Isoniazid Powder
NDC Package 43367-0100-1

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Isoniazid powders is isoniazid is used with other medications to treat active tuberculosis (TB) infections. This formulation utilizes a powder delivery system. Marketed by Topchem Pharmaceuticals Ltd, this product is identified by NDC 43367-0100.

Identification & Billing

NDC Package Code
43367-0100-1
Package Description
2.7 kg in 1 BOTTLE
Product Code
43367-0100
11-Digit Billing Format
43367010001

Clinical Specifications

Proprietary Name
Isoniazid
Non-Proprietary Name
Isoniazid
Substance Name
Isoniazid
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
ISONIAZID 1 kg/kg
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
Topchem Pharmaceuticals Ltd
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
01-01-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 43367-0100-1 identifies a specific commercial package of 2.7 kg in 1 bottle of Isoniazid (UNFINISHED drug), a bulk ingredient labeled by Topchem Pharmaceuticals Ltd. This powder is formulated for 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 Topchem Pharmaceuticals Ltd on January 01, 2018. 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 Topchem Pharmaceuticals Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43367010001. 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)
43367-0100-1
11-Digit CMS (5-4-2)
43367-0100-01

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