Rocephin
NDC Package 0004-1963-01

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.

Rocephin is ceftriaxone is used to treat a wide variety of bacterial infections. Marketed by Genentech, Inc., this product is identified by NDC 0004-1963 and is authorized under FDA application ANDA063239.

Identification & Billing

NDC Package Code
0004-1963-01
Package Description
10 VIAL, GLASS in 1 BOX / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
Product Code
0004-1963
11-Digit Billing Format
00004196301
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA

Clinical Specifications

Proprietary Name
Rocephin
Dosage Form
-
Usage Information
Ceftriaxone is used to treat a wide variety of bacterial infections. This medication belongs to a class of drugs known as cephalosporin antibiotics. It works by stopping the growth of bacteria. This drug is not recommended for use in newborns with high blood bilirubin levels and premature infants due to increased risk of side effects. Ask the doctor or pharmacist for details.

Regulatory & Marketing

Labeler Name
Genentech, Inc.
FDA Application #
ANDA063239
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-13-1993
End Marketing Date
07-31-2015
Listing Expiration
07-31-2015
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 (0004-1963). Click a package code to view its specific billing and regulatory data.

0004-1963-02
1 VIAL, GLASS in 1 BOX / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, 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 0004-1963-01 identifies a specific commercial package of 10 vial, glass in 1 box / 1 injection, powder, for solution in 1 vial, glass of Rocephin, labeled by Genentech, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 10 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 Genentech, Inc. on August 13, 1993. The current certification is valid through July 31, 2015.

What are the primary indications for this medication?

Ceftriaxone is used to treat a wide variety of bacterial infections. This medication belongs to a class of drugs known as cephalosporin antibiotics. It works by stopping the growth of bacteria. This drug is not recommended for use in newborns with high blood bilirubin levels and premature infants due to increased risk of side effects. Ask the doctor or pharmacist for details.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00004196301. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 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 (4-4-2)
0004-1963-01
11-Digit CMS (5-4-2)
00004-1963-01

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