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  5. NDC Package Code: 78670-150-01 Iwilfin

NDC Package 78670-150-01 Iwilfin

Eflornithine Hydrochloride Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
78670-150-01
Package Description:
1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE
Product Code:
78670-150
Proprietary Name:
Iwilfin
Non-Proprietary Name:
Eflornithine Hydrochloride
Substance Name:
Eflornithine Hydrochloride
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.
11-Digit NDC Billing Format:
78670015001
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2673199 - eflornithine 192 MG Oral Tablet
  • RxCUI: 2673199 - eflornithine 192 MG (equivalent to eflornithine HCl 250 MG) Oral Tablet
  • RxCUI: 2673205 - iwilfin 192 MG Oral Tablet
  • RxCUI: 2673205 - eflornithine 192 MG Oral Tablet [Iwilfin]
  • RxCUI: 2673205 - Iwilfin 192 MG (equivalent to eflornithine HCl 250 MG) Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Uswm, Llc
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • EFLORNITHINE HYDROCHLORIDE 250 mg/1
    • Pharmacologic Class(es):
  • Antiprotozoal - [EPC] (Established Pharmacologic Class)
  • Decarboxylase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Decarboxylase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA215500
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    01-15-2024
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 78670-150-01?

    The NDC Packaged Code 78670-150-01 is assigned to a package of 1 bottle in 1 carton / 100 tablet in 1 bottle of Iwilfin, a human prescription drug labeled by Uswm, Llc. The product's dosage form is tablet and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 78670-150 included in the NDC Directory?

    Yes, Iwilfin with product code 78670-150 is active and included in the NDC Directory. The product was first marketed by Uswm, Llc on January 15, 2024 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 78670-150-01?

    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 1.

    What is the 11-digit format for NDC 78670-150-01?

    The 11-digit format is 78670015001. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-278670-150-015-4-278670-0150-01