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  5. NDC Package Code: 0078-1189-20 Fabhalta

NDC Package 0078-1189-20 Fabhalta

Iptacopan Capsule 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:
0078-1189-20
Package Description:
60 CAPSULE in 1 BOTTLE
Product Code:
0078-1189
Proprietary Name:
Fabhalta
Non-Proprietary Name:
Iptacopan
Substance Name:
Iptacopan Hydrochloride
Usage Information:
FABHALTA is indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).
11-Digit NDC Billing Format:
00078118920
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: 2671074 - iptacopan 200 MG Oral Capsule
  • RxCUI: 2671074 - iptacopan 200 MG (as iptacopan hydrochloride 225.8 MG) Oral Capsule
  • RxCUI: 2671080 - FABHALTA 200 MG Oral Capsule
  • RxCUI: 2671080 - iptacopan 200 MG Oral Capsule [Fabhalta]
  • RxCUI: 2671080 - Fabhalta 200 MG (as iptacopan hydrochloride 225.8 MG) Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Novartis Pharmaceuticals Corporation
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • IPTACOPAN HYDROCHLORIDE 200 mg/1
    • Sample Package:
    No
    FDA Application Number:
    NDA218276
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-05-2023
    Listing Expiration Date:
    12-31-2025
    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 0078-1189-20?

    The NDC Packaged Code 0078-1189-20 is assigned to a package of 60 capsule in 1 bottle of Fabhalta, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is capsule 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 0078-1189 included in the NDC Directory?

    Yes, Fabhalta with product code 0078-1189 is active and included in the NDC Directory. The product was first marketed by Novartis Pharmaceuticals Corporation on December 05, 2023 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0078-1189-20?

    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 0078-1189-20?

    The 11-digit format is 00078118920. 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 4-4-2 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
    4-4-20078-1189-205-4-200078-1189-20