FDA.reportPublic FDA data

NDC 69208-003-15 - Sodium Iodide I-131

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
69208-003
Requested NDC
69208-003-15
Package NDCs from labels
69208-003-15, 69208-003-25, 69208-003-35
Manufacturer
Radnostix, Inc.
Effective date
2026-01-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sodium Iodide I-131 - Radnostix, Inc.Radnostix, Inc.2026-01-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69208-003SODIUM IODIDE I-131 KIT [INTERNATIONAL ISOTOPES INC]7Unmatched20240110_380e8e26-0625-4233-b36e-afb9f66e8a77.zip

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ThiosulfateSODIUM THIOSULFATEHope Pharmaceuticals82f55408-2de9-463d-85e8-b39c3b259f0b2026-05-26Warnings, Adverse reactionsExact identifier
unii: HX1032V43M
Sodium PhosphatesSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC, ANHYDROUSHospira, Inc.6f044d16-295e-43ff-72a3-b045c387bc5c2026-05-11Warnings, Adverse reactionsExact identifier
unii: 22ADO53M6F
Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium PhosphateDIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATERising Pharma Holdings, Inc.b01eac95-dbe3-4b21-a922-187e0fc8ad232026-04-07Adverse reactionsExact identifier
unii: 22ADO53M6F
PHOSPHA 250 NEUTRALDIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATERising Pharma Holdings, Inc.9432adfc-6add-4ab4-ae93-2e2daf348be22026-03-25Adverse reactionsExact identifier
unii: 22ADO53M6F
Sodium Iodide I-131SODIUM IODIDE I-131Radnostix, Inc.380e8e26-0625-4233-b36e-afb9f66e8a772026-01-23Warnings, Adverse reactionsExact identifier
application number: ANDA209166
ndc (package): 69208-000-00
ndc (package): 69208-003-15
ndc (package): 69208-003-25
ndc (package): 69208-003-35
ndc (product): 69208-000
ndc11 (package): 69208000315
spl id: 490fdcc0-a035-b6f8-e063-6394a90a28a5
spl set id: 380e8e26-0625-4233-b36e-afb9f66e8a77
PEDMARKSODIUM THIOSULFATEFennec Pharmaceuticals Inc.f98c7076-2a7b-4fd7-ab90-eed5e9137bae2025-10-27Warnings, Adverse reactionsExact identifier
unii: HX1032V43M
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltd9083a01b-2fbe-4e04-9eec-bf4f65950ec72025-09-09WarningsExact identifier
unii: 22ADO53M6F
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM ,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltdc14c79ab-85bb-45f2-83d1-1d9c298ffdfd2025-09-08WarningsExact identifier
unii: 22ADO53M6F
Schuessler Tissue Salts Comb 5 Nerve TonicCALCAREA PHOSPHORICA,MAGNESIA PHOSPHORICA,FERRUM PHOSPHORICUM ,NATRUM PHOSPHORICUM,KALI PHOSPHORICUMMartin & Pleasance Pty Ltd7fd350ec-af99-4eb2-8750-226edc7f24b02025-08-13WarningsExact identifier
unii: 22ADO53M6F
Schuessler Tissue Salts Comb 5 Nerve TonicCALCAREA PHOSPHORICA ,MAGNESIA PHOSPHORICA,FERRUM PHOSPHORICUM,NATRUM PHOSPHORICUM,KALI PHOSPHORICUMMartin & Pleasance Pty Ltdc0df631e-2935-4d55-a3c9-ee04ffdbe6fd2025-08-13WarningsExact identifier
unii: 22ADO53M6F
Sodium PhosphatesSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC ANHYDROUSCivica, Inc.8fd901e6-30cb-411a-b820-b9e79625ec7c2025-08-08Warnings, Adverse reactionsExact identifier
unii: 22ADO53M6F
Schuessler Tissue Salts Nat Phos Acid Neutralizer 10NATRUM PHOSPHORICUMMartin & Pleasance Pty Ltd82cb0ce1-8e56-4721-9ff9-31e66c912c602025-08-04WarningsExact identifier
unii: 22ADO53M6F
Schuessler Tissue Salts Nat Phos Acid Neutralizer 10NATRUM PHOSPHORICUMMartin & Pleasance Pty Ltd5a230b57-36dc-4aad-a0d4-0f5bb2dcf27c2025-07-07WarningsExact identifier
unii: 22ADO53M6F
HICONSODIUM IODIDE I 131Jubilant DraxImage Inc., dba Jubilant Radiopharma524a0dac-6e2b-2c0c-04b4-76d85dba63c52025-01-21Warnings, Adverse reactionsExact identifier
unii: 29VCO8ACHH
Sodium PhosphatesSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC ANHYDROUSAmerican Regent, Inc.dc0462ee-4486-418c-865f-e2a71bdb8e9e2024-06-06Warnings, Adverse reactionsExact identifier
unii: 22ADO53M6F
Monobasic Sodium Phosphate and Dibasic Sodium PhosphateMONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATELupin Pharmaceuticals,Inc.e2fcc382-6fac-4438-ad02-ebc8528dd59a2024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 22ADO53M6F
K Phos NeutralSODIUM PHOSPHATE, DIBASIC, ANHYDROUS, POTASSIUM PHOSPHATE, MONOBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEBeach Products, Inc.83376725-ee0f-40ad-bd90-31a61b9445cf2023-02-23Adverse reactionsExact identifier
unii: 22ADO53M6F
NAT. PHOS.SODIUM PHOSPHATE, DIBASIC, ANHYDROUSHyland's Inc.9ad86f9f-df9e-4e5c-bce4-571e1da441452022-12-19WarningsExact identifier
unii: 22ADO53M6F
Sodium PhosphatesSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC, ANHYDROUSFresenius Kabi USA, LLC5bf47be3-f3fe-452b-8113-9417964983452022-03-31Warnings, Adverse reactionsExact identifier
unii: 22ADO53M6F
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: 7FLD91C86K

Reported adverse events (FAERS/openFDA)#

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