NDC 69339-130

Zileuton

Zileuton

Zileuton is a Oral Tablet, Multilayer, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Dash Pharmaceutical Llc. The primary component is Zileuton.

Product ID69339-130_b3442eca-c955-4cf9-e053-2995a90a1876
NDC69339-130
Product TypeHuman Prescription Drug
Proprietary NameZileuton
Generic NameZileuton
Dosage FormTablet, Multilayer, Extended Release
Route of AdministrationORAL
Marketing Start Date2020-10-23
Marketing CategoryANDA / ANDA
Application NumberANDA211390
Labeler NameDASH Pharmaceutical LLC
Substance NameZILEUTON
Active Ingredient Strength600 mg/1
Pharm Classes5-Lipoxygenase Inhibitors [MoA],Decreased Leukotriene Production [PE],5-Lipoxygenase Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 69339-130-12

120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (69339-130-12)
Marketing Start Date2020-10-23
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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