Fabhalta Capsule
NDC Package 0078-1189-20

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

Package Information

Fabhalta (iptacopan) capsules is fABHALTA is indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). This formulation utilizes a capsule delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-1189 and is authorized under FDA application NDA218276.

Identification & Billing

NDC Package Code
0078-1189-20
Package Description
60 CAPSULE in 1 BOTTLE
Product Code
0078-1189
11-Digit Billing Format
00078118920
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fabhalta
Non-Proprietary Name
Iptacopan
Substance Name
Iptacopan 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)
IPTACOPAN HYDROCHLORIDE 200 mg/1
Pharmacologic Class
Usage Information
FABHALTA is indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA218276
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-05-2023
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 0078-1189-20 identifies a specific commercial package of 60 capsule in 1 bottle of Fabhalta, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This capsule is formulated for oral use and contains iptacopan 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 Novartis Pharmaceuticals Corporation on December 05, 2023. The current certification is valid through December 31, 2027.

How is this Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078118920. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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 (4-4-2)
0078-1189-20
11-Digit CMS (5-4-2)
00078-1189-20

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