NDC Package 59630-821-60 Cedax

View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

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

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

59630-821-60

Package Description:

1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE

Product Code:

59630-821

Proprietary Name:

Cedax

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).

11-Digit NDC Billing Format:

59630082160

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

RxCUI: 108395 - Cedax 400 MG Oral Capsule

RxCUI: 108395 - ceftibuten 400 MG Oral Capsule [Cedax]

RxCUI: 309086 - ceftibuten 400 MG Oral Capsule

RxCUI: 309086 - ceftibuten (as ceftibuten dihydrate) 400 mg Oral Capsule

RxCUI: 309087 - ceftibuten 90 MG in 5 mL Oral Suspension

Labeler Name:

Sciele Pharma, Inc.

Sample Package:

Start Marketing Date:

12-20-1995

Listing Expiration Date:

12-31-2017

Exclude Flag:

Code Structure:

59630 - Sciele Pharma, Inc.
- 59630-821 - Cedax
  - 59630-821-60 - 1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
59630-821-12	1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE
59630-821-90	1 BOTTLE in 1 CARTON / 90 mL in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 59630-821-60?

The NDC Packaged Code 59630-821-60 is assigned to a package of 1 bottle in 1 carton / 60 ml in 1 bottle of Cedax, labeled by Sciele Pharma, Inc.. The product's dosage form is and is administered via form.

Is NDC 59630-821 included in the NDC Directory?

No, Cedax with product code 59630-821 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Sciele Pharma, Inc. on December 20, 1995 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 59630-821-60?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 59630-821-60?

The 11-digit format is 59630082160. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	59630-821-60	5-4-2	59630-0821-60

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