Indications and uses
Administration of Sodium Iodide I 123 Capsules is indicated as a diagnostic procedure to be used in evaluating thyroid function and/or morphology.
Sodium Iodide I 123 Capsules Rx only Diagnostic - For Oral Administration
- Manufacturer
- Curium US LLC
- Effective date
- 2024-10-17
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 10
- Source
- full-release
- Hydrated at
- 2026-05-31 21:14:55
Label at a glance#
ProductSODIUM IODIDE I 123
Active ingredientSODIUM IODIDE I-123
Label structure11 sections
Dosage and administration
The recommended oral dose for the average patient (70 kg) is 3.7 to 14.8 MBq (100 to 400 μCi). The lower part of the dosage range 3.7 MBq (100 μCi) is recommended for uptake studies alone, and the higher part 14.8 MBq (400 μCi) for thyroid imaging. The determination of I-123 concentration in the thyroid gland may be initiated at six hours after administering the dose and should be measured in accordance with stand...
Label contents#
Full prescribing information#
DESCRIPTION
Sodium Iodide I 123 (Na 123I) for diagnostic use is supplied in capsules for oral administration. The capsules are available in strengths of 3.7 and 7.4 megabecquerels (MBq) (100 and 200 μCi) I-123 at time of calibration.
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. Graph 1 shows the minimum concentration of I-123 as a function of time and Graph 2 shows the maximum concentration of I-125 as a function of time.
Graph 1. Radionuclidic Concentration of I-123
PERCENT OF TOTAL RADIOACTIVITY:
IODINE-123
Graph 2. Radionuclidic Concentration of I-125
PERCENT OF TOTAL RADIOACTIVITY:
IODINE-125
Physical Characteristics
Iodine-123 decays by electron capture with a physical half-life of 13.2 hours 1. The photon that is useful for detection and imaging studies is listed in Table 1.
| Radiation | Mean %
Disintegration | Energy
(keV) |
| Gamma-2 | 83.4 | 159 |
1 Kocher, David C., Radioactive Decay Data Tables. DOE/TIC-11026, 122 (1981).
External Radiation
The specific gamma ray constant for I-123 is 1.6 R/hr-mCi at 1 cm. The first half-value thickness of lead (Pb) for I-123 is 0.005 cm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from the interposition of various thicknesses of Pb is shown in Table 2. For example, the use of 1.63 cm of lead will decrease the external radiation exposure by a factor of about 1,000.
| Shield
Thickness (Pb), cm | Coefficient of
Attenuation |
| 0.005
0.10 0.88 1.63 2.48 | 0.5
10 -1 10 -2 10 -3 10 -4 |
Note that these estimates of attenuation do not take into consideration the presence of radionuclidic contaminants.
To correct for physical decay of I-123, the fractions that remain at selected intervals after the time of calibration are shown in Table 3.
Hours | Fraction
Remaining | Hours | Fraction Remaining | |
*Time of Calibration | ||||
| 0*
3 6 9 12 15 | 1.000
0.854 0.730 0.623 0.533 0.455 | 18
21 24 27 30 | 0.389
0.332 0.284 0.242 0.207 | |
CLINICAL PHARMACOLOGY
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. Accordingly, the patient should be questioned carefully regarding previous medications and/or procedures involving radiographic media. 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.
INDICATIONS AND USAGE
Administration of Sodium Iodide I 123 Capsules is indicated as a diagnostic procedure to be used in evaluating thyroid function and/or morphology.
CONTRAINDICATIONS
To date there are no known contraindications to the use of Sodium Iodide I 123 Capsules.
WARNINGS
Females of childbearing age and pediatric patients should not be studied unless the benefits anticipated from the performance of the test outweigh the possible risk of exposure to the amount of ionizing radiation associated with the test.
PRECAUTIONS
General
The contents of the capsule are radioactive. Adequate shielding of the preparation must be maintained at all times.
Do not use after the expiration time and date stated on the label.
The prescribed Sodium Iodide I 123 dose should be administered as soon as practical from the time of receipt of product (i.e., as close to calibration time as possible), in order to minimize the fraction of radiation exposure due to the relative increase of radionuclidic contaminants with time.
Sodium iodide I-123, as well as other radioactive drugs, must be handled with care and appropriate safety measures should be used to minimize radiation exposure to clinical personnel. Care should also be taken to minimize radiation exposure to the patient consistent with proper patient management.
Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential, or whether sodium iodide I-123 affects fertility in males or females.
Pregnancy Category C
Animal reproduction studies have not been conducted with this drug. It is also not known whether sodium iodide I-123 can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Sodium iodide I-123 should be given to a pregnant woman only if clearly needed.
Ideally, examinations using radiopharmaceuticals, especially those elective in nature, in women of child-bearing capability should be performed during the first few (approximately ten) days following the onset of menses.
Nursing Mothers
Since I-123 is excreted in human milk, formula-feeding should be substituted for breast-feeding if the agent must be administered to the mother during lactation.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
ADVERSE REACTIONS
Although rare, reactions associated with the administration of sodium iodide isotopes for diagnostic use include, in decreasing order of frequency, nausea, vomiting, chest pain, tachycardia, itching skin, rash and hives.
DOSAGE AND ADMINISTRATION
The recommended oral dose for the average patient (70 kg) is 3.7 to 14.8 MBq (100 to 400 μCi). The lower part of the dosage range 3.7 MBq (100 μCi) is recommended for uptake studies alone, and the higher part 14.8 MBq (400 μCi) for thyroid imaging. The determination of I-123 concentration in the thyroid gland may be initiated at six hours after administering the dose and should be measured in accordance with standardized procedures.
The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. The capsules can be utilized up to 30 hours after calibration time and date. Thereafter, discard the capsules in accordance with standard safety procedures. The user should wear waterproof gloves at all times when handling the capsules or container.
Radiation Dosimetry
The estimated absorbed radiation doses to several organs of an average patient (70 kg) from oral administration of the maximum dose of 14.8 MBq (400 μCi) of I-123 are shown in Table 4 for thyroid uptakes of 5, 15, and 25%. For comparison at these three values of thyroid uptake, the estimated radiation doses from doses of 3.7 MBq (100 μCi) I-131, also used as thyroid imaging agent, are also included.
| Estimated Radiation Absorbed Doses | ||||
| I-123
mGy/14.8 MBq (rads/400 μCi) | I-131
mGy/3.7 MBq (rads/100 μCi) | |||
| Target Organ | Maximum Thyroid
Uptake (%) | TOC | TOE | |
*Concentration at Time of Calibration: 97% I-123, 2.9% I-125, 0.1% Te-121 | ||||
Concentration at Time of Expiry: 87.2% I-123, 12.4% I-125, 0.4% Te-121 | ||||
Metabolic model in MIRD Dose Estimate Report 5 followed for I-123 and I-125 | ||||
Metabolic model in ICRP 30 followed for Te-121 | ||||
†Bladder voiding interval 4.8 hours. | ||||
| Bladder † | 5 | 1.7 (0.17) | 1.7 (0.17) | 2.9 (0.29) |
| 15 | 1.6 (0.16) | 1.6 (0.16) | 2.7 (0.27) | |
| 25 | 1.4 (0.14) | 1.5 (0.15) | 2.4 (0.24) | |
| Stomach Wall | 5 | 0.96 (0.096) | 0.98 (0.098) | 1.7 (0.17) |
| 15 | 0.89 (0.089) | 0.91 (0.091) | 1.5 (0.15) | |
| 25 | 0.82 (0.082) | 0.85 (0.085) | 1.4 (0.14) | |
| Small Intestine | 5 | 0.70 (0.070) | 0.71 (0.071) | 1.2 (0.12) |
| 15 | 0.65 (0.065) | 0.67 (0.067) | 1.1 (0.11) | |
| 25 | 0.60 (0.060) | 0.62 (0.062) | 0.99 (0.099) | |
| Liver | 5 | 0.089 (0.0089) | 0.13 (0.013) | 0.16 (0.016) |
| 15 | 0.10 (0.010) | 0.18 (0.018) | 0.28 (0.028) | |
| 25 | 0.11 (0.011) | 0.24 (0.024) | 0.41 (0.041) | |
| Ovaries | 5 | 0.18 (0.018) | 0.19 (0.019) | 0.18 (0.018) |
| 15 | 0.17 (0.017) | 0.18 (0.018) | 0.18 (0.018) | |
| 25 | 0.16 (0.016) | 0.18 (0.018) | 0.17 (0.017) | |
| Skeleton | 5 | 0.11 (0.011) | 0.16 (0.016) | 0.12 (0.012) |
| 15 | 0.12 (0.012) | 0.18 (0.018) | 0.18 (0.018) | |
| 25 | 0.14 (0.014) | 0.21 (0.021) | 0.24 (0.024) | |
| Red Marrow | 5 | 0.12 (0.012) | 0.16 (0.016) | 0.15 (0.015) |
| 15 | 0.12 (0.012) | 0.18 (0.018) | 0.21 (0.021) | |
| 25 | 0.13 (0.013) | 0.19 (0.019) | 0.27 (0.027) | |
| Testes | 5 | 0.076 (0.0076) | 0.089 (0.0089) | 0.12 (0.012) |
| 15 | 0.072 (0.0072) | 0.087 (0.0087) | 0.12 (0.012) | |
| 25 | 0.068 (0.0068) | 0.085 (0.0085) | 0.12 (0.012) | |
| Thyroid | 5 | 25 (2.5) | 75 (7.5) | 260 (26) |
| 15 | 77 (7.7) | 230 (23) | 780 (78) | |
| 25 | 130 (13) | 410 (41) | 1300 (130) | |
| Total Body | 5 | 0.11 (0.011) | 0.16 (0.016) | 0.24 (0.024) |
| 15 | 0.14 (0.014) | 0.25 (0.025) | 0.47 (0.047) | |
| 25 | 0.17 (0.017) | 0.35 (0.035) | 0.70 (0.070) | |
HOW SUPPLIED
Catalog Number 601,602.
Sodium Iodide I 123 is supplied as capsules for oral administration in strengths of 3.7 MBq (100 µCi) (red and white) (NDC 69945-601-10) and 7.4 MBq (200 µCi) (green and white) (NDC 69945-602-20) at time of calibration. Each gelatin capsule contains sucrose as a filler. The capsules are packaged in plastic vials containing one capsule of a single strength per vial. The plastic vial is packaged in a lead shield. A package insert is supplied with each lead shield.
Storage and Handling
The contents of the vial are radioactive and adequate shielding and handling precautions must be maintained.
Dispense and preserve capsules in tightly-closed containers that are adequately shielded. Store at controlled room temperature 20° to 25°C (68° to 77°F).
Storage and disposal of Sodium Iodide I 123 Capsules 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.
Curium and the Curium logo are trademarks of a Curium company.
©2018 Curium US LLC. All Rights Reserved.
Manufactured by: Curium US LLC
Maryland Heights, MO 63043
Made in USA
A601I0
R12/2018
CURIUM™
PRINCIPAL DISPLAY PANEL - A601C0
Sodium Iodide I 123 Capsules
DIAGNOSTIC
For Oral Administration Only
Store at Controlled Room Temperature
20º to 25°C (68º to 77°F)
READ PACKAGE INSERT FOR DIRECTIONS FOR USE
Rx only
WARNING:Radioactive drugs must be handled only by qualified personnel in conformity with regulations of the U.S. Nuclear Regulatory Commission or state regulatory agencies where applicable. Bottle containing drug should be kept in this container or within a heavier shield.
Manufactured by:
Curium US LLC
Maryland Heights, MO 63043
Made in USA
CURIUM™
CAUTION RADIOACTIVE MATERIAL
A601C0
R12/2018
PRINCIPAL DISPLAY PANEL - A602C0
Sodium Iodide I 123 Capsules
DIAGNOSTIC
For Oral Administration Only
Store at Controlled Room Temperature
20º to 25°C (68º to 77°F)
READ PACKAGE INSERT FOR DIRECTIONS FOR USE
Rx only
WARNING:Radioactive drugs must be handled only by qualified personnel in conformity with regulations of the U.S. Nuclear Regulatory Commission or state regulatory agencies where applicable. Bottle containing drug should be kept in this container or within a heavier shield.
Manufactured by:
Curium US LLC
Maryland Heights, MO 63043
Made in USA
CAUTION RADIOACTIVE MATERIAL
CURIUM™
A602C0 R12/2018
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69945-601-10 | SODIUM IODIDE I 123 | 1 in 1 CAN | CAPSULE, GELATIN COATED | 1 | 10 | |
| 69945-601-10 | SODIUM IODIDE I 123 | 1 in 1 BOTTLE | CAPSULE, GELATIN COATED | 1 | 10 | |
| 69945-602-20 | SODIUM IODIDE I 123 | 1 in 1 BOTTLE | CAPSULE, GELATIN COATED | 1 | 10 | |
| 69945-602-20 | SODIUM IODIDE I 123 | 1 in 1 CAN | CAPSULE, GELATIN COATED | 1 | 10 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69945-601 | SODIUM IODIDE I 123 CAPSULE, GELATIN COATED [CURIUM US LLC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20241019_493fa2ab-4eb0-4434-9739-3079b2f0e272.zip |
| 69945-602 | SODIUM IODIDE I 123 CAPSULE, GELATIN COATED [CURIUM US LLC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20241019_493fa2ab-4eb0-4434-9739-3079b2f0e272.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| SODIUM IODIDE I-123 | ACTIVE INGREDIENT | 29UKX3A616 | 2 | |
| IODIDE ION I-123 | ACTIVE MOIETY | 98QPV8670C | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 2 |
Products#
Every source-derived product name is available through these pages.
- SODIUM IODIDE I 123
- SUCROSE
- SODIUM IODIDE I-123
- IODIDE ION I-123
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69945-601 | 69945-601-10 |
| 69945-602 | 69945-602-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCROSE | C151H8M554 | IACT |
| SODIUM IODIDE I-123 | 29UKX3A616 | ACTIM |
| SUCROSE | C151H8M554 | IACT |
| SODIUM IODIDE I-123 | 29UKX3A616 | ACTIM |
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION, EXTENDED RELEASE / ORAL | 5400 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, FILM COATED / ORAL | 145 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION/ DROPS / ORAL | 3750 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | SYRUP / ORAL | 46400 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 86 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, DELAYED RELEASE / ORAL | 955 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 119.12 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 86 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, EXTENDED RELEASE / ORAL | 619 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, COATED / ORAL | 516.42 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CONCENTRATE / ORAL | 4800 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION/ DROPS / ORAL | 3750 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SOLUTION / ORAL | 42596 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER, FOR SOLUTION / ORAL | 38666 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CONCENTRATE / ORAL | 4800 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, DELAYED RELEASE / ORAL | 955 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION/ DROPS / ORAL | 3750 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TROCHE / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SOLUTION / ORAL | 42596 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION/ DROPS / ORAL | 3750 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 86 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 119.12 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, COATED PELLETS / ORAL | 59.8 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TROCHE / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, EXTENDED RELEASE / ORAL | 619 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | PASTILLE / ORAL | 426 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, COATED PELLETS / ORAL | 59.8 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CONCENTRATE / ORAL | 4800 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TROCHE / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION, EXTENDED RELEASE / ORAL | 5400 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER, FOR SOLUTION / ORAL | 38666 mg |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A071909-001 | SODIUM IODIDE I 123 | SODIUM IODIDE I-123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A071909-001 | AA |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A071909-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | AA | 1989-02-28 | 3a93d1ddd44b… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A071909-001 | AA | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A071909-001 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A071909-001 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A071909-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071909-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A071909-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071909-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071909-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071909-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071909-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071909-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071909-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A071909-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071909-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071909-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071909-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A071909-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A071909-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A071909-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A071909-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A071909-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A071909-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A071909-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A071909-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A071909-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A071909-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A071909-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A071909-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A071909-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A071909-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A071909-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A071909-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A071909-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A071909-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A071909-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A071909-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A071909-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A071909-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A071909-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A071909-001 | AA | 1 | 3a93d1ddd44b… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A071910-001 | SODIUM IODIDE I 123 | SODIUM IODIDE I-123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A071910-001 | AA |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A071910-001 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | AA | 1989-02-28 | 3a93d1ddd44b… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A071910-001 | AA | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A071910-001 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A071910-001 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A071910-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071910-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A071910-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071910-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071910-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071910-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071910-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071910-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071910-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A071910-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071910-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071910-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071910-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A071910-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A071910-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A071910-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A071910-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A071910-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A071910-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A071910-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A071910-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A071910-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A071910-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A071910-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A071910-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A071910-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A071910-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A071910-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A071910-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A071910-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A071910-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A071910-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A071910-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A071910-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A071910-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A071910-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A071910-001 | AA | 1 | 3a93d1ddd44b… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| SODIUM IODIDE I 123 | SODIUM IODIDE I 123 | Curium US LLC | 493fa2ab-4eb0-4434-9739-3079b2f0e272 | 2024-10-17 | Warnings, Adverse reactions | 69945-601-10 69945-602-20 69945-601 69945-602 69945060220 69945060110 24b19127-9a67-0ddf-e063-6394a90ae0b5 493fa2ab-4eb0-4434-9739-3079b2f0e272 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.