Ceftaroline Fosamil Injection, Powder, Lyophilized, For Solution
NDC Package 60505-4946-1

11-digit billing NDC: 60505494601
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Ceftaroline Fosamil injection is ceftaroline fosamil for injection is indicated in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca [see Dosage and Administration (2.2) and Use in Specific Populations (8.4)]. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Apotex Corp., this product is identified by NDC 60505-4946 and is authorized under FDA application ANDA208075.

Identification & Billing

NDC Package Code
60505-4946-1
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE (60505-4946-0)
Product Code
60505-4946
11-Digit Billing Format
60505494601

Clinical Specifications

Proprietary Name
Ceftaroline Fosamil
Non-Proprietary Name
Ceftaroline Fosamil
Substance Name
Ceftaroline Fosamil
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
CEFTAROLINE FOSAMIL 400 mg/20mL
Pharmacologic Class
Usage Information
Ceftaroline fosamil for injection is indicated in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca [see Dosage and Administration (2.2) and Use in Specific Populations (8.4)].  

Regulatory & Marketing

Labeler Name
Apotex Corp.
Product Type
Human Prescription Drug
FDA Application #
ANDA208075
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-30-2026
Listing Expiration
12-31-2027
Exclude Flag
N
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 60505-4946-1 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 20 ml in 1 vial, single-dose (60505-4946-0) of Ceftaroline Fosamil, a human prescription drug labeled by Apotex Corp.. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains ceftaroline fosamil as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Apotex Corp. on September 30, 2026. The current certification is valid through December 31, 2027.

How is this Apotex Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60505494601. 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 (5-4-1)
60505-4946-1
11-Digit CMS (5-4-2)
60505-4946-01

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