NDC Package 71334-100-01 Tibsovo

Ivosidenib Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

71334-100-01

Package Description:

60 TABLET, FILM COATED in 1 BOTTLE

Product Code:

71334-100

Proprietary Name:

Tibsovo

Non-Proprietary Name:

Ivosidenib

Substance Name:

Ivosidenib

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.

11-Digit NDC Billing Format:

71334010001

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

60 EA

NDC to RxNorm Crosswalk:

RxCUI: 2049878 - ivosidenib 250 MG Oral Tablet

RxCUI: 2049884 - TIBSOVO 250 MG Oral Tablet

RxCUI: 2049884 - ivosidenib 250 MG Oral Tablet [Tibsovo]

RxCUI: 2049884 - Tibsovo 250 MG Oral Tablet

Product Type:

Human Prescription Drug

Labeler Name:

Agios Pharmaceuticals, Inc.

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(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

IVOSIDENIB 250 mg/1

Sample Package:

FDA Application Number:

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

Exclude Flag:

Code Structure:

71334 - Agios Pharmaceuticals, Inc.
- 71334-100 - Tibsovo
  - 71334-100-01 - 60 TABLET, FILM COATED in 1 BOTTLE

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 disclaimer below.

Frequently Asked Questions

What is NDC 71334-100-01?

The NDC Packaged Code 71334-100-01 is assigned to a package of 60 tablet, film coated in 1 bottle of Tibsovo, a human prescription drug labeled by Agios Pharmaceuticals, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package.

Is NDC 71334-100 included in the NDC Directory?

Yes, Tibsovo with product code 71334-100 is active and included in the NDC Directory. The product was first marketed by Agios Pharmaceuticals, Inc. on July 20, 2018.

What is the NDC billing unit for package 71334-100-01?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 60.

What is the 11-digit format for NDC 71334-100-01?

The 11-digit format is 71334010001. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	71334-100-01	5-4-2	71334-0100-01

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