Cefepime Injection, Solution
NDC Package 0338-1301-41

11-digit billing NDC: 00338130141 · Billing unit: ML · 1200 ML per package
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Cefepime injection is in Galaxy Container is for intravenous administration using sterile equipment after thawing to room temperature.Thawing of Plastic ContainerThaw frozen container at room temperature 25°C (77°F) or under refrigeration 5°C (41°F). This formulation utilizes a injection, solution delivery system. Marketed by Baxter Healthcare Corporation, this product is identified by NDC 0338-1301 and is authorized under FDA application NDA050817.

Identification & Billing

NDC Package Code
0338-1301-41
Package Description
24 BAG in 1 BOX / 50 mL in 1 BAG
Product Code
0338-1301
11-Digit Billing Format
00338130141
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
1200 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cefepime
Non-Proprietary Name
Cefepime
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
Cefepime Injection in Galaxy Container is for intravenous administration using sterile equipment after thawing to room temperature.Thawing of Plastic ContainerThaw frozen container at room temperature 25°C (77°F) or under refrigeration 5°C (41°F). Do not force thaw by immersion in water baths or by microwave irradiation.[See How Supplied/Storage and Handling (16).] Check for minute leaks by squeezing container firmly. If leaks are detected, discard solution as sterility may be impaired.Do not add supplementary medication.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected. Agitate after solution has reached room temperature. If after visual inspection the solution remains cloudy or if an insoluble precipitate is noted or if any seals are not intact, the container should be discarded.Caution: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.Preparation for intravenous administration.1.Suspend container from eyelet support.2.Remove protector from outlet port at bottom of container.3.Attach administration set. Refer to complete directions accompanying set.Cefepime Injection should be administered intravenously over approximately 30 minutes.Intermittent intravenous infusion with a Y-type administration set can be accomplished with compatible solutions. However, during infusion of Cefepime Injection, it is desirable to discontinue the other solution.Solutions of cefepime, like those of most beta-lactam antibacterial drugs, should not be added to solutions of ampicillin at a concentration greater than 40 mg per mL, and should not be added to metronidazole, vancomycin, gentamicin, tobramycin, netilmicin sulfate or aminophylline because of potential interaction. However, if concurrent therapy with cefepime is indicated, each of these antibacterials can be administered separately.As with other cephalosporins, the color of Cefepime Injection tend to darken depending on storage conditions; however, when stored as recommended, the product potency is not adversely affected.

Regulatory & Marketing

Labeler Name
Baxter Healthcare Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA050817
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-05-2008
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J0701
Source: ASP
Inj. cefepime hcl (baxter)
HCPCS Dosage 500 MG
Units / Pkg 48

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0338-1301). Click a package code to view its specific billing and regulatory data.

0338-1301-48
12 BAG in 1 BOX / 100 mL in 1 BAG

* 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 0338-1301-41 identifies a specific commercial package of 24 bag in 1 box / 50 ml in 1 bag of Cefepime, a human prescription drug labeled by Baxter Healthcare Corporation. This product is billed per "ML" milliliter and contains an estimated amount of 1200 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 Baxter Healthcare Corporation on August 05, 2008. The current certification is valid through December 31, 2027.

How is this Baxter Healthcare Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00338130141. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 1200 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)
0338-1301-41
11-Digit CMS (5-4-2)
00338-1301-41

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