"42385-907-15" National Drug Code (NDC)

Macitentan 1 BLISTER PACK in 1 CARTON (42385-907-15) / 15 TABLET, FILM COATED in 1 BLISTER PACK
(Laurus Labs Limited)

NDC Code42385-907-15
Package Description1 BLISTER PACK in 1 CARTON (42385-907-15) / 15 TABLET, FILM COATED in 1 BLISTER PACK
Product NDC42385-907
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMacitentan
Non-Proprietary NameMacitentan
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20260515
Marketing Category NameANDA
Application NumberANDA211120
ManufacturerLaurus Labs Limited
Substance NameMACITENTAN
Strength10
Strength Unitmg/1
Pharmacy ClassesEndothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]

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