"69339-130-12" National Drug Code (NDC)

Zileuton 120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (69339-130-12)
(DASH Pharmaceutical LLC)

NDC Code69339-130-12
Package Description120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (69339-130-12)
Product NDC69339-130
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameZileuton
Non-Proprietary NameZileuton
Dosage FormTABLET, MULTILAYER, EXTENDED RELEASE
UsageORAL
Start Marketing Date20201023
Marketing Category NameANDA
Application NumberANDA211390
ManufacturerDASH Pharmaceutical LLC
Substance NameZILEUTON
Strength600
Strength Unitmg/1
Pharmacy Classes5-Lipoxygenase Inhibitor [EPC], 5-Lipoxygenase Inhibitors [MoA], Decreased Leukotriene Production [PE]

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