fabhalta

Generic: iptacopan

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name fabhalta
Generic Name iptacopan
Labeler novartis pharmaceuticals corporation
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

iptacopan hydrochloride 200 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-1189
Product ID 0078-1189_f0bead0e-4eed-4db9-a076-1d974eba6b4a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA218276
Listing Expiration 2026-12-31
Marketing Start 2023-12-05

Pharmacologic Class

Classes
complement factor b inhibitor [epc] complement factor b inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00781189
Hyphenated Format 0078-1189

Supplemental Identifiers

RxCUI
2671074 2671080
UNII
XW5CK7C6YH

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fabhalta (source: ndc)
Generic Name iptacopan (source: ndc)
Application Number NDA218276 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (0078-1189-20)
source: ndc

Packages (1)

0078-1189-20 60 CAPSULE in 1 BOTTLE (0078-1189-20)

Ingredients (1)

iptacopan hydrochloride (200 mg/1)

Linked Drug Pages (1)

FABHALTA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f0bead0e-4eed-4db9-a076-1d974eba6b4a", "openfda": {"unii": ["XW5CK7C6YH"], "rxcui": ["2671074", "2671080"], "spl_set_id": ["a76b5845-6e21-4d3b-ad07-cd8df1b60bee"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (0078-1189-20)", "package_ndc": "0078-1189-20", "marketing_start_date": "20231205"}], "brand_name": "FABHALTA", "product_id": "0078-1189_f0bead0e-4eed-4db9-a076-1d974eba6b4a", "dosage_form": "CAPSULE", "pharm_class": ["Complement Factor B Inhibitor [EPC]", "Complement Factor B Inhibitors [MoA]"], "product_ndc": "0078-1189", "generic_name": "iptacopan", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FABHALTA", "active_ingredients": [{"name": "IPTACOPAN HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "NDA218276", "marketing_category": "NDA", "marketing_start_date": "20231205", "listing_expiration_date": "20261231"}