Teflaro Powder, For Solution
NDC Package 0456-0600-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Teflaro (ceftaroline fosamil) powders is ceftaroline is an antibiotic used to treat a variety of bacterial infections. This formulation utilizes a powder, for solution delivery system. Marketed by Allergan, Inc., this product is identified by NDC 0456-0600 and is authorized under FDA application NDA200327.

Identification & Billing

NDC Package Code
0456-0600-10
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0600-01)
Product Code
0456-0600
11-Digit Billing Format
00456060010
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Teflaro
Non-Proprietary Name
Ceftaroline Fosamil
Substance Name
Ceftaroline Fosamil
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
CEFTAROLINE FOSAMIL 600 mg/20mL
Pharmacologic Class
Usage Information
Ceftaroline is an antibiotic used to treat a variety of bacterial infections. This medication is known as a cephalosporin antibiotic. It works by stopping the growth of bacteria.

Regulatory & Marketing

Labeler Name
Allergan, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA200327
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-29-2010
Listing Expiration
12-31-2026
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 0456-0600-10 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 20 ml in 1 vial, single-dose (0456-0600-01) of Teflaro, a human prescription drug labeled by Allergan, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This powder, 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 Allergan, Inc. on October 29, 2010. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Ceftaroline is an antibiotic used to treat a variety of bacterial infections. This medication is known as a cephalosporin antibiotic. It works by stopping the growth of bacteria.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00456060010. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
0456-0600-10
11-Digit CMS (5-4-2)
00456-0600-10

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