Omnipaque Injection, Solution
NDC Package 71872-7369-1

11-digit billing NDC: 71872736901
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Omnipaque (iohexol) injection is oMNIPAQUE injection 300 mg iodine/mL and OMNIPAQUE injection 350 mg iodine/mL in 500 mL bottles may be used as an Imaging Bulk Package (IBP) for intravenous use [see Dosage and Administration (2.4, 2.8)]. This formulation utilizes a injection, solution delivery system. Marketed by Medical Purchasing Solutions, Llc, this product is identified by NDC 71872-7369 and is authorized under FDA application NDA018956.

Identification & Billing

NDC Package Code
71872-7369-1
Package Description
1 BOTTLE, PLASTIC in 1 BAG / 50 mL in 1 BOTTLE, PLASTIC
Product Code
71872-7369
11-Digit Billing Format
71872736901

Clinical Specifications

Proprietary Name
Omnipaque
Non-Proprietary Name
Iohexol
Substance Name
Iohexol
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
  • Intra-articular - Administration within a joint.
  • Intrathecal - Administration within the cerebrospinal fluid at any level of the cerebrospinal axis, including injection into the cerebral ventricles.
  • Intravascular - Administration within a vessel or vessels.
  • Intravenous - Administration within or into a vein or veins.
  • Oral - Administration to or by way of the mouth.
  • Rectal - Administration to the rectum.
Active Ingredient(s)
IOHEXOL 240 mg/mL
Pharmacologic Class
Usage Information
OMNIPAQUE injection 300 mg iodine/mL and OMNIPAQUE injection 350 mg iodine/mL in 500 mL bottles may be used as an Imaging Bulk Package (IBP) for intravenous use [see Dosage and Administration (2.4, 2.8)] . When used as an IBP, check the appropriate box on the container label to indicate that the selected container is to be utilized as an Imaging Bulk Package. This container is for use only with an automated contrast injection system, contrast management system, or contrast media transfer set approved or cleared for use with this contrast agent in this IBP. See device labeling for information on devices indicated for use with this IBP and techniques to help assure safe use.Use the OMNIPAQUE IBP and 0.9% Sodium Chloride Injection USP in a room designated for radiological procedures that involve administration of a contrast agent.Using aseptic technique, penetrate the container closure only one time with a suitable sterile component of the automated contrast injection system, contrast management system, or contrast media transfer set cleared for use with the OMNIPAQUE IBP.If 0.9% Sodium Chloride Injection USP is used with the OMNIPAQUE IBP, prepare the 0.9% Sodium Chloride Injection USP sterile port in accordance with the dosage and administration section of its approved prescribing information and affix the saline tag provided with the OMNIPAQUE IBP on the 0.9% Sodium Chloride Injection USP container.Once the OMNIPAQUE IBP and 0.9% Sodium Chloride Injection containers are punctured, do not remove them from the work area during the entire period of use. Maintain the OMNIPAQUE IBP in an inverted position such that container contents are in continuous contact with the dispensing set.After the container closure is punctured, if the integrity of the OMNIPAQUE IBP, the 0.9% Sodium Chloride Injection, and the delivery system cannot be assured through direct continuous supervision, discard the IBP, 0.9% Sodium Chloride Injection USP, and all associated disposables for the contrast media transfer set.A maximum time from initial puncture is 8 hours. Discard any unused portion.

Regulatory & Marketing

Labeler Name
Medical Purchasing Solutions, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA018956
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-26-1985
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71872-7369-1 identifies a specific commercial package of 1 bottle, plastic in 1 bag / 50 ml in 1 bottle, plastic of Omnipaque, a human prescription drug labeled by Medical Purchasing Solutions, Llc. This injection, solution is formulated for intra-articular; intrathecal; intravascular; intravenous; oral; rectal use and contains iohexol 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 Medical Purchasing Solutions, Llc on December 26, 1985. The current certification is valid through December 31, 2027.

How is this Medical Purchasing Solutions, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71872736901. 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 (5-4-1)
71872-7369-1
11-Digit CMS (5-4-2)
71872-7369-01

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