NDC 50914-7731

Megatope

Iodinated I-131 Albumin

Megatope 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 Iodinated I-131 Serum Albumin.

• Product ID: 50914-7731_246defb8-848a-4303-8ab0-d52a1c1bdc8f
• NDC: 50914-7731
• Product Type: Human Prescription Drug
• Proprietary Name: Megatope
• Generic Name: Iodinated I-131 Albumin
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1990-06-01
• Marketing Category: BLA / NDA
• Application Number: BLA017837
• Labeler Name: Iso-Tex Diagnostics, Inc.
• Substance Name: IODINATED I-131 SERUM ALBUMIN
• Active Ingredient Strength: 1 mCi/mL
• Pharm Classes: Radiopharmaceutical Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 50914-7731-4

8 mL in 1 VIAL, MULTI-DOSE (50914-7731-4)

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

NDC SPL Data Element Entries

NDC 50914-7731-4 [50914773104]

Megatope INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017837
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1990-06-01

Drug Details

Active Ingredients

Ingredient	Strength
IODINATED I-131 SERUM ALBUMIN	1 mCi/mL

OpenFDA Data

• SPL SET ID: 62ca4278-8cc9-46b7-8f3c-303ce6a9c155
• Manufacturer:
  • Iso-Tex Diagnostics, Inc.
• UNII:
  • ACH35131L1
• NUI Code:
  • N0000000205

Pharmacological Class

• Radiopharmaceutical Activity [MoA]
• Radiopharmaceutical Activity [MoA]

NDC Crossover Matching brand name "Megatope" or generic name "Iodinated I-131 Albumin"

NDC	Brand Name	Generic Name
50914-7731	Megatope	Iodinated I-131 Albumin
50914-7720	Volumex	Iodinated I-131 Albumin