Lipiodol Injection
NDC Package 67684-1901-2

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

Lipiodol (ethiodized oil) injection is lipiodol is an oil-based radio-opaque contrast agent indicated for:hysterosalpingography in adultslymphography in adult and pediatric patientsselective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC). This formulation utilizes a injection delivery system. Marketed by Guerbet Llc, this product is identified by NDC 67684-1901 and is authorized under FDA application NDA009190.

Identification & Billing

NDC Package Code
67684-1901-2
Package Description
1 VIAL in 1 CARTON / 10 mL in 1 VIAL
Product Code
67684-1901
11-Digit Billing Format
67684190102
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Lipiodol
Non-Proprietary Name
Ethiodized Oil
Substance Name
Ethiodized Oil
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Intra-arterial - Administration within an artery or arteries.
  • Intralymphatic - Administration within the lymph.
  • Intrauterine - Administration within the uterus.
Active Ingredient(s)
ETHIODIZED OIL 480 mg/mL
Usage Information
Lipiodol is an oil-based radio-opaque contrast agent indicated for:hysterosalpingography in adultslymphography in adult and pediatric patientsselective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC)

Regulatory & Marketing

Labeler Name
Guerbet Llc
Product Type
Human Prescription Drug
FDA Application #
NDA009190
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-21-2014
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 (67684-1901). Click a package code to view its specific billing and regulatory data.

67684-1901-0
1 AMPULE in 1 CARTON / 10 mL in 1 AMPULE
67684-1901-1
1 AMPULE in 1 CARTON / 10 mL in 1 AMPULE

* 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 67684-1901-2 identifies a specific commercial package of 1 vial in 1 carton / 10 ml in 1 vial of Lipiodol, a human prescription drug labeled by Guerbet Llc. This injection is formulated for intra-arterial; intralymphatic; intrauterine use and contains ethiodized oil 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 Guerbet Llc on March 21, 2014. The current certification is valid through December 31, 2026.

How is this Guerbet Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67684190102. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
67684-1901-2
11-Digit CMS (5-4-2)
67684-1901-02

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