"82293-041-10" National Drug Code (NDC)

Macitentan 1 BLISTER PACK in 1 CARTON (82293-041-10) / 15 TABLET, FILM COATED in 1 BLISTER PACK
(Novugen Pharma (USA) LLC)

NDC Code82293-041-10
Package Description1 BLISTER PACK in 1 CARTON (82293-041-10) / 15 TABLET, FILM COATED in 1 BLISTER PACK
Product NDC82293-041
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMacitentan
Non-Proprietary NameMacitentan
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20260507
Marketing Category NameANDA
Application NumberANDA211026
ManufacturerNovugen Pharma (USA) LLC
Substance NameMACITENTAN
Strength10
Strength Unitmg/1
Pharmacy ClassesEndothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]

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