NDC 50914-7732

Jeanatope

Iodinated I-125 Albumin

Jeanatope 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 Human Serum Albumin I-125.

• Product ID: 50914-7732_00ad6e0d-58de-41b1-93d1-7ba11ae0bba5
• NDC: 50914-7732
• Product Type: Human Prescription Drug
• Proprietary Name: Jeanatope
• Generic Name: Iodinated I-125 Albumin
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1990-06-01
• Marketing Category: BLA / NDA
• Application Number: BLA017836
• Labeler Name: Iso-Tex Diagnostics, Inc.
• Substance Name: HUMAN SERUM ALBUMIN I-125
• Active Ingredient Strength: 0 mCi/mL
• Pharm Classes: Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 50914-7732-5

1 VIAL, MULTI-DOSE in 1 BOX (50914-7732-5) > 11 mL in 1 VIAL, MULTI-DOSE

• Marketing Start Date: 1990-06-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50914-7732-9 [50914773209]

Jeanatope INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017836
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2004-06-08

NDC 50914-7732-5 [50914773205]

Jeanatope INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017836
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1990-06-01

Drug Details

Active Ingredients

Ingredient	Strength
IODINATED I-125 SERUM ALBUMIN	.01 mCi/mL

OpenFDA Data

• SPL SET ID: 7b6f6a5e-f456-4db9-a3da-44d870ee6547
• Manufacturer:
  • Iso-Tex Diagnostics, Inc.
• UNII:
  • 68WQQ3N9TI
• PHarm Class EPC:
  • Radioactive Diagnostic Agent [EPC]
• NUI Code:
  • N0000000205
  • N0000177914

Pharmacological Class

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

NDC Crossover Matching brand name "Jeanatope" or generic name "Iodinated I-125 Albumin"

NDC	Brand Name	Generic Name
50914-7732	Jeanatope	Iodinated I-125 Albumin
50914-7733	Jeanatope	Iodinated I-125 Albumin