Conex
NDC Package 54859-802-16

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Conex is other Information: Store at controlled room temperature 20-25 degree celcius ( 68-77 degree farenheit); excursions permitted to 15-30 degree clecius (59-86 degree farenheit) (See USP Controlled Room Temperture) Tamper evident by imprinted heat seal under capDo not use if there is evidence of tamperingWARNING: Phenylketonuric: Contains 13.5 mg of Phenylalanine per 5 mL (one teaspoonful) dose. Marketed by Llorens Pharmaceutical International Division, this product is identified by NDC 54859-802 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
54859-802-16
Package Description
473 mL in 1 BOTTLE
Product Code
54859-802
11-Digit Billing Format
54859080216
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML

Clinical Specifications

Proprietary Name
Conex
Dosage Form
-
Usage Information
Other Information: Store at controlled room temperature 20-25 degree celcius ( 68-77 degree farenheit); excursions permitted to 15-30 degree clecius (59-86 degree farenheit) (See USP Controlled Room Temperture) Tamper evident by imprinted heat seal under capDo not use if there is evidence of tamperingWARNING: Phenylketonuric: Contains 13.5 mg of Phenylalanine per 5 mL (one teaspoonful) dose.

Regulatory & Marketing

Labeler Name
Llorens Pharmaceutical International Division
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-01-2007
Listing Expiration
12-31-2025
Exclude Flag
I
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 54859-802-16 identifies a specific commercial package of 473 ml in 1 bottle of Conex, labeled by Llorens Pharmaceutical International Division. This product is billed per "ML" milliliter and contains an estimated amount of 473 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Llorens Pharmaceutical International Division on November 01, 2007. The current certification is valid through December 31, 2025.

How is this Llorens Pharmaceutical International Division product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54859080216. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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)
54859-802-16
11-Digit CMS (5-4-2)
54859-0802-16

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