Micafungin In Sodium Chloride Injection
NDC Package 0338-9055-10

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

Package Information

Micafungin In Sodium Chloride injection is a medication used to treat a variety of fungal infections. This formulation utilizes a injection delivery system. Marketed by Baxter Healthcare Corporation, this product is identified by NDC 0338-9055 and is authorized under FDA application NDA216142.

Identification & Billing

NDC Package Code
0338-9055-10
Package Description
10 CARTON in 1 CARTON / 1 BAG in 1 CARTON (0338-9055-01) / 150 mL in 1 BAG
Product Code
0338-9055
11-Digit Billing Format
00338905510
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Micafungin In Sodium Chloride
Non-Proprietary Name
Micafungin In Sodium Chloride
Substance Name
Micafungin Sodium
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
MICAFUNGIN SODIUM 150 mg/150mL
Pharmacologic Class
Usage Information
This medication is used to treat a variety of fungal infections. It is also used to prevent fungal infections in patients who are having a stem cell transplant. Micafungin belongs to a class of drugs known as echinocandins. It works by stopping the growth of fungi.

Regulatory & Marketing

Labeler Name
Baxter Healthcare Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA216142
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-29-2023
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 0338-9055-10 identifies a specific commercial package of 10 carton in 1 carton / 1 bag in 1 carton (0338-9055-01) / 150 ml in 1 bag of Micafungin In Sodium Chloride, a human prescription drug labeled by Baxter Healthcare Corporation. This injection is formulated for intravenous use and contains micafungin sodium 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 September 29, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat a variety of fungal infections. It is also used to prevent fungal infections in patients who are having a stem cell transplant. Micafungin belongs to a class of drugs known as echinocandins. It works by stopping the growth of fungi.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00338905510. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
0338-9055-10
11-Digit CMS (5-4-2)
00338-9055-10

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