NDC 69208-005

Sodium Iodide I-131

Sodium Iodide I-131

Sodium Iodide I-131 is a Oral Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by International Isotopes Inc. The primary component is Sodium Iodide I-131.

Product ID69208-005_784a0e98-c2ea-f845-e053-2991aa0ac4b4
NDC69208-005
Product TypeHuman Prescription Drug
Proprietary NameSodium Iodide I-131
Generic NameSodium Iodide I-131
Dosage FormSolution, Concentrate
Route of AdministrationORAL
Marketing Start Date2010-09-01
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameInternational Isotopes Inc
Substance NameSODIUM IODIDE I-131
Active Ingredient Strength3500 mCi/mL
Pharm ClassesRadioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 69208-005-15

1 CANISTER in 1 BOX (69208-005-15) > 1 VIAL, DISPENSING in 1 CANISTER > 1 mL in 1 VIAL, DISPENSING
Marketing Start Date2010-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69208-005-70 [69208000570]

Sodium Iodide I-131 SOLUTION, CONCENTRATE
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-09-01

NDC 69208-005-15 [69208000515]

Sodium Iodide I-131 SOLUTION, CONCENTRATE
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-09-01

NDC 69208-005-55 [69208000555]

Sodium Iodide I-131 SOLUTION, CONCENTRATE
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-09-01

NDC 69208-005-25 [69208000525]

Sodium Iodide I-131 SOLUTION, CONCENTRATE
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-09-01

NDC 69208-005-35 [69208000535]

Sodium Iodide I-131 SOLUTION, CONCENTRATE
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-09-01

NDC 69208-005-60 [69208000560]

Sodium Iodide I-131 SOLUTION, CONCENTRATE
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-09-01

Drug Details

Active Ingredients

IngredientStrength
SODIUM IODIDE I-1313500 mCi/mL

OpenFDA Data

SPL SET ID:bc73c28e-a3e2-4a58-8412-c8b7495796b3
Manufacturer
UNII

Pharmacological Class

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

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

NDCBrand NameGeneric Name
69208-000Sodium Iodide I-131Sodium Iodide I-131
69208-005Sodium Iodide I-131Sodium Iodide I-131

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.