Kodatef Tablet, Film Coated
NDC Package 71475-258-03

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

Package Information

Kodatef (tafenoquine) tablets is malaria prophylaxis, consistent with the approved use of ARAKODA. This formulation utilizes a tablet, film coated delivery system. Marketed by 60 Degrees Pharmaceuticals, Inc, this product is identified by NDC 71475-258.

Identification & Billing

NDC Package Code
71475-258-03
Package Description
1 TABLET, FILM COATED in 1 CARTON
Product Code
71475-258
11-Digit Billing Format
71475025803
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Kodatef
Non-Proprietary Name
Tafenoquine
Substance Name
Tafenoquine
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TAFENOQUINE 100 mg/1
Usage Information
Malaria prophylaxis, consistent with the approved use of ARAKODA

Regulatory & Marketing

Labeler Name
60 Degrees Pharmaceuticals, Inc
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE -
Start Marketing Date
02-20-2025
End Marketing Date
09-30-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71475-258-03 identifies a specific commercial package of 1 tablet, film coated in 1 carton of Kodatef, a human prescription drug labeled by 60 Degrees Pharmaceuticals, Inc. This tablet, film coated is formulated for oral use and contains tafenoquine 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 60 Degrees Pharmaceuticals, Inc on February 20, 2025.

How is this 60 Degrees Pharmaceuticals, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71475025803. 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)
71475-258-03
11-Digit CMS (5-4-2)
71475-0258-03

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