Iopamidol Injection, Solution
NDC Package 70436-124-35

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

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 Slate Run Pharmaceuticals, this product is identified by NDC 70436-124 and is authorized under FDA application ANDA215382.

Identification & Billing

NDC Package Code
70436-124-35
Package Description
20 mL in 1 VIAL, SINGLE-DOSE
Product Code
70436-124
11-Digit Billing Format
70436012435
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
20 ML

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.
Administration Route
Intrathecal - Administration within the cerebrospinal fluid at any level of the cerebrospinal axis, including injection into the cerebral ventricles.
Active Ingredient(s)
IOPAMIDOL 408 mg/mL
Pharmacologic Class
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
Slate Run Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
ANDA215382
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-20-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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 (70436-124). Click a package code to view its specific billing and regulatory data.

70436-124-33
10 mL in 1 VIAL, SINGLE-DOSE
70436-124-52
200 mL in 1 CARTON
70436-124-82
100 mL in 1 CARTON

* 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 70436-124-35 identifies a specific commercial package of 20 ml in 1 vial, single-dose of Iopamidol, a human prescription drug labeled by Slate Run Pharmaceuticals. This product is billed per "ML" milliliter and contains an estimated amount of 20 billable units per package. This injection, solution is formulated for intrathecal 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 Slate Run Pharmaceuticals on July 20, 2023. 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 Slate Run Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70436012435. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 20 total billable units per package. 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)
70436-124-35
11-Digit CMS (5-4-2)
70436-0124-35

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