Flucytosine Capsule
NDC Package 42385-984-01

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

Flucytosine capsules is flucytosine is used to treat serious fungal infections in the body. This formulation utilizes a capsule delivery system. Marketed by Laurus Labs Limited, this product is identified by NDC 42385-984 and is authorized under FDA application ANDA218005.

Identification & Billing

NDC Package Code
42385-984-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
42385-984
11-Digit Billing Format
42385098401
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Flucytosine
Non-Proprietary Name
Flucytosine
Substance Name
Flucytosine
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FLUCYTOSINE 500 mg/1
Pharmacologic Class
Usage Information
Flucytosine is used to treat serious fungal infections in the body. It belongs to a class of drugs known as antifungal drugs. It is often used with other medications. It works by slowing the growth of certain types of fungus.

Regulatory & Marketing

Labeler Name
Laurus Labs Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA218005
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-24-2025
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (42385-984). Click a package code to view its specific billing and regulatory data.

42385-984-27
10 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK

* 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 42385-984-01 identifies a specific commercial package of 100 capsule in 1 bottle of Flucytosine, a human prescription drug labeled by Laurus Labs Limited. This capsule is formulated for oral use and contains flucytosine 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 Laurus Labs Limited on July 24, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Flucytosine is used to treat serious fungal infections in the body. It belongs to a class of drugs known as antifungal drugs. It is often used with other medications. It works by slowing the growth of certain types of fungus.

How is this Laurus Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42385098401. 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 (5-3-2)
42385-984-01
11-Digit CMS (5-4-2)
42385-0984-01

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