Home NDC 50914-7720 Volumex
Product NDC 50914-7720
11-digit product format 509147720
Labeler code 50914
Product ID 50914-7720_1f46b3df-897f-4a96-9feb-9e5c9dd2864f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Iodinated I-131 Albumin
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Iso-Tex Diagnostics, Inc.
Application BLA017837
Marketing category BLA
Marketing start 1993-08-01
Substance HUMAN SERUM ALBUMIN I-131
Active strength .025 mCi/mL
Pharmacologic classes Radiopharmaceutical Activity [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Volumex
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HUMAN SERUM ALBUMIN I-131 .025 mCi/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ACH35131L1 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50914-7720-8 Volumex 1 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 1 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IODINATED I-131 SERUM ALBUMIN ACTIVE INGREDIENT ACH35131L1 VOLUMEX (IODINATED I-131 ALBUMIN ) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.] 1 IODINATED I-131 SERUM ALBUMIN ACTIVE MOIETY ACH35131L1 VOLUMEX (IODINATED I-131 ALBUMIN ) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.] 1 ALBUMIN HUMAN INACTIVE INGREDIENT ZIF514RVZR VOLUMEX (IODINATED I-131 ALBUMIN ) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH VOLUMEX (IODINATED I-131 ALBUMIN ) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50914-7720 VOLUMEX (IODINATED I-131 ALBUMIN ) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20221126_812240e4-fc28-46c2-92f3-1ba4e029645a.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 017837 Megatope iodinated I-131 albumin 351(a) Disc 2026-08-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50914-7720-8 50914772008 1 mL in 1 SYRINGE, PLASTIC (50914-7720-8) 1 ml 1993-08-01 0000-00-00 No No Current