"69238-1327-3" National Drug Code (NDC)

Macitentan 1 BOTTLE in 1 CARTON (69238-1327-3) / 30 TABLET, FILM COATED in 1 BOTTLE
(Amneal Pharmaceuticals NY LLC)

NDC Code69238-1327-3
Package Description1 BOTTLE in 1 CARTON (69238-1327-3) / 30 TABLET, FILM COATED in 1 BOTTLE
Product NDC69238-1327
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMacitentan
Non-Proprietary NameMacitentan
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20260608
Marketing Category NameANDA
Application NumberANDA211000
ManufacturerAmneal Pharmaceuticals NY LLC
Substance NameMACITENTAN
Strength10
Strength Unitmg/1
Pharmacy ClassesEndothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]

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