Isoniazid Tablet
NDC Package 10135-804-01

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

Package Information

Isoniazid tablets is isoniazid is used with other medications to treat active tuberculosis (TB) infections. This formulation utilizes a tablet delivery system. Marketed by Marlex Pharmaceuticals, Inc., this product is identified by NDC 10135-804 and is authorized under FDA application ANDA040090.

Identification & Billing

NDC Package Code
10135-804-01
Package Description
100 TABLET in 1 BOTTLE, PLASTIC
Product Code
10135-804
11-Digit Billing Format
10135080401
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Isoniazid
Non-Proprietary Name
Isoniazid
Substance Name
Isoniazid
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ISONIAZID 100 mg/1
Pharmacologic Class
Antimycobacterial - [EPC] (Established Pharmacologic Class)
Usage Information
Isoniazid is used with other medications to treat active tuberculosis (TB) infections. It is also used alone to prevent active TB infections in people who may be infected with the bacteria (people with positive TB skin test). Isoniazid is an antibiotic and works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

Regulatory & Marketing

Labeler Name
Marlex Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA040090
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-01-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 10135-804-01 identifies a specific commercial package of 100 tablet in 1 bottle, plastic of Isoniazid, a human prescription drug labeled by Marlex Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This tablet is formulated for oral use and contains isoniazid 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 Marlex Pharmaceuticals, Inc. on March 01, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Isoniazid is used with other medications to treat active tuberculosis (TB) infections. It is also used alone to prevent active TB infections in people who may be infected with the bacteria (people with positive TB skin test). Isoniazid is an antibiotic and works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

How is this Marlex Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10135080401. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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 (5-3-2)
10135-804-01
11-Digit CMS (5-4-2)
10135-0804-01

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