Krintafel Tablet, Film Coated
NDC Package 0173-0889-39

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

Package Information

Krintafel (tafenoquine succinate) tablets is tafenoquine is used in combination with another medication (such as chloroquine) to treat and prevent the return of malaria. This formulation utilizes a tablet, film coated delivery system. Marketed by Glaxosmithkline Llc, this product is identified by NDC 0173-0889 and is authorized under FDA application NDA210795.

Identification & Billing

NDC Package Code
0173-0889-39
Package Description
2 TABLET, FILM COATED in 1 BOTTLE
Product Code
0173-0889
11-Digit Billing Format
00173088939
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
2 EA

Clinical Specifications

Proprietary Name
Krintafel
Non-Proprietary Name
Tafenoquine Succinate
Substance Name
Tafenoquine Succinate
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 SUCCINATE 150 mg/1
Usage Information
Tafenoquine is used in combination with another medication (such as chloroquine) to treat and prevent the return of malaria. Malaria is caused by infection with a parasite spread by mosquito bite. After they multiply and grow, the parasites infect your red blood cells and cause symptoms of malaria (such as fever, chills, sweating, headache, other flu-like symptoms). This medication works by stopping the growth of the parasite that causes malaria.

Regulatory & Marketing

Labeler Name
Glaxosmithkline Llc
Product Type
Human Prescription Drug
FDA Application #
NDA210795
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-22-2019
Listing Expiration
12-31-2027
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 0173-0889-39 identifies a specific commercial package of 2 tablet, film coated in 1 bottle of Krintafel, a human prescription drug labeled by Glaxosmithkline Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 2 billable units per package. This tablet, film coated is formulated for oral use and contains tafenoquine succinate 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 Glaxosmithkline Llc on January 22, 2019. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Tafenoquine is used in combination with another medication (such as chloroquine) to treat and prevent the return of malaria. Malaria is caused by infection with a parasite spread by mosquito bite. After they multiply and grow, the parasites infect your red blood cells and cause symptoms of malaria (such as fever, chills, sweating, headache, other flu-like symptoms). This medication works by stopping the growth of the parasite that causes malaria.

How is this Glaxosmithkline Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00173088939. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2 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 (4-4-2)
0173-0889-39
11-Digit CMS (5-4-2)
00173-0889-39

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