NDC 50914-7729

Glofil-125

Sodium Iothalamate I-125 Injection

Glofil-125 is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Iso-tex Diagnostics, Inc.. The primary component is Iothalamate Sodium I-125.

• Product ID: 50914-7729_03a98b4c-213b-4537-8d3a-aaa9f9f1cc9b
• NDC: 50914-7729
• Product Type: Human Prescription Drug
• Proprietary Name: Glofil-125
• Generic Name: Sodium Iothalamate I-125 Injection
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1983-05-01
• Marketing Category: NDA / NDA
• Application Number: NDA017279
• Labeler Name: Iso-Tex Diagnostics, Inc.
• Substance Name: IOTHALAMATE SODIUM I-125
• Active Ingredient Strength: 0 mCi/mL
• Pharm Classes: Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50914-7729-2

1 VIAL, MULTI-DOSE in 1 BOX (50914-7729-2) > 4 mL in 1 VIAL, MULTI-DOSE

• Marketing Start Date: 1983-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50914-7729-2 [50914772902]

Glofil-125 INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017279
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1983-05-01

Drug Details

Active Ingredients

Ingredient	Strength
IOTHALAMATE SODIUM I-125	.275 mCi/mL

OpenFDA Data

• SPL SET ID: 7f250086-2837-484b-9674-e09856b34cb0
• Manufacturer:
  • Iso-Tex Diagnostics, Inc.
• UNII:
  • 31J5U3Q9ZN
• UPC Code:
  • 0050914772920

Pharmacological Class

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