Iomeron

Product NDC
76381-740
11-digit product format
763810740
Labeler code
76381
Product ID
76381-740_466579a4-4788-47ad-876a-b0a673f07a72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Iomeprol Injection
Dosage form
INJECTION, SOLUTION
Route
INTRAVASCULAR
Labeler
BIPSO GmbH
Marketing category
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing start
2022-07-01
Substance
IOMEPROL
Active strength
816 mg/mL
Pharmacologic classes
Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage76381-74076381-740-10DDiscontinued by firm2026-08-10

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 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…

Additional Listing Data#

Finished product
Yes
Brand name base
Iomeron
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IOMEPROL816 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
17E17JBP8LInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
30a993a8-9afb-42c2-a4b2-72a6b361d43cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76381-740-10Iomeron10 in 1 BOXINJECTION, SOLUTION105
76381-740-10Iomeron100 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION1005
76381-740-13Iomeron56 in 1 BOXINJECTION, SOLUTION565
76381-740-13Iomeron100 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION1005
76381-740-16Iomeron100 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION1005
76381-740-16Iomeron100 in 1 BOXINJECTION, SOLUTION1005
76381-740-20Iomeron200 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION2005
76381-740-20Iomeron30 in 1 BOXINJECTION, SOLUTION305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76381-740IOMERON (IOMEPROL INJECTION) INJECTION, SOLUTION [BIPSO GMBH]4Current NDC, Legacy NDC, 8 package rows20241215_30a993a8-9afb-42c2-a4b2-72a6b361d43c.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IomeronIOMEPROL INJECTIONBIPSO GmbH30a993a8-9afb-42c2-a4b2-72a6b361d43c2025-11-19Exact identifier
ndc (product): 76381-740

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76381-740-107638107401010 BOTTLE, GLASS in 1 BOX (76381-740-10) > 100 mL in 1 BOTTLE, GLASS2022-07-010000-00-00NoNoCurrent
76381-740-137638107401356 BOTTLE, GLASS in 1 BOX (76381-740-13) / 100 mL in 1 BOTTLE, GLASS2022-07-012026-09-01NoNoCurrent
76381-740-1676381074016100 BOTTLE, GLASS in 1 BOX (76381-740-16) / 100 mL in 1 BOTTLE, GLASS2022-07-012027-01-01NoNoCurrent
76381-740-207638107402030 BOTTLE, GLASS in 1 BOX (76381-740-20) / 200 mL in 1 BOTTLE, GLASS2022-07-012027-02-01NoNoCurrent