"69097-248-03" National Drug Code (NDC)

Darunavir 600 And 800 Mg 60 TABLET in 1 BOTTLE (69097-248-03)
(Cipla USA Inc.)

NDC Code69097-248-03
Package Description60 TABLET in 1 BOTTLE (69097-248-03)
Product NDC69097-248
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDarunavir 600 And 800 Mg
Non-Proprietary NameDarunavir
Dosage FormTABLET
UsageORAL
Start Marketing Date20231129
Marketing Category NameANDA
Application NumberANDA206288
ManufacturerCipla USA Inc.
Substance NameDARUNAVIR HYDRATE
Strength600
Strength Unitmg/1
Pharmacy ClassesCytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]

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