Inrebic Capsule
NDC Package 59572-720-12

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

Package Information

Inrebic (fedratinib hydrochloride) capsules is a medication used to treat a certain type of cancer (myelofibrosis). This formulation utilizes a capsule delivery system. Marketed by Celgene Corporation, this product is identified by NDC 59572-720 and is authorized under FDA application NDA212327.

Identification & Billing

NDC Package Code
59572-720-12
Package Description
120 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
59572-720
11-Digit Billing Format
59572072012
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
120 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Inrebic
Non-Proprietary Name
Fedratinib Hydrochloride
Substance Name
Fedratinib Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FEDRATINIB HYDROCHLORIDE 100 mg/1
Usage Information
This medication is used to treat a certain type of cancer (myelofibrosis). Fedratinib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of cancer cells.

Regulatory & Marketing

Labeler Name
Celgene Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA212327
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-16-2019
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 59572-720-12 identifies a specific commercial package of 120 capsule in 1 bottle, plastic of Inrebic, a human prescription drug labeled by Celgene Corporation. This product is billed for "EA" each discreet unit and contains an estimated amount of 120 billable units per package. This capsule is formulated for oral use and contains fedratinib hydrochloride 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 Celgene Corporation on August 16, 2019. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat a certain type of cancer (myelofibrosis). Fedratinib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of cancer cells.

How is this Celgene Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59572072012. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 120 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)
59572-720-12
11-Digit CMS (5-4-2)
59572-0720-12

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