Isoniazid Solution
NDC Package 62135-550-47

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

Package Information

Isoniazid solution is isoniazid is used with other medications to treat active tuberculosis (TB) infections. This formulation utilizes a solution delivery system. Marketed by Chartwell Rx, Llc, this product is identified by NDC 62135-550 and is authorized under FDA application ANDA081118.

Identification & Billing

NDC Package Code
62135-550-47
Package Description
473 mL in 1 BOTTLE
Product Code
62135-550
11-Digit Billing Format
62135055047
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Isoniazid
Non-Proprietary Name
Isoniazid
Substance Name
Isoniazid
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ISONIAZID 50 mg/5mL
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
Chartwell Rx, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA081118
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-21-1997
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 62135-550-47 identifies a specific commercial package of 473 ml in 1 bottle of Isoniazid, a human prescription drug labeled by Chartwell Rx, Llc. This product is billed per "ML" milliliter and contains an estimated amount of 473 billable units per package. This solution 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 Chartwell Rx, Llc on July 21, 1997. 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 Chartwell Rx, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62135055047. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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)
62135-550-47
11-Digit CMS (5-4-2)
62135-0550-47

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