Home NDC 50914-7732-9 Jeanatope
Product NDC 50914-7732
Requested package NDC 50914-7732-9
11-digit product format 509147732
Labeler code 50914
Product ID 50914-7732_00ad6e0d-58de-41b1-93d1-7ba11ae0bba5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Iodinated I-125 Albumin
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Iso-Tex Diagnostics, Inc.
Application BLA017836
Marketing category BLA
Marketing start 1990-06-01
Marketing end 0000-00-00
Substance HUMAN SERUM ALBUMIN I-125
Active strength 0 mCi/mL
Pharmacologic classes Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IODINATED I-125 SERUM ALBUMIN ACTIVE INGREDIENT 68WQQ3N9TI JEANATOPE (IODINATED I-125 ALBUMIN) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.] 1 IODINATED I-125 SERUM ALBUMIN ACTIVE MOIETY 68WQQ3N9TI JEANATOPE (IODINATED I-125 ALBUMIN) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.] 1 ALBUMIN HUMAN INACTIVE INGREDIENT ZIF514RVZR JEANATOPE (IODINATED I-125 ALBUMIN) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH JEANATOPE (IODINATED I-125 ALBUMIN) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.] 1
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 017836 Jeanatope iodinated I-125 albumin 351(a) Disc 2026-08-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50914-7732-9 50914773209 1 VIAL, MULTI-DOSE in 1 BOX (50914-7732-9) > 11 mL in 1 VIAL, MULTI-DOSE 2004-06-08 0000-00-00 No No Current