive sodium iodide I 131. Although iodine is not considered an allergen, hypersensitivity reactions may occur in relation with excipients or chemical component of the capsule, such as sodium thiosulfate. Obtain and document an allergy history, particularly a sulfite allergy.

Emergency resuscitation equipment and personnel should be immediately available [see Adverse Reactions ( 6 ) ].

🤒 Adverse Reactions 154 words

6 ADVERSE REACTIONS The following adverse reaction has been described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 ) ] The following adverse reactions have been identified during post-approval use from Sodium Iodide I 131 Capsules Diagnostic. Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions associated with the administration of Sodium Iodide I 131 Capsules Diagnostic are: Gastrointestinal disorders: vomiting, nausea, and diarrhea General disorders and administration site conditions: local thyroid swelling Immune system disorders: hypersensitivity reactions Skin and subcutaneous tissue disorders: itching, rash, hives, and erythema Common adverse reactions reported with diagnostic doses of sodium iodide I 131 include nausea, vomiting, itching, rash and hives.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Jubilant DraxImage Inc. at 1-888-633-5343 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 192 words

7 DRUG INTERACTIONS Certain drugs and iodine-containing foods interfere with the accumulation of radioiodide by the thyroid. Review the patients history, current medications, and recent diagnostic tests prior to the administration of Sodium Iodide I-131 Capsules Diagnostic. Advise patients to maintain a low-iodine diet two weeks prior to radioiodine administration and continue for several days during the uptake or imaging process and to discontinue the following products before they undergo the procedure as shown in Table 3: Table 3 Pharmaceuticals/OTCs/Agents Blocking Radioiodine Uptake ​Products Recommended duration of withdrawal Thionamide medications (e.g., propylthiouracil, methimazole carbimazole) 3 days Multivitamins containing iodide 10 days Natural or synthetic thyroid hormones triiodothyronine thyroxine 2 weeks 4 weeks Iodine containing foods: iodinized salt, dairy products, egg yolks, seafood, turkey, and liver 2 weeks Kelp, agar, carrageenan, Lugol solution 3 weeks Saturated solution of potassium iodide 3 weeks Topical iodine (e.g., surgical skin preparation) 3 weeks Radiographic contrast agents Water soluble Lipophilic 2 months 6 months Amiodarone 6 months The recent intake of iodine in any form or the use of thyroid or anti-thyroid drugs will affect the uptake of sodium iodide I 131.

( 5.3 , 7 )

👥 Use in Specific Populations ~2 min read

8 USE IN SPECIFIC POPULATIONS Lactation: Discontinue breastfeeding. ( 8.2 ) Renal Impairment: Increases radiation exposure. ( 8.6 )

8.1Pregnancy Risk Summary Sodium Iodide I 131 Capsules Diagnostic is contraindicated in pregnancy because fetal exposure can lead to neonatal hypothyroidism, which in some cases is severe and irreversible. Data from the published literature describe reports of neonatal thyroid abnormalities after fetal exposure, including agenesis of the thyroid and hypothyroidism (see Clinical Considerations, Data ). No animal reproductive studies have been conducted.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions A fetus exposed to sodium iodide I 131 can develop neonatal hypothyroidism.

Delay in diagnosis of neonatal hypothyroidism after exposure to sodium iodide I 131 in utero can result in severe sequelae such as decreased mental capacity and delayed skeletal maturation. Monitor thyroid function in any infant born after in utero exposure to sodium iodide I 131. Data Human Data Literature reports of maternal exposures to sodium iodide I 131 at doses of 330-8300 MBq during 4-26 weeks estimated gestational age.

There were various adverse pregnancy outcomes; the most common was hypothyroidism in infants and children.

8.2Lactation Risk Summary Advise women to discontinue breastfeeding after administration of Sodium Iodide I 131 Capsules Diagnostic. Infant exposure to sodium iodide I 131 via breast milk is expected and may lead to hypothyroidism in the infant because sodium iodide I 131 in breast milk may reach concentrations equal to or greater than concentrations in maternal plasma (see Data ). Data Published studies show that sodium iodide I 131 is transferred into breast milk and is taken up by the thyroid of the breastfed infant.

8.3Females and Males of Reproductive Potential Sodium Iodide I 131 is contraindicated in pregnancy because it causes fetal hypothyroidism [see Use in Specific Populations ( 8.1 ) and Warnings and Precautions ( 5.1 ) ]. Pregnancy Testing Obtain a pregnancy test in females of reproductive potential and verify the absence of pregnancy before administering Sodium Iodide I 131 Capsules Diagnostic [see Dosage and Administration ( 2.2 ) ].

8.4Pediatric use Safety and efficacy in pediatric patients have not been established. Published reports suggest that the thyroid gland of pediatric patients is more sensitive to the adverse effects of sodium iodide I 131 (e.g., increased risk of radiation absorption).

8.5Geriatric Use Clinical experience has not identified differences in safety or effectiveness in geriatric patients compared to younger patients. However, elderly patients are more likely to have decreased renal function and radiation exposure is greater in patients with impaired renal function [see Use in Specific Populations ( 8.6 ) , Clinical Pharmacology ( 12.3 ) ].

8.6Renal Impairment Radiation exposure following Sodium Iodide I 131 Capsules Diagnostic is greater in patients with impaired renal function compared to patients with normal renal function [see Clinical Pharmacology ( 12.3 ) ].

🤰 Pregnancy 204 words

8.1Pregnancy Risk Summary Sodium Iodide I 131 Capsules Diagnostic is contraindicated in pregnancy because fetal exposure can lead to neonatal hypothyroidism, which in some cases is severe and irreversible. Data from the published literature describe reports of neonatal thyroid abnormalities after fetal exposure, including agenesis of the thyroid and hypothyroidism (see Clinical Considerations, Data ). No animal reproductive studies have been conducted.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions A fetus exposed to sodium iodide I 131 can develop neonatal hypothyroidism.

Delay in diagnosis of neonatal hypothyroidism after exposure to sodium iodide I 131 in utero can result in severe sequelae such as decreased mental capacity and delayed skeletal maturation. Monitor thyroid function in any infant born after in utero exposure to sodium iodide I 131. Data Human Data Literature reports of maternal exposures to sodium iodide I 131 at doses of 330-8300 MBq during 4-26 weeks estimated gestational age.

There were various adverse pregnancy outcomes; the most common was hypothyroidism in infants and children.

🧒 Pediatric Use 41 words

8.4Pediatric use Safety and efficacy in pediatric patients have not been established. Published reports suggest that the thyroid gland of pediatric patients is more sensitive to the adverse effects of sodium iodide I 131 (e.g., increased risk of radiation absorption).

🧓 Geriatric Use 57 words

8.5Geriatric Use Clinical experience has not identified differences in safety or effectiveness in geriatric patients compared to younger patients. However, elderly patients are more likely to have decreased renal function and radiation exposure is greater in patients with impaired renal function [see Use in Specific Populations ( 8.6 ) , Clinical Pharmacology ( 12.3 ) ].

🆘 Overdosage 45 words

10 OVERDOSAGE In the event of an overdosage of Sodium Iodide I 131 Capsules Diagnostic, monitor for thyroid suppression and consider administering a thyroid blocking agent (e.g. potassium iodide (KI) or perchlorate). Promote frequent voiding and encourage patients to maintain hydration to minimize radiation exposure.

🧬 Clinical Pharmacology ~1 min read

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Iodine is actively transported by the sodium-iodide symporter (NIS) protein, in thyroid follicular cells. Iodide is concentrated in follicular cells up to 50 times higher than in the plasma. Iodide is metabolically oxidized by thyroid peroxidase to iodinium (I + ) which in turn iodinates tyrosine residues of thyroglobulin (tri or tetra-iodinated tyrosine). The gamma emission of Iodine I 131 is imaged or counted.

12.3Pharmacokinetics Absorption Following oral administration of Sodium Iodide I 131 Capsules Diagnostic, 90% of the administered radioactivity of sodium iodide I 131 is systemically absorbed in the first 60 minutes. Distribution Following absorption, sodium iodide I 131 is distributed within the extra-cellular space. It is actively transported by the sodium-iodide symporter (NIS) protein and binds to thyroglobulin resulting in accumulation in the thyroid.

The thyroid uptake of iodide is usually increased in hyperthyroidism and in goiter, and is decreased in hypothyroidism. Sodium iodide I 131 also accumulates in the stomach, choroid plexus, salivary glands breast, liver, gall bladder, and kidneys. Elimination Metabolism In thyroid follicular cells, iodide is oxidized through the action of thyroid peroxidase to iodinium (I + ) which in turn iodinates tyrosine residues of thyroglobulin.

Excretion Sodium iodide I 131 is excreted in urine and feces. The normal range of urinary excretion is 37% to 75% of the administered dose, varying with the thyroid and renal function of the patient. Fecal excretion is about 10%.

🧬 Mechanism of Action 68 words

12.1Mechanism of Action Iodine is actively transported by the sodium-iodide symporter (NIS) protein, in thyroid follicular cells. Iodide is concentrated in follicular cells up to 50 times higher than in the plasma. Iodide is metabolically oxidized by thyroid peroxidase to iodinium (I + ) which in turn iodinates tyrosine residues of thyroglobulin (tri or tetra-iodinated tyrosine). The gamma emission of Iodine I 131 is imaged or counted.

📦 How Supplied / Storage and Handling 191 words

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Each capsule contains 3.70 megabecquerels (100 microCi) at time of calibration. Half of each capsule is white, while the other half is either pink, yellow, orange, grey or green according to the manufactured lot. The capsules are packaged in plastic vials containing 5 capsules of the same strength and same color.

(NDC 65174-461-05). Consult the color-coded decay calendar that is updated in January of each year to help you establish which colored capsules correspond to your prescribed dose: https://www.draximage.com/products/us/draximage-i-131-diagnostic-capsules/ or calculate the correct dosage from the date and time of calibration provided on the container label. The calibration date and expiration date are indicated on the vial container label.

16.2Storage and Handling Store Sodium Iodide I 131 Capsules Diagnostic between 15 °C and 30 °C (59 °F and 86 °F). Store and dispose of Sodium Iodide I 131 Capsules Diagnostic in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide. This radiopharmaceutical is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

📋 Description ~2 min read

11 DESCRIPTION

11.1Chemical Characteristics Sodium Iodide I 131 Capsules Diagnostic is a radiodioactive diagnostic agent containing sodium iodide I 131 and supplied for oral administration in a gelatin capsule. Each capsule contains no-carrier-added sodium iodide I 131, disodium edetate dihydrate USP as a stabilizer, sodium thiosulfate pentahydrate USP as a reducing agent, and dibasic sodium phosphate anhydrous USP. Sodium Iodide I 131 is designated chemically as Na131I and has a molecular weight of 153.99.

11.2Physical Characteristics Iodine I 131 decays by beta emission and associated gamma emission with a physical half-life of 8.04 days. The principal radiation emissions are listed in Table 4. Table 4 Principal Radiation Emission Data from Decay of Sodium Iodide I 131 Radiation Mean % per Disintegration Mean Energy (keV) Beta-1 2.13%

69.4Beta-3 7.20%

96.6Beta-4 89.4% 191.6 Gamma-7 6.14% 284.3 Gamma-14 81.2% 364.5 Gamma-18 7.12% 637.0

11.3External Radiation The specific gamma-ray constant for iodine I 131 is 4.26 x 10 -13 C•m 2 •kg -1 •MBq -1 •s -1 (2.2 R•cm 2 /mCi•hr). The first half-value thickness of lead (Pb) for iodine I 131 is 0.27 cm. A range of values for the relative attenuation of the radiation emitted by iodine I 131 that results from interposition of various thicknesses of Pb is shown in Table 5.

For example, the use of 2.59 cm of Pb will decrease the external radiation exposure by a factor of about 100. Table 5 Radiation Attenuation of Iodine I 131 by Lead Shielding Shield Thickness (Pb) cm Coefficient of Attenuation 0.27 0.5 0.56 0.25 0.99 10 -1 2.59 10 -2 4.53 10 -3 To correct for physical decay of iodine I 131, the fractions that remain at selected intervals after the time of calibration are shown in Table 6. Table 6 Physical Decay Chart: Iodine I 131, Half-Life 8.04 days Days Fraction Remaining Days Fraction Remaining Days Fraction Remaining 0 Calibration Time 1.000 11 0.388 22 0.151 1 0.918 12 0.356 23 0.138 2 0.842 13 0.327 24 0.127 3 0.773 14 0.300 25 0.116 4 0.709 15 0.275 26 0.107 5 0.651 16 0.253 27 0.098 6 0.597 17 0.232 28 0.090 7 0.548 18 0.213 29 0.083 8 0.503 19 0.195 30 0.076 9 0.461 20 0.179 10 0.423 21 0.164

💬 Information for Patients 161 words

17 PATIENT COUNSELING INFORMATION Administration Instructions Advise patients to hydrate before and after administration of Sodium Iodide I 131 Capsules Diagnostic and void frequently to ensure rapid excretion [see Dosage and Administration ( 2.2 ) ]. Advise patients to fast at least 2 hours before and 2 hours after administration to ensure absorption [see Dosage and Administration ( 2.2 ) ]. Advise patients to maintain a low-iodine diet two weeks prior to radioiodine administration and continue for several days during the uptake or imaging process [See Dosage and Administration ( 2.2 ) and Drug Interactions ( 7 ) ].

Fetal Toxicity Advise female patients of reproductive potential of the risk of neonatal hypothyroidism with fetal exposure [see Contraindications ( 4 ) , Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1, 8.3 ) ]. Lactation Advise women to discontinue breastfeeding after Sodium Iodide I 131 Capsules Diagnostic administration [see Use in Specific Populations ( 8.2 ) ].

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