Inqovi Tablet, Film Coated
NDC Package 64842-0727-9

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

Package Information

Inqovi (cedazuridine and decitabine) tablets is iNQOVI is indicated for treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. This formulation utilizes a tablet, film coated delivery system. Marketed by Taiho Pharmaceutical Co., Ltd., this product is identified by NDC 64842-0727 and is authorized under FDA application NDA212576.

Identification & Billing

NDC Package Code
64842-0727-9
Package Description
1 BLISTER PACK in 1 CARTON / 5 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
64842-0727
11-Digit Billing Format
64842072709
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Inqovi
Non-Proprietary Name
Cedazuridine And Decitabine
Substance Name
Cedazuridine; Decitabine
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)
Pharmacologic Class
Usage Information
INQOVI is indicated for treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.

Regulatory & Marketing

Labeler Name
Taiho Pharmaceutical Co., Ltd.
Product Type
Human Prescription Drug
FDA Application #
NDA212576
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-07-2020
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 64842-0727-9 identifies a specific commercial package of 1 blister pack in 1 carton / 5 tablet, film coated in 1 blister pack of Inqovi, a human prescription drug labeled by Taiho Pharmaceutical Co., Ltd.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This tablet, film coated is formulated for oral use and contains cedazuridine; decitabine 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 Taiho Pharmaceutical Co., Ltd. on July 07, 2020. The current certification is valid through December 31, 2027.

How is this Taiho Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64842072709. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-4-1)
64842-0727-9
11-Digit CMS (5-4-2)
64842-0727-09

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