NDC 65174-880

HICON

Sodium Iodide I 131

HICON is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Jubilant Draximage Inc., Dba Jubilant Radiopharma. The primary component is Sodium Iodide I-131.

• Product ID: 65174-880_1cdbe390-ab5c-4dc5-8780-40ac4ff9d5d7
• NDC: 65174-880
• Product Type: Human Prescription Drug
• Proprietary Name: HICON
• Generic Name: Sodium Iodide I 131
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2003-04-07
• Marketing Category: NDA / NDA
• Application Number: NDA021305
• Labeler Name: Jubilant DraxImage Inc., dba Jubilant Radiopharma
• Substance Name: SODIUM IODIDE I-131
• Active Ingredient Strength: 1 mCi/mL
• Pharm Classes: Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 65174-880-00

1 VIAL in 1 KIT (65174-880-00) > 1 mL in 1 VIAL

• Marketing Start Date: 2003-04-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65174-880-50 [65174088050]

HICON SOLUTION

• Marketing Category: NDA
• Application Number: NDA021305
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2003-04-07

NDC 65174-880-00 [65174088000]

HICON SOLUTION

• Marketing Category: NDA
• Application Number: NDA021305
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2003-04-07

NDC 65174-880-25 [65174088025]

HICON SOLUTION

• Marketing Category: NDA
• Application Number: NDA021305
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2003-04-07

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM IODIDE I-131	1 mCi/mL

OpenFDA Data

• SPL SET ID: 524a0dac-6e2b-2c0c-04b4-76d85dba63c5
• Manufacturer:
  • Jubilant DraxImage Inc.
• UNII:
  • 29VCO8ACHH

Pharmacological Class

• Radioactive Therapeutic Agent [EPC]
• Radiopharmaceutical Activity [MoA]
• Radioactive Therapeutic Agent [EPC]
• Radiopharmaceutical Activity [MoA]

NDC Crossover Matching brand name "HICON" or generic name "Sodium Iodide I 131"

NDC	Brand Name	Generic Name
65174-880	HICON	Sodium Iodide I 131
65174-461	Sodium Iodide I 131 Diagnostic	Sodium Iodide I 131