Cefepime Injection, Powder, For Solution
NDC Package 63323-340-20

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

Package Information

Cefepime injection is cefepime is used to treat a wide variety of bacterial infections. This formulation utilizes a injection, powder, for solution delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-340 and is authorized under FDA application ANDA065441.

Identification & Billing

NDC Package Code
63323-340-20
Package Description
10 VIAL in 1 CARTON / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (63323-340-21)
Product Code
63323-340
11-Digit Billing Format
63323034020
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cefepime
Non-Proprietary Name
Cefepime
Substance Name
Cefepime Hydrochloride
Dosage Form
Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
CEFEPIME HYDROCHLORIDE 2 g/1
Pharmacologic Class
Usage Information
Cefepime 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.

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA065441
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-30-2010
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 63323-340-20 identifies a specific commercial package of 10 vial in 1 carton / 1 injection, powder, for solution in 1 vial (63323-340-21) of Cefepime, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This injection, powder, for solution is formulated for intravenous use and contains cefepime hydrochloride 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 Fresenius Kabi Usa, Llc on August 30, 2010. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Cefepime 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.

How is this Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63323034020. 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 (5-3-2)
63323-340-20
11-Digit CMS (5-4-2)
63323-0340-20

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