Micafungin Injection, Powder, Lyophilized, For Solution
NDC Package 67184-0589-2

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

Package Information

Micafungin injection is micafungin for injection is indicated for:Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)]Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see Use in Specific Populations (8.4)].Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.2)].Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies (14.3)]. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Qilu Pharmaceutical Co., Ltd, this product is identified by NDC 67184-0589 and is authorized under FDA application ANDA219273.

Identification & Billing

NDC Package Code
67184-0589-2
Package Description
10 VIAL in 1 CARTON / 5 mL in 1 VIAL
Product Code
67184-0589
11-Digit Billing Format
67184058902
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Micafungin
Non-Proprietary Name
Micafungin
Substance Name
Micafungin
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
MICAFUNGIN 10 mg/mL
Pharmacologic Class
Usage Information
Micafungin for injection is indicated for:Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)]Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see Use in Specific Populations (8.4)].Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.2)].Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies (14.3)]. Limitations of UseThe safety and effectiveness of micafungin for injection has not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age as a higher dose may be needed [see Use in Specific Populations (8.4)].Micafungin for injection has not been adequately studied in patients with endocarditis, osteomyelitis and meningoencephalitis due to Candida. The efficacy of micafungin for injection against infections caused by fungi other than Candida has not been established.

Regulatory & Marketing

Labeler Name
Qilu Pharmaceutical Co., Ltd
Product Type
Human Prescription Drug
FDA Application #
ANDA219273
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-03-2025
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (67184-0589). Click a package code to view its specific billing and regulatory data.

67184-0589-1
1 VIAL in 1 CARTON / 5 mL in 1 VIAL

* 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 67184-0589-2 identifies a specific commercial package of 10 vial in 1 carton / 5 ml in 1 vial of Micafungin, a human prescription drug labeled by Qilu Pharmaceutical Co., Ltd. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains micafungin 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 Qilu Pharmaceutical Co., Ltd on April 03, 2025. The current certification is valid through December 31, 2027.

How is this Qilu Pharmaceutical Co., Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67184058902. 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)
67184-0589-2
11-Digit CMS (5-4-2)
67184-0589-02

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