Cefepime Hydrochloride And Dextrose Injection, Solution
NDC Package 0264-3193-11

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

Package Information

Cefepime Hydrochloride And Dextrose (cefepime hydrochloride) injection is to reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefepime for Injection USP and Dextrose Injection USP and other antibacterial drugs, Cefepime for Injection USP and Dextrose Injection USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. This formulation utilizes a injection, solution delivery system. Marketed by B. Braun Medical Inc., this product is identified by NDC 0264-3193 and is authorized under FDA application NDA050821.

Identification & Billing

NDC Package Code
0264-3193-11
Package Description
24 CONTAINER in 1 CASE / 50 mL in 1 CONTAINER
Product Code
0264-3193
11-Digit Billing Format
00264319311
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
Cefepime Hydrochloride And Dextrose
Non-Proprietary Name
Cefepime Hydrochloride
Substance Name
Cefepime Hydrochloride
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
CEFEPIME HYDROCHLORIDE 1 g/50mL
Pharmacologic Class
Usage Information
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefepime for Injection USP and Dextrose Injection USP and other antibacterial drugs, Cefepime for Injection USP and Dextrose Injection USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Regulatory & Marketing

Labeler Name
B. Braun Medical Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA050821
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-06-2010
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 0264-3193-11 identifies a specific commercial package of 24 container in 1 case / 50 ml in 1 container of Cefepime Hydrochloride And Dextrose, a human prescription drug labeled by B. Braun Medical Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, 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 B. Braun Medical Inc. on May 06, 2010. The current certification is valid through December 31, 2027.

How is this B. Braun Medical Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00264319311. 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)
0264-3193-11
11-Digit CMS (5-4-2)
00264-3193-11

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