Ceftriaxone
NDC Package 52584-148-00

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 discontinued by the firm.

Ceftriaxone is used to treat a wide variety of bacterial infections. Marketed by General Injectables And Vaccines, Inc., this product is identified by NDC 52584-148 and is authorized under FDA application ANDA203702.

Identification & Billing

NDC Package Code
52584-148-00
Package Description
1 VIAL, SINGLE-USE in 1 BAG / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE
Product Code
52584-148
11-Digit Billing Format
52584014800

Clinical Specifications

Proprietary Name
Ceftriaxone
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
General Injectables And Vaccines, Inc.
FDA Application #
ANDA203702
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-17-2019
End Marketing Date
08-31-2021
Listing Expiration
08-31-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 52584-148-00 identifies a specific commercial package of 1 vial, single-use in 1 bag / 1 injection, powder, for solution in 1 vial, single-use of Ceftriaxone, labeled by General Injectables And Vaccines, 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 General Injectables And Vaccines, Inc. on May 17, 2019. The current certification is valid through August 31, 2021.

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 General Injectables And Vaccines, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52584014800. 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)
52584-148-00
11-Digit CMS (5-4-2)
52584-0148-00

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