NDC 50914-7720

Volumex

Iodinated I-131 Albumin

Volumex 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-131.

• Product ID: 50914-7720_1f46b3df-897f-4a96-9feb-9e5c9dd2864f
• NDC: 50914-7720
• Product Type: Human Prescription Drug
• Proprietary Name: Volumex
• Generic Name: Iodinated I-131 Albumin
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1993-08-01
• Marketing Category: BLA / NDA
• Application Number: BLA017837
• Labeler Name: Iso-Tex Diagnostics, Inc.
• Substance Name: HUMAN SERUM ALBUMIN I-131
• Active Ingredient Strength: 0 mCi/mL
• Pharm Classes: Radiopharmaceutical Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 50914-7720-8

1 mL in 1 SYRINGE, PLASTIC (50914-7720-8)

• Marketing Start Date: 1993-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50914-7720-8 [50914772008]

Volumex INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017837
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1993-08-01

Drug Details

Active Ingredients

Ingredient	Strength
IODINATED I-131 SERUM ALBUMIN	.025 mCi/mL

OpenFDA Data

• SPL SET ID: 812240e4-fc28-46c2-92f3-1ba4e029645a
• Manufacturer:
  • Iso-Tex Diagnostics, Inc.
• UNII:
  • ACH35131L1
• NUI Code:
  • N0000000205

Pharmacological Class

• Radiopharmaceutical Activity [MoA]

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

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