What is NDC 0078-1189?

0078-1189 is the product NDC for Fabhalta (iptacopan), Iptacopan hydrochloride 200 mg/1 capsule, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.

Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Fabhalta?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fabhalta NDC 0078-1189 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0078-1189Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00078-1189Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0078-1189-20	00078118920	60 CAPSULE in 1 BOTTLE (0078-1189-20)Marketed from Dec 5, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Fabhalta
Generic name (nonproprietary): iptacopan
Active ingredients: Iptacopan hydrochloride — 200 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Novartis Pharmaceuticals CorporationNDC labeler code 0078
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 218276
Marketing start: Dec 5, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Complement Factor B Inhibitors (Mechanism)
Identifiers: Product ID 0078-1189_be81b091-bf01-4e82-b777-e90a0f697c37SPL ID be81b091-bf01-4e82-b777-e90a0f697c37SPL set ID a76b5845-6e21-4d3b-ad07-cd8df1b60beeRxCUI 2671074, 2671080UNII XW5CK7C6YH
Pharmacologic class: Complement Factor B Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400078118920 followed by a unit qualifier and the quantity

Package 00078-1189-20. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jul 16, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

FABHALTA is a complement factor B inhibitor, indicated for: the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). ( 1.1 ) slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression. ( 1.2 ) the treatment of adults with complement 3 glomerulopathy (C3G), to reduce proteinuria. ( 1.3 ) 1.1 Paroxysmal Nocturnal Hemoglobinuria FABHALTA is indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). 1.2 Immunoglobulin A Nephropathy FABHALTA is indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression. 1.3 Complement 3 G…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0078-1189

What is NDC 0078-1189?: 0078-1189 is the product NDC for Fabhalta (iptacopan), Iptacopan hydrochloride 200 mg/1 capsule, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Fabhalta (Iptacopan).
What is the active ingredient?: Iptacopan hydrochloride.
Who is the labeler?: Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fabhalta?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Fabhalta (Iptacopan) NDC 0078-1189