FDA.reportPublic FDA data

Jeanatope

Product NDC
50914-7732
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50914-7732DDiscontinued by firm2026-09-14
excluded packagepackage50914-773250914-7732-5DDiscontinued by firm2026-09-14
excluded packagepackage50914-773250914-7732-9DDiscontinued by firm2026-09-14

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 · 27 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50914-7732-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50914-7732-5d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50914-7732-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50914-7732-5f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50914-7732-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50914-7732-52ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50914-7732-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50914-7732-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50914-7732-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50914-7732-5cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50914-7732-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50914-7732-5cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50914-7732-9302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50914-7732-5302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50914-7732-9ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50914-7732-5ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50914-7732-90efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50914-7732-50efc9e666f02…f202fb6c5f17…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IODINATED I-125 SERUM ALBUMINACTIVE INGREDIENT68WQQ3N9TIJEANATOPE (IODINATED I-125 ALBUMIN) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.]1
IODINATED I-125 SERUM ALBUMINACTIVE MOIETY68WQQ3N9TIJEANATOPE (IODINATED I-125 ALBUMIN) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.]1
ALBUMIN HUMANINACTIVE INGREDIENTZIF514RVZRJEANATOPE (IODINATED I-125 ALBUMIN) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHJEANATOPE (IODINATED I-125 ALBUMIN) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.]1

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
017836Jeanatopeiodinated I-125 albumin351(a)Disc2026-08-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50914-7732-5509147732051 VIAL, MULTI-DOSE in 1 BOX (50914-7732-5) > 11 mL in 1 VIAL, MULTI-DOSE1990-06-010000-00-00NoNoCurrent
50914-7732-9509147732091 VIAL, MULTI-DOSE in 1 BOX (50914-7732-9) > 11 mL in 1 VIAL, MULTI-DOSE2004-06-080000-00-00NoNoCurrent