"70710-1166-3" National Drug Code (NDC)

Macitentan 30 TABLET, FILM COATED in 1 BOTTLE (70710-1166-3)
(Zydus Pharmaceuticals USA Inc.)

NDC Code70710-1166-3
Package Description30 TABLET, FILM COATED in 1 BOTTLE (70710-1166-3)
Product NDC70710-1166
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMacitentan
Non-Proprietary NameMacitentan
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20251105
End Marketing Date20251106
Marketing Category NameANDA
Application NumberANDA211224
ManufacturerZydus Pharmaceuticals USA Inc.
Substance NameMACITENTAN
Strength10
Strength Unitmg/1
Pharmacy ClassesEndothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]

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