Prescription drug · NDA
Fabhalta (iptacopan) NDC 0078-1189
Iptacopan hydrochloride 200 mg/1 · Capsule · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| 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
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 218276
- Marketing start
- Listing expires
- 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
N400078118920followed by a unit qualifier and the quantityPackage 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 . 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.