"81153-100-01" National Drug Code (NDC)

Orlynvah 1 BOTTLE in 1 CARTON (81153-100-01) / 10 TABLET, FILM COATED in 1 BOTTLE
(ITERUM THERAPEUTICS US LIMITED)

NDC Code81153-100-01
Package Description1 BOTTLE in 1 CARTON (81153-100-01) / 10 TABLET, FILM COATED in 1 BOTTLE
Product NDC81153-100
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameOrlynvah
Non-Proprietary NameSulopenem Etzadroxil And Probenecid
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20250701
Marketing Category NameNDA
Application NumberNDA213972
ManufacturerITERUM THERAPEUTICS US LIMITED
Substance NamePROBENECID; SULOPENEM ETZADROXIL
Strength500; 500
Strength Unitmg/1; mg/1

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