hicon

Generic: sodium iodide i 131

Labeler: jubilant draximage inc., dba jubilant radiopharma
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name hicon
Generic Name sodium iodide i 131
Labeler jubilant draximage inc., dba jubilant radiopharma
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

sodium iodide i-131 1000 mCi/mL

Manufacturer
Jubilant DraxImage Inc., dba Jubilant Radiopharma

Identifiers & Regulatory

Product NDC 65174-880
Product ID 65174-880_4e98b8e6-01d4-48e8-87c4-7c6867279fa4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021305
Listing Expiration 2026-12-31
Marketing Start 2003-04-07

Pharmacologic Class

Classes
radioactive therapeutic agent [epc] radiopharmaceutical activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65174880
Hyphenated Format 65174-880

Supplemental Identifiers

UNII
29VCO8ACHH

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name hicon (source: ndc)
Generic Name sodium iodide i 131 (source: ndc)
Application Number NDA021305 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mCi/mL
source: ndc
Packaging
  • 1 VIAL in 1 KIT (65174-880-00) / 1 mL in 1 VIAL
  • 1 VIAL in 1 KIT (65174-880-25) / .25 mL in 1 VIAL
  • 1 VIAL in 1 KIT (65174-880-50) / .5 mL in 1 VIAL
source: ndc

Packages (3)

65174-880-00 1 VIAL in 1 KIT (65174-880-00) / 1 mL in 1 VIAL 65174-880-25 1 VIAL in 1 KIT (65174-880-25) / .25 mL in 1 VIAL 65174-880-50 1 VIAL in 1 KIT (65174-880-50) / .5 mL in 1 VIAL

Ingredients (1)

sodium iodide i-131 (1000 mCi/mL)

Linked Drug Pages (1)

HICON ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4e98b8e6-01d4-48e8-87c4-7c6867279fa4", "openfda": {"unii": ["29VCO8ACHH"], "spl_set_id": ["524a0dac-6e2b-2c0c-04b4-76d85dba63c5"], "manufacturer_name": ["Jubilant DraxImage Inc., dba Jubilant Radiopharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 KIT (65174-880-00)  / 1 mL in 1 VIAL", "package_ndc": "65174-880-00", "marketing_start_date": "20030407"}, {"sample": false, "description": "1 VIAL in 1 KIT (65174-880-25)  / .25 mL in 1 VIAL", "package_ndc": "65174-880-25", "marketing_start_date": "20030407"}, {"sample": false, "description": "1 VIAL in 1 KIT (65174-880-50)  / .5 mL in 1 VIAL", "package_ndc": "65174-880-50", "marketing_start_date": "20030407"}], "brand_name": "HICON", "product_id": "65174-880_4e98b8e6-01d4-48e8-87c4-7c6867279fa4", "dosage_form": "SOLUTION", "pharm_class": ["Radioactive Therapeutic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "65174-880", "generic_name": "Sodium Iodide I 131", "labeler_name": "Jubilant DraxImage Inc., dba Jubilant Radiopharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HICON", "active_ingredients": [{"name": "SODIUM IODIDE I-131", "strength": "1000 mCi/mL"}], "application_number": "NDA021305", "marketing_category": "NDA", "marketing_start_date": "20030407", "listing_expiration_date": "20261231"}