"0078-1189-20" National Drug Code (NDC)

Fabhalta 60 CAPSULE in 1 BOTTLE (0078-1189-20)
(Novartis Pharmaceuticals Corporation)

NDC Code0078-1189-20
Package Description60 CAPSULE in 1 BOTTLE (0078-1189-20)
Product NDC0078-1189
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameFabhalta
Non-Proprietary NameIptacopan
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20231205
Marketing Category NameNDA
Application NumberNDA218276
ManufacturerNovartis Pharmaceuticals Corporation
Substance NameIPTACOPAN HYDROCHLORIDE
Strength200
Strength Unitmg/1

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