I 123 Mini

Manufacturer
AnazaoHealth Corporation
Effective date
2012-05-23
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:16:20

Label at a glance#

ProductI 123 Mini
Active ingredientIODIDE ION I-123
Label structure6 sections

Indications and uses

Administration of Sodium Iodide I-123 is indicated as a diagnostic procedure to be used in evaluating thyroid function and/or morphology

Dosage and administration

Anti-thyroid therapy of a severely hyperthyroid patient is usually discontinued three to four days before administration of radioiodide.  For hyperthyroidism, the usual dose range is 4 to 10 mCi.  Toxic nodular goiter and other special situations will require the use of larger doses.  For thyroid carcinoma, 50 mCi is the usual dose for ablation of normal thyroid tissue, and 100 to 150 mCi is the usual subsequent t...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Dear Medical Professional, Per your order, we have compounded I-123 in Mini Cap form. The characteristics of this compound are:

DESCRIPTION

DESCRIPTION SECTION

Sodium Iodide I-123 (NaI-123) for diagnostic use is supplied for oral administration in a small opaque white gelatin capsule, which is placed inside a red and clear outer capsule. The capsules are available in strengths up to 10 mCi of I-123 at a specific time. Gelatin capsules are compounded, per prescription requirements, using high specific concentration I-123, allowing higher iodine activity in a small easy to swallow capsule size.The radionuclidic composition at calibration is not less than 97.0 percent I-123, not more than 2.9 percent I-125 and not more than 0.1 percent Te-121. The radionuclidic composition at expiration time is not less than 87.2 percent I-123, not more than 12.4 percent I-125 and not more than 0.4 percent Te-121. The ratio of the concentration of I-123 and I-125 changes with time. Iodine-123 has a physical half-life of 13.2 hours.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Administration of Sodium Iodide I-123 is indicated as a diagnostic procedure to be used in evaluating thyroid function and/or morphology

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Anti-thyroid therapy of a severely hyperthyroid patient is usually discontinued three to four days before administration of radioiodide.  For hyperthyroidism, the usual dose range is 4 to 10 mCi.  Toxic nodular goiter and other special situations will require the use of larger doses.  For thyroid carcinoma, 50 mCi is the usual dose for ablation of normal thyroid tissue, and 100 to 150 mCi is the usual subsequent therapeutic dose. Waterproof gloves should be used during the entire handling and administration procedure. Adequate shielding must be maintained.

CLINICAL UTILITY

CLINICAL STUDIES SECTION

.Sodium Iodide I-123 is readily absorbed from the upper gastrointestinal tract. Following absorption, the iodide is distributed primarily within the extracellular fluid of the body. It is trapped and organically bound by the thyroid and concentrated by the stomach, choroid plexus and salivary glands. It is excreted by the kidneys. The fraction of the administered dose which is accumulated in the thyroid gland may be a measure of thyroid function in the absence of unusually high or low iodine intake or administration of certain drugs which influence iodine accumulation by the thyroid gland. Normal subjects can accumulate approximately 10 to 50% of the administered iodine dose in the thyroid gland, however, the normal and abnormal ranges are established by individual physician’s criteria. The mapping (imaging) of Sodium Iodide I-123 distribution in the thyroid gland may provide useful information concerning thyroid anatomy and definition of normal and/or abnormal functioning of tissue within the gland

Thank you,

AnazaoHealth Corporation

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
IODIDE ION I-123 Pharmacologic Class Indexing2Indexing - Pharmacologic Class20110330

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51808-102-012019-11-27C16284748780-19855d018-e585-cd31-e053-dbdaa90ab51aI-123 Mini Caps Medical Professional Information Sheet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51808-102-01I 123 Mini2 in 1 VIALCAPSULE21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51808-102I 123 MINI CAPSULE [ANAZAOHEALTH CORPORATION]1Legacy NDC, 1 package rows20121203_ba4a725e-ba46-427c-b309-a5ddc3c881ab.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
IODIDE ION I-123ACTIVE INGREDIENT8YWR746RPQ1
IODIDE ION I-123ACTIVE MOIETY8YWR746RPQ1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA741

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51808-10251808-102-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
IODIDE ION I-1238YWR746RPQACTIB
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74CONCENTRATE / ORAL17 mg/5mlExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS40 mgExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74SUSPENSION / OPHTHALMIC0.43 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74CREAM / TOPICAL0.1 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION / INTRAMUSCULAR40 mgExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74SYRUP / ORAL70 mgExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74TABLET, EXTENDED RELEASE / ORAL143 mgExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION / INTRADERMAL0.2 %w/vExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION / SUBCUTANEOUS14 mgExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR40 mgExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74FILM, SOLUBLE / ORAL9 mgExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION / INTRAVENOUS200 mgExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74SOLUTION / ORAL40 mg/1mlExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS2.98 mgExact identifier — unii candidate
14 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
130c71b9-1a33-45b2-ab19-e38b6ee0ee68ba4a725e-ba46-427c-b309-a5ddc3c881ab2012-05-23Exact identifier
spl id: 130c71b9-1a33-45b2-ab19-e38b6ee0ee68
spl set id: ba4a725e-ba46-427c-b309-a5ddc3c881ab

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.