Tibsovo
NDC Package 71334-100-01

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Tibsovo is a medication used to treat a certain type of blood cell cancer (acute myeloid leukemia-AML). Marketed by Agios Pharmaceuticals, Inc., this product is identified by NDC 71334-100 and is authorized under FDA application NDA211192.

Identification & Billing

NDC Package Code
71334-100-01
Package Description
60 TABLET, FILM COATED in 1 BOTTLE
Product Code
71334-100
11-Digit Billing Format
71334010001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA

Clinical Specifications

Proprietary Name
Tibsovo
Dosage Form
-
Usage Information
This medication is used to treat a certain type of blood cell cancer (acute myeloid leukemia-AML). Ivosidenib works by helping your bone marrow grow normal blood cells so you will need fewer blood transfusions.

Regulatory & Marketing

Labeler Name
Agios Pharmaceuticals, Inc.
FDA Application #
NDA211192
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-20-2018
End Marketing Date
11-30-2024
Listing Expiration
11-30-2024
Exclude Flag
D
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 71334-100-01 identifies a specific commercial package of 60 tablet, film coated in 1 bottle of Tibsovo, labeled by Agios Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Agios Pharmaceuticals, Inc. on July 20, 2018. The current certification is valid through November 30, 2024.

What are the primary indications for this medication?

This medication is used to treat a certain type of blood cell cancer (acute myeloid leukemia-AML). Ivosidenib works by helping your bone marrow grow normal blood cells so you will need fewer blood transfusions.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71334010001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
71334-100-01
11-Digit CMS (5-4-2)
71334-0100-01

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