Iwilfin Tablet
NDC Package 78670-150-01

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

Package Information

Iwilfin (eflornithine hydrochloride) tablets is iWILFIN (eflornithine) is indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. This formulation utilizes a tablet delivery system. Marketed by Uswm, Llc, this product is identified by NDC 78670-150 and is authorized under FDA application NDA215500.

Identification & Billing

NDC Package Code
78670-150-01
Package Description
1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE
Product Code
78670-150
11-Digit Billing Format
78670015001
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
Iwilfin
Non-Proprietary Name
Eflornithine Hydrochloride
Substance Name
Eflornithine Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
EFLORNITHINE HYDROCHLORIDE 250 mg/1
Pharmacologic Class
Usage Information
IWILFIN (eflornithine) is indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.

Regulatory & Marketing

Labeler Name
Uswm, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA215500
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-15-2024
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 78670-150-01 identifies a specific commercial package of 1 bottle in 1 carton / 100 tablet in 1 bottle of Iwilfin, a human prescription drug labeled by Uswm, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This tablet is formulated for oral use and contains eflornithine 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 Uswm, Llc on January 15, 2024. The current certification is valid through December 31, 2027.

How is this Uswm, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78670015001. 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 (5-3-2)
78670-150-01
11-Digit CMS (5-4-2)
78670-0150-01

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