Conray Injection
NDC Package 0019-0953-23

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

Conray (iothalamate meglumine) injection is conray is indicated for use in excretory urography, cerebral angiography, peripheral arteriography, venography, arthrography, direct cholangiography, endoscopic retrograde cholangiopancreatography, contrast enhancement of computed tomographic brain images, cranial computerized angiotomography, intravenous digital subtraction angiography and arterial digital subtraction angiography. This formulation utilizes a injection delivery system. Marketed by Liebel-flarsheim Company Llc, this product is identified by NDC 0019-0953 and is authorized under FDA application NDA013295.

Identification & Billing

NDC Package Code
0019-0953-23
Package Description
25 VIAL, GLASS in 1 BOX / 30 mL in 1 VIAL, GLASS
Product Code
0019-0953
11-Digit Billing Format
00019095323
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Conray
Non-Proprietary Name
Iothalamate Meglumine
Substance Name
Iothalamate Meglumine
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravascular - Administration within a vessel or vessels.
Active Ingredient(s)
IOTHALAMATE MEGLUMINE 600 mg/mL
Pharmacologic Class
Usage Information
Conray is indicated for use in excretory urography, cerebral angiography, peripheral arteriography, venography, arthrography, direct cholangiography, endoscopic retrograde cholangiopancreatography, contrast enhancement of computed tomographic brain images, cranial computerized angiotomography, intravenous digital subtraction angiography and arterial digital subtraction angiography. Conray may also be used for enhancement of computed tomographic scans performed for detection and evaluation of lesions in the liver, pancreas, kidneys, abdominal aorta, mediastinum, abdominal cavity and retroperitoneal space. Continuous or multiple scans separated by intervals of 1 to 3 seconds during the first 30 to 90 seconds post-injection of the contrast medium (dynamic CT scanning) may provide enhancement of diagnostic significance, and may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with CT alone, and in supplying additional features of the lesions. In other cases, the contrast agent may allow visualization of lesions not seen with CT alone, or may help to define suspicious lesions seen with unenhanced CT (see CLINICAL PHARMACOLOGY). Subsets of patients in whom delayed body CT scans might be helpful have not been identified. Inconsistent results have been reported and abnormal and normal tissues may be isodense during the time frame used for delayed CT scanning. The risks of such indiscriminate use of contrast media are well known and such use is not recommended. At present, consistent results have been documented using dynamic CT techniques only.

Regulatory & Marketing

Labeler Name
Liebel-flarsheim Company Llc
Product Type
Human Prescription Drug
FDA Application #
NDA013295
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-14-2003
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 (0019-0953). Click a package code to view its specific billing and regulatory data.

0019-0953-05
25 VIAL, GLASS in 1 BOX / 50 mL in 1 VIAL, GLASS
0019-0953-10
12 BOTTLE, GLASS in 1 BOX / 100 mL in 1 BOTTLE, GLASS
0019-0953-50
12 BOTTLE, GLASS in 1 BOX / 150 mL in 1 BOTTLE, GLASS

* 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 0019-0953-23 identifies a specific commercial package of 25 vial, glass in 1 box / 30 ml in 1 vial, glass of Conray, a human prescription drug labeled by Liebel-flarsheim Company Llc. This injection is formulated for intravascular use and contains iothalamate meglumine 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 Liebel-flarsheim Company Llc on October 14, 2003. The current certification is valid through December 31, 2026.

How is this Liebel-flarsheim Company Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00019095323. 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 (4-4-2)
0019-0953-23
11-Digit CMS (5-4-2)
00019-0953-23

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