Cefepime Injection, Powder, For Solution
NDC Package 66288-8100-1

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 Samson Medical Technologies Llc, this product is identified by NDC 66288-8100 and is authorized under FDA application ANDA209408.

Identification & Billing

NDC Package Code
66288-8100-1
Package Description
1 BAG in 1 BAG / 1 INJECTION, POWDER, FOR SOLUTION in 1 BAG
Product Code
66288-8100
11-Digit Billing Format
66288810001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
RxCUI: 2058953 - cefepime 100 MG/ML Injectable Solution

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 100 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
Samson Medical Technologies Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA209408
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-01-2018
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 66288-8100-1 identifies a specific commercial package of 1 bag in 1 bag / 1 injection, powder, for solution in 1 bag of Cefepime, a human prescription drug labeled by Samson Medical Technologies Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 Samson Medical Technologies Llc on October 01, 2018. 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 Samson Medical Technologies Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66288810001. 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 (5-4-1)
66288-8100-1
11-Digit CMS (5-4-2)
66288-8100-01

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