NDC 64380-189

Zileuton

Zileuton

Zileuton is a Oral Tablet, Multilayer, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Strides Pharma Science Limited. The primary component is Zileuton.

Product ID64380-189_4bb0aa92-80d2-4cbc-9261-012f3b5eb1c1
NDC64380-189
Product TypeHuman Prescription Drug
Proprietary NameZileuton
Generic NameZileuton
Dosage FormTablet, Multilayer, Extended Release
Route of AdministrationORAL
Marketing Start Date2022-10-15
Marketing CategoryANDA /
Application NumberANDA212670
Labeler NameStrides Pharma Science Limited
Substance NameZILEUTON
Active Ingredient Strength600 mg/1
Pharm Classes5-Lipoxygenase Inhibitor [EPC], 5-Lipoxygenase Inhibitors [MoA], Decreased Leukotriene Production [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 64380-189-01

120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (64380-189-01)
Marketing Start Date2022-10-15
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Zileuton" or generic name "Zileuton"

NDCBrand NameGeneric Name
31722-044ZileutonZileuton
49884-723Zileutonzileuton
64380-189Zileutonzileuton
64980-206ZileutonZileuton
66993-485ZileutonZileuton
68180-169ZILEUTONZileuton
69339-130Zileutonzileuton
10122-901ZYFLOzileuton
10122-902ZYFLO CRzileuton

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