Cedax
NDC Package 59630-821-90

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

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

Cedax is (ceftibuten) is indicated for the treatment of individuals with mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES sections).Acute Bacterial Exacerbations of Chronic Bronchitis due to Haemophilus influenzae (including β-lactamase-producing strains), Moraxella catarrhalis (including β-lactamase-producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only). Marketed by Sciele Pharma, Inc., this product is identified by NDC 59630-821 and is authorized under FDA application NDA050686.

Identification & Billing

NDC Package Code
59630-821-90
Package Description
1 BOTTLE in 1 CARTON / 90 mL in 1 BOTTLE
Product Code
59630-821
11-Digit Billing Format
59630082190
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cedax
Dosage Form
-
Usage Information
CEDAX (ceftibuten) is indicated for the treatment of individuals with mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES sections).Acute Bacterial Exacerbations of Chronic Bronchitis due to Haemophilus influenzae (including β-lactamase-producing strains), Moraxella catarrhalis (including β-lactamase-producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only).

Regulatory & Marketing

Labeler Name
Sciele Pharma, Inc.
FDA Application #
NDA050686
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-20-1995
Listing Expiration
12-31-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (59630-821). Click a package code to view its specific billing and regulatory data.

59630-821-12
1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE
59630-821-60
1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE

* 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 59630-821-90 identifies a specific commercial package of 1 bottle in 1 carton / 90 ml in 1 bottle of Cedax, labeled by Sciele Pharma, Inc.. 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 Sciele Pharma, Inc. on December 20, 1995. The current certification is valid through December 31, 2017.

How is this Sciele Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59630082190. 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 (5-3-2)
59630-821-90
11-Digit CMS (5-4-2)
59630-0821-90

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