Cervarix
NDC Package 58160-830-52

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 discontinued by the firm.

Cervarix is a . Marketed by Glaxosmithkline Biologicals Sa, this product is identified by NDC 58160-830 and is authorized under FDA application BLA125259.

Identification & Billing

NDC Package Code
58160-830-52
Package Description
10 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (58160-830-43)
Product Code
58160-830
11-Digit Billing Format
58160083052
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Cervarix
Dosage Form
-

Regulatory & Marketing

Labeler Name
Glaxosmithkline Biologicals Sa
FDA Application #
BLA125259
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
10-16-2009
End Marketing Date
11-29-2016
Listing Expiration
11-29-2016
Exclude Flag
D
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 (58160-830). Click a package code to view its specific billing and regulatory data.

58160-830-34
1 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (58160-830-05)

* 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 58160-830-52 identifies a specific commercial package of 10 syringe in 1 carton / .5 ml in 1 syringe (58160-830-43) of Cervarix, labeled by Glaxosmithkline Biologicals Sa. 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 Glaxosmithkline Biologicals Sa on October 16, 2009. The current certification is valid through November 29, 2016.

How is this Glaxosmithkline Biologicals Sa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58160083052. 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)
58160-830-52
11-Digit CMS (5-4-2)
58160-0830-52

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