"55494-580-55" National Drug Code (NDC)

Osphena 1 BLISTER PACK in 1 PACKAGE (55494-580-55) / 5 TABLET, FILM COATED in 1 BLISTER PACK
(Duchesnay USA, Inc.)

NDC Code55494-580-55
Package Description1 BLISTER PACK in 1 PACKAGE (55494-580-55) / 5 TABLET, FILM COATED in 1 BLISTER PACK
Product NDC55494-580
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameOsphena
Non-Proprietary NameOspemifene
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20230401
Marketing Category NameNDA
Application NumberNDA203505
ManufacturerDuchesnay USA, Inc.
Substance NameOSPEMIFENE
Strength60
Strength Unitmg/1
Pharmacy ClassesEstrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]

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