"0378-0606-93" National Drug Code (NDC)

Macitentan 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0606-93)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-0606-93
Package Description30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0606-93)
Product NDC0378-0606
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMacitentan
Non-Proprietary NameMacitentan
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20260608
Marketing Category NameANDA
Application NumberANDA211161
ManufacturerMylan Pharmaceuticals Inc.
Substance NameMACITENTAN
Strength10
Strength Unitmg/1
Pharmacy ClassesEndothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]

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