Iopamidol Injection, Solution
NDC Package 68225-077-41

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Iopamidol injection is a medication used before X-ray imaging tests (such as CT scans). This formulation utilizes a injection, solution delivery system. Marketed by Patheon Italia S.p.a., this product is identified by NDC 68225-077.

Identification & Billing

NDC Package Code
68225-077-41
Package Description
60 BOX in 1 CASE / 10 BOTTLE in 1 BOX / 200 mL in 1 BOTTLE
Product Code
68225-077
11-Digit Billing Format
68225007741

Clinical Specifications

Proprietary Name
Iopamidol
Non-Proprietary Name
Iopamidol
Substance Name
Iopamidol
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Active Ingredient(s)
IOPAMIDOL 612 mg/mL
Usage Information
This medication is used before X-ray imaging tests (such as CT scans). Iohexol contains iodine and belongs to a class of drugs known as contrast media or dyes. It works by adding contrast to body parts and fluids in these imaging tests. Iohexol improves the images obtained during a CT scan, so your doctor can more easily diagnose your condition.

Regulatory & Marketing

Labeler Name
Patheon Italia S.p.a.
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
12-31-1985
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68225-077). Click a package code to view its specific billing and regulatory data.

68225-077-10
112 BOX in 1 CASE / 10 BOTTLE in 1 BOX / 100 mL in 1 BOTTLE
68225-077-50
198 BOX in 1 CONTAINER / 10 VIAL in 1 BOX / 50 mL in 1 VIAL
68225-077-98
6 BOTTLE in 1 BOX / 500 mL in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68225-077-41 identifies a specific commercial package of 60 box in 1 case / 10 bottle in 1 box / 200 ml in 1 bottle of Iopamidol (UNFINISHED drug), drug for further processing labeled by Patheon Italia S.p.a.. This injection, solution is formulated for use and contains iopamidol as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Patheon Italia S.p.a. on December 31, 1985. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used before X-ray imaging tests (such as CT scans). Iohexol contains iodine and belongs to a class of drugs known as contrast media or dyes. It works by adding contrast to body parts and fluids in these imaging tests. Iohexol improves the images obtained during a CT scan, so your doctor can more easily diagnose your condition.

How is this Patheon Italia S.p.a. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68225007741. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
68225-077-41
11-Digit CMS (5-4-2)
68225-0077-41

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.